J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.

The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.

Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.

The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.

The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.

J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

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YouTube teams up with providers, healthcare groups to combat health misinformation

The video-sharing giant is partnering with providers and groups, like Mayo Clinic and the American Public Health Association, to create evidence-based health content. YouTube has also added CVS Health’s former chief community health officer to lead those efforts.

IO Biotech raises $155m to develop breakthrough cancer vaccine

IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology that has boosted efficacy of PD-1 immunotherapy in early trials.

The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its lead immune-oncology therapies IO102 and IO103, with anti-PD-1 monoclonal antibodies for patients with metastatic melanoma.

IO Biotech intends to use the proceeds from the financing to advance clinical trials for its early and late-stage immune-oncology programs, including a large randomised trial for the IO102 and IO103 with anti-PD-1 combination in metastatic melanoma.

IO102 and IO103 are cancer first-in-class vaccines based on IO Biotech’s proprietary T-win technology platform.

The company said this enables the identification of compounds with a dual mechanism of action targeting and killing immunosuppressive cells and tumour cells while indirectly activating other T-effectors.

They are designed to engage and activate IDO and PD-L1 specific human T-cells, which leads to strong anti-tumour responses without adding additional safety concern.

The FDA’s decision to grant breakthrough therapy designation was based on data from the MM1636 phase 1/2 clinical trial of 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1 monoclonal antibodies.

According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology  Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data.

An overall response rate (ORR) of 79% was reached and 45% of patients achieved a complete response (CR), or complete disappearance of their tumours. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumour site.

The financing round was led by HBM Healthcare Investments with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures.

Other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital, Samsara Biocapital, Idinvest Partners (Subsidiary of Eurazeo), PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital.

IO biotech was created and launched by Novo Seeds in 2015, which is the investment arm of Novo Holdings, a private company wholly owned by the Novo Nordisk Foundation.

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UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens

The UK government has promised a “massive uplift” in the number of coronavirus vaccinations carried out this week, while conceding a target of 13.9 million jabs offered by the end of February will be “challenging”.

As the number of daily recorded cases in the country exceeded 60,000 for the first time, vaccine minister Nadhim Zahawi told BBC Radio 4’s today programme: “My absolute focus is to get to 13.9 million…offered a vaccine by the middle of February.

“That is my target and I’m confident the NHS has a plan and we will meet that target.”

The number of vaccinations will continue to rise, he promised, adding that a quarter of over-80s had already been vaccinated.

Zahawi stopped short of saying when the government would reach the 300,000 vaccinations a day required to meet the goal.

More than a million people are thought to be infected with virus at the moment and hospitals across in the worst-affected areas are running at full capacity because of the disease.

All of the country is now in a strict lockdown, with mixing indoors banned and people instructed to stay except to get exercise and other essential tasks such as buying food.

According to reports elsewhere there are a number of backlogs that are causing delays to the roll-out of the vaccine from AstraZeneca, which will be offered to the majority of patients.

The UK has ordered 100 million doses of the vaccine and AZ has reportedly manufactured around 3.5 million doses in addition to the half million or so shots that are already available.

But Sky News reported that the extra doses are still waiting to be batch tested by the country’s regulator, the Medicines and Healthcare Products Regulatory Agency.

Sky reported that the MHRA is working in parallel with AstraZeneca’s own batch testing system to speed up a process that usually takes up to three weeks.

There are also issues with Pfizer/BioNTech vaccine, which is not manufactured in the UK like the AZ shot but in Belgium.

It has already been placed into glass vials by the time it arrives in the country, but a worldwide shortage of these means that five million doses have been delivered.

This is less than half the number that should have been because of the problems with manufacturing including the fill-and-finish process, according to the BBC.

Feature image courtesy of NIH/Rocky Mountain Laboratories

 

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FDA and doctors warn against extending COVID-19 vaccine dose gap

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots.

The regulator made its comments after the UK announced a policy of stretching the gap between doses of the vaccine to up to 12 weeks to ensure maximum coverage of vulnerable groups.

The UK’s Joint Committee for Vaccines and Immunisation (JCVI) has recommended prioritising the first shot of the vaccines from Pfizer/BioNTech and AstraZeneca – but said that the follow-up booster dose can be delayed by up to 12 weeks.

According to the UK’s drug regulator the Pfizer/BioNTech vaccine doses should be taken at least 21 days apart while AZ vaccine’s booster doses should be given between four and 12 weeks apart.

But the FDA has issued a statement warning against such a strategy and reminded the public about the importance of receiving their second dose on time.

In the US, the Pfizer and BioNTech vaccine and a rival from Moderna is approved with a four-week gap between doses, but the AstraZeneca vaccine is not.

The FDA said it had been monitoring discussions and news reports about the policy and concluded that extending the time between doses, changing the dose and mixing and matching vaccines are “reasonable questions” to consider and evaluate.

But in a strongly-worded statement it said that changing the vaccine schedule without evidence could “undermine the historic vaccination efforts to protect the population from COVID-19.”

There are concerns elsewhere that the extended dosing schedule could also lead to resistant forms of the virus taking hold at a time when there is a new and highly infectious variant spreading through the UK.

In the US, doctors pointed out that the slow roll-out of the vaccines is due to logistical challenges rather than supply and urged authorities to focus on this rather than delaying the dosing schedule.

In the meantime, the UK government has pushed ahead with plans to vaccinate everyone in the four highest-priority groups by mid-February.

This will require the NHS to start delivering at least two million shots a week from next week.

AZ’s chief executive Pascal Soriot said it would be possible to manufacture the required vaccines, although it remains to be seen whether output will be increased in time to hit the target.

The government said it already has a batch of 530,000 doses and a further 450,000 are reportedly due to be available by the end of week according to Oxford University’s regius professor of medicine Sir John Bell.

Several million more doses of the vaccine are understood to have been manufactured but have not yet been bottled in vials.

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Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Shots:

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Money Control

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Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Shots:

  • In the agreement, Aurobindo has obtained the exclusive rights to develop, manufacture & sell COVAXX’s UB-612 vaccine in India & UNICEF & also non-exclusive rights in other selected emerging & developing markets
  • UB-612 is presently being assessed in P-I will be manufactured by Aurobindo in its Hyderabad facility has a manufacturing capacity of 220M doses with an upcoming capacity of ~480M doses by June 2021
  • COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in P-I and plans to initiate P-II/II by Q1 2021 in Asia, Latin America, and the USA

Click here ­to­ read full press release/ article | Ref: PRNewswire  | Image: The Loadstar

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UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days.

If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian “Tier 4” restrictions due to the emergence of as more infectious variant.

Latest figures show that there were nearly 40,000 cases recorded yesterday, the highest since mass testing began, although it’s thought infection rates were higher during the first wave of the virus in spring when tests were not readily available.

The Medicines and Healthcare products Regulatory Agency (MHRA) began a fast-track rolling review of the vaccine in November and reports point towards a decision between Christmas and New Year.

The UK has ordered 100 million doses of the vaccine, which is based on an adenovirus vector and is easy to handle than rivals from Pfizer/BioNTech and Moderna.

AZ’s vaccine, dubbed AZD1222, is stored at normal refrigerator temperatures while the Pfizer/BioNTech and Moderna shots need to be kept at around -70C and -20C respectively to maintain the integrity of their RNA structure.

According to health secretary Matt Hancock, the full dossier of trial evidence is now with the regulator, which is poised to make a decision in the coming days.

AZ’s vaccine is safe and effective, according to the data publicly available so far, although it seems that giving a half-dose shot first following a second full dose is more effective.

Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

With two full doses, efficacy is around 62%, according to findings released towards the end of last month based on data from nearly 9,000 patients in the UK and Brazil.

Efficacy rose to around 90% in just over 2,700 patients given the low dose-high dose formulation, which was stumbled on by mistake because of a manufacturing error.

Quite what the MHRA will make of this is not clear, nor is it known whether the regulator has more up-to-date figures than those announced at the end of November.

Professor Sir John Bell, the government’s life sciences tsar and Regius Chair of Medicine at the University of Oxford, told BBC Radio 4’s Today programme yesterday:  “We are getting to be about prime time now.

“I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.

“And I have no concerns whatsoever, the data looks better than ever.”

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‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed.

Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot was independently backed by the UK’s regulator.

The variant has caused concern globally, prompting dozens of countries to close travel borders with the UK to prevent it from spreading.

There is no evidence to suggest the new strain causes more serious illness, but it does show variations in the “spike” protein that the virus uses to infect cells – the same protein that the Pfizer/BioNTech shot uses to confer immunity.

Sahin said: “We don’t know at the moment if our vaccine is also able to provide protection against this new variant.

“But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants.”

Proteins on the UK variant are 99% the same as on the prevailing strains and BioNTech has “scientific confidence” that the vaccine will be effective.

“But we will know it only if the experiment is done and we will need about two weeks from now to get the data,” Sahin said. “The likelihood that our vaccine works … is relatively high.”

It would take around six weeks to adjust the vaccine for the new variant in a worst-case scenario, although regulators would likely have to approve the changes before the vaccines could be used.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is reportedly close to a decision on a rival vaccine from Oxford University and AstraZeneca and may make a ruling in the coming days.

The MHRA begun a rolling review of the vaccine early in November, around the same time as it began to review Pfizer’s shot.

It is thought the review has been delayed by the range of results produced by the vaccine, after a manufacturing error led to the accidental discovery that an initial half dose of the two-shot vaccine seemed to produce stronger protection.

Feature image copyright BioNTech SE 2020, all rights reserved

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Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines.

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine.

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

The body produces antibodies against the protein, which neutralise the virus in the event of an infection.

It’s a revolutionary approach that allowed the vaccine to be made within a few days of the SARS-CoV-2 genetic code becoming available – what’s taken months are the rigorous clinical trials that proved the vaccines were safe and effective.

There has been considerable anxiety over whether using such an untried technology would be the best approach against COVID-19.

What the companies have now proved is that the technology can be used to make safe and effective vaccines in record time.

The companies are based on opposite sides of the Atlantic – Moderna was founded in Massachusetts in 2010 under the name ModeRNA Therapeutics by a team of investors two years after BioNTech began operating from a small lab in Mainz, Germany.

But both drew on the mRNA technology developed by Katalin Kariko from the University of Pennsylvania and her collaborator Drew Weissman, an immunologist from Boston University.

Together the pair had managed to find a way to get the human body to accept strands of mRNA without an immune reaction, by tinkering with the chemical make-up of the molecule.

It was a landmark discovery that meant a technology once derided as being a pipe dream could have applications in the real world as a medicinal therapy.

Moderna’s founders were led by Derrick Rossi, a post doctorate fellow from Stanford University who championed the technology to a team from Flagship Ventures, a Massachusetts firm founded and run by Noubar Afeyan.

CEO Stephane Bancel was hired the following year from France’s bioMerieux and Moderna went on to raise more than $2.6 billion in a series of private funding rounds, while fiercely guarding any details about the technology it was developing.

This changed in 2018 when Moderna went public with what was at that time the largest IPO in biotech history.

The launch raised $500m from investors using what is arguably the slickest stock market ticker out there – MRNA.

Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine.

“I was intrigued by the personalities of the founders. They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

While Moderna blazed its investment trail and tried to find ways to make sure its mRNA vaccines did not produce dangerous immune reactions, a small biotech called BioNTech had licensed in the technology from Kariko and Weissman.

Run by husband-and-wife team Ugur Sahin and his wife Ozlem Tureci, BioNTech wanted to use the technology to create individualised cancer therapies.

Matthias Kromayer, a general partner at the German investment fund MIG that helped found BioNTech in 2008, said he first met the pair 15 years ago and was immediately intrigued.

He told pharmaphorum: “They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

The company began to strike several deals with big pharma companies to develop cancer drugs and in 2013 hired Kariko, who had spent years working on mRNA at Penn, to oversee the mRNA work as senior vice president.

Fast-forward to the beginning of 2020 and the companies realised that they would have to quickly change their research priorities to vaccine development as the coronavirus pandemic began to emerge in China.

Kromayer said the risks and opportunities to take on the coronavirus vaccine challenge were huge for BioNTech, which only went public on the Nasdaq at the end of 2019.

He said: “It was a risk – if (the vaccine) had failed it would have shed negative light on mRNA tech. But it was a once in a lifetime opportunity.”

But according to Kromayer the BioNTech team were confident that mRNA was the solution to the coronavirus problem, as mRNA sequences can be generated in such a short amount of time.

“You can manufacture mRNA vaccine overnight and still it is stable,” said Kromayer.

The rest is history – Pfizer stepped in and licensed the technology, choosing the most promising of four potential mRNA vaccines from BioNTech.

Both Moderna and Pfizer’s shots aced the quickly convened clinical trials and became the first vaccines to make it to market less than a year after the pandemic began.

Thanks to the innovation there are hopes that peoples’ lives may return to normal as 2021 progresses but according to Kromayer this is just the tip of the iceberg for mRNA therapeutics.

The founders of both Moderna and BioNTech realised early on that this is far more than just a vaccine and could be used to tackle diseases that have proved impossible to tackle with the previous generations of medical technology.

Rossi, who left Moderna in 2014 had initially thought it could be used to reprogramme cells to act like stem cells but realised its potential after a bruising encounter with Robert Langer, the legendary MIT scientist and entrepreneur.

According to Kromayer potential uses include pre-emptive vaccines for diseases such as Parkinson’s as well as to create personalised cancer therapies.

Kromayer concluded: “The message is that mRNA based medicines are not just here to serve as vaccines it is much, much, more. This will revolutionise medicine over the next 10-15 years in areas we do not even imagine.”

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NHS pilots virtual assistant for flu jab bookings

More than 1,000 NHS patients have booked flu vaccinations using a virtual assistant as part of a pilot project in the south east of England.

The pilot project, run in collaboration with GP practices in Buckinghamshire, Brent, and Greenwich, involved patients using the Ask NHS app, which is already used by more than 375,000 patients.

Patients in the pilot used the app developed by Sensely to self-check eligibility and quickly make appointments for flu jabs.

Launched in 2017, the free-to-use Ask NHS app lets users easily check symptoms, book clinician appointments, access self-care resources, and connect with live video consultations.

The app uses Natural Language Processing (NLP) and speech recognition technologies make the conversational interface easy to use, while freeing up doctors and nurses’ time.

Citing post-usage survey data, Sensely claims the app can reduce per-patient costs by as much as 14.4%.

Adding vaccination information, a self-service eligibility check, and booking functionality to Ask NHS lets patients, protect themselves and loved ones, quickly get the information they need and make appointments without having to call their clinic.

Designed in partnership with NHS nurses, the tool also allows high-risk patients to be prioritised based on symptoms or underlying health issues, improving access to vaccinations for vulnerable patients while easing the strain on healthcare providers.

The project sets the stage for the more widespread use of virtual assistants as the UK begins to roll out COVID-19 vaccines.

Sensely is currently developing COVID-specific virtual tools and plans to begin supporting NHS coronavirus vaccination efforts with customised virtual assistant technologies in early 2021.

Sensely CEO Adam Odessky said: “During the pandemic, more people than ever are getting flu shots — but that places an enormous strain on clinics, and those challenges will only increase as we roll out COVID-19 vaccines.

“Our top priority, now and always, is to support the NHS and ensure patients get vaccinations quickly and easily. By using next-gen digital tools as part of an omnichannel strategy, we’re empowering patients to take ownership of their healthcare journey, and protect their families while easing the burden on hardworking doctors and nurses.”

The app is available on iOS and Android smartphones.

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FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts.

Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against the advice of its experts after such strong backing.

The vaccine was also given a glowing review by FDA staffers in a briefing document posted ahead of the meeting and looks set to become the second COVID-19 vaccine to hit the US market after Pfizer/BioNTech’s rival was approved last week.

Pfizer’s vaccine was approved within a day of a positive vote from the Vaccines and Related Biological Products Advisory Committee.

Roll-out of the Pfizer vaccine has already begun and FDA commissioner Stephen Hahn said the agency will work “rapidly” towards issuing an Emergency Use Authorization for Moderna’s shot.

The US has agreed to buy 200 million doses and there are six million doses ready move to ship as soon as the vaccine is officially approved.

Yesterday’s panel vote heard that the vaccine worked in 94% of cases, based on clinical data gathered so far, and is safe.

It is also slightly easier to move around – although it is an mRNA-based shot like Pfizer the storage temperature is around -20C, considerably less demanding than temperatures of around -75C required to maintain the integrity of its already-approved rival.

Moderna’s vaccine is also given in two shots, with the injections four weeks apart compared with the three-week interval required for Pfizer’s.

The UK has also pre-ordered seven million doses of the Moderna vaccine, which is also being reviewed by the country’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA).

Canada also plans to get two million doses by March, part of a total 56 million doses ordered from Moderna.

The European Union has also announced a contract to buy 80 million doses and an option to buy 80 million more once the vaccine is formally approved.

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Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Pharmaphorum

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COVID-19 vaccine distribution: 4 ways providers can win with online self-scheduling

It’s been almost an entire year since COVID-19 changed life as we know it. The good news? A vaccine has finally arrived and is currently making its way to distribution sites across the United States—a significant milestone as the nation has seen more than 16 million cases to date, and more that 300,000 deaths.

Because of the current supply, the Centers for Disease Control are recommending healthcare personnel and residents of long-term care facilities receive the vaccine first. Supply is expected to increase in the weeks and months to come, however, and the goal is for everyone to have access to a vaccine by the second quarter of 2021.

As healthcare organizations across the country prepare to meet the vaccine demand, it is expected the logistics and distribution management will add pressure to staff and services already under stress. The challenge: administer the vaccine as efficiently and safely as possible.

Online patient scheduling has already been a game changer during the pandemic, but its potential as a traffic management tool to address the influx of vaccine appointment requests is even greater—and not just for patients. In the early stages of deployment, online self-scheduling can be a game changer for healthcare workers and other essential employees looking to schedule and receive the vaccine.

Here are four ways providers can leverage online patient self-scheduling for the rollout of the COVID-19 vaccine:

Designate day and time slots specifically for administering vaccines

By incorporating providers’ scheduling rules into the scheduling process, there is the opportunity to designate specific day and time slots for administering the vaccine.

It not only makes it easy for patients to schedule, but it additionally allows both patients and providers to further minimize the risk of unnecessary contact with others in the office.

Create screening questionnaires during patient scheduling

As more patients go on-site for the vaccine, they must be routed to the most appropriate care source and location. This will prevent unnecessary traffic and bottlenecks in the office, while ensuring the safety of individuals.

As soon as a patient begins to book a vaccine appointment a few short questions about their symptoms and reason for booking can be presented. A screening questionnaire like this can triage people wanting to get a vaccine or get tested, and help identify potential COVID-19 positive individuals, and if that individual needs to quarantine prior to coming in for the vaccine. After screening, the system can direct patients through the correct channel of care.

Screening questionnaires can also be used to determine if a patient is eligible for the vaccine given the current status of vaccine deployment. Older patients may be given priority whereas younger patients may be told to schedule at a later date.

A system like this can also reduce pressure on call center staff and give providers control over the volume and timing of in-person appointments, thus helping to reduce patient and staff exposure to any contagion.

Make it as easy as possible for patients to schedule both doses

Most of the early COVID-19 vaccines will require shots to be effective, with the second dose being administered 21 to 28 days after the first. It’s critical that the second does is administered in a timely manner. There are a few ways to encourage patients to return.

First, providers can help patients book their follow-up appointment in the office before leaving.

Second, providers can leverage automated outreach as a method to contact and remind patients to book a follow-up. Experian Health’s Patient Outreach Solutions have been purpose built to meet this need, sending outreach campaigns to individuals enabling them to self-schedule needed care conveniently, right from a text or voice message.

Automated outreach would allow providers to reach out to specific subsets of patients that may require or benefit from the vaccine early on, like older individuals or those with chronic conditions. With it, providers have the ability to reach out to hundreds, even thousands of patients without manual call center workload – something that will come in handy as now the majority of Americans plan to get vaccinated for the coronavirus.

Improve the efficiency of drive-through vaccination programs

For those providers considering drive-through vaccinations (similar to drive-through COVID testing), online scheduling makes a huge difference—not only for booking an appointment, but for preventing bottlenecks as patients arrive. Detailed information such as the patient’s vehicle model, color and license plate number can all be recorded ahead of time during the screening process, allowing providers to quickly identify patients as they arrive.

Learn more about the benefits of digital scheduling and how Experian Health can help your organization navigate the rollout of the COVID-19 vaccine.

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Trials of Valneva COVID-19 vaccine begin in UK

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech.

France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

It is the first publicly announced inactivated COVID-19 vaccine candidate to begin clinical development in Europe.

The vaccine is based of inactivated viruses grown in culture and includes an adjuvant used to boost the immune response.

Primary endpoint read-out will be two weeks of completion of the immunisation given in two doses, 21 days apart.

Valneva plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval in the fourth quarter of 2021.

But the two-dose schedule being used by many of the vaccines is proving to be a stumbling block as the shot is rolled out across the UK.

It’s vital to track who received the vaccine and when, so they can be called in for the second booster shot at the right time.

But according to Sky News GP practices have been forced to collect data on the rollout of the vaccine shot by hand.

This follows problems with the software being used to keep track of who has been given the jab.

Citing a senior health official, Sky said that the IT system used was “failing constantly” and that GPs were “having to record on paper and then transfer”.

Vaccine minister Nadhim Zahawi tweeted what the Department for Health Social Care described as “provisional figures” on how many people had received the vaccine on Wednesday morning.

The official said GPs were not able to find out who had already been vaccinated by a hospital, causing delays as checks were made and raising the risk people might get missed, or even vaccinated twice.

In the US, advisers to the FDA are to meet later today in a vote that will inform whether Moderna’s rival vaccine should get an Emergency Use Authorization.

The vote from the Vaccines ands Related Biological Products Advisory Committee is non-binding but the FDA usually follows the advice of its experts.

FDA staffers have already given the vaccine a glowing review ahead of the meeting.

According to the World Health Organization, there are 52 candidate vaccines in clinical development, and 13 have made it through to phase 3 trials.

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Minervax raises €47.4m in Series B funding round for GBS shot

Denmark’s MinervaX has raised €47.4 million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials.

When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains resistant to existing antibacterial medicines.

MinervaX is one company that wants to change this situation, which aims to prevent the spread of GBS infections using a vaccine instead of using an antibacterial agent.

On the back of phase 1b data the Copenhagen-based biotech said it had brought in new investors Sanofi Ventures, Adjuvant Capital and Industrifonden along with existing investors Novo Holdings, REPAIR Impact, Sunstone Life Science Ventures and LF Investment.

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

GBS is responsible for nearly half of all life-threatening infections in newborns. MinervaX’s protein-only GBS vaccine targets pregnant women for the prevention of adverse pregnancy outcomes and life-threatening neonatal infections associated with GBS.

Globally, 15-25% of women are colonised with GBS, and they run the risk of transmitting the bacteria to their child in utero, during birth and / or during their first months of life.

GBS colonisation may lead to late-term abortions, premature delivery or stillbirth; and in newborn children may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death.

The only preventive strategy available involves using intravenously delivered antibiotics and this does not comprehensively prevent infection in utero or reliably protect against late-onset infection in newborns.

Phase 1 data from 300 healthy females have so far shown a favourable safety profile, while generating high levels of long-lasting antibodies.

These are capable of mobilising the immune system against GBS bacteria and preventing invasion of epithelial and endothelial cell barriers.

Work began on a potential streptococcus vaccine in the 1980s and in 1996 a phase 1 trial provided a proof of concept that using polysaccharides and antigens from GBS could provide a strong enough immune response.

But there have been no GBS vaccines licensed since then, the Lancet pointed out in an editorial earlier this year.

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Family doctors begin COVID-19 immunisation drive in UK

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot.

In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today.

Some clinics will begin immunisations this afternoon and the majority will start tomorrow (Tuesday), the NHS said.

The vaccine, which was approved in the UK earlier this month, will be administered by teams of nurses, paramedics and pharmacists.

Those aged over 80, as well as care home workers and residents, will get the vaccine first as they are considered to be in the group at highest risk of getting the disease.

Care home residents will start to receive the vaccine later this week as distributors finalise the processes to deliver the Pfizer/BioNTech vaccine, which must be stored at around -70c to maintain its integrity.

Practice teams are redesigning sites to put in processes to meet these logistical challenges and the NHS will contact people in the priority groups when it is their turn to receive the vaccine.

Dr Simon Hodes, a GP from Watford told the BBC that his surgery is due to begin vaccinations on Monday, adding that very few of his patients had worries about the shot.

Hodes said his surgery had introduced a “military-style operation” to ensure vaccine doses are not wasted.

Dr Nikki Kanani, a practising GP and NHS director of primary care, said: “GPs, nurses, pharmacists and other primary care staff are eager to play their part in protecting people against coronavirus.

“This is the greatest vaccination programme ever undertaken by the NHS and, to help vaccinate people safely we will be working with local communities to deliver it in convenient and familiar settings.

“As a GP I am proud to be part of this huge national effort to protect our patients against the virus and I would urge the public to come forward when they are called up for the vaccine.”

Feature image copyright BioNTech SE 2020, all rights reserved

 

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Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults.

While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.

This was likely due to an insufficient concentration of the antigen, according to a team of analysts from Jefferies investment bank, who said the companies have decided to investigate an improved formulation.

This demonstrated rapid viral clearance in a challenge study in non-human primates.

A phase 2b study is expected in February next year with support from the US government agency, the Biomedical Advanced Research and Development Agency (BARDA).

This could lead to a phase 3 study next summer and an authorised product at the end of next year delaying deliveries of potentially more than a billion shots, enough to protect half a billion people.

The US government has an agreement to buy 100 million doses, with an option for another 500 million doses and has funded development to the tune of $2.1 billion.

The European Commission has an agreement for 300 million doses, the UK has ordered 60 million doses and the Canadian government has ordered 72 million doses.

AZ to combine vaccine with Russian rival

In a separate development it has emerged that AstraZeneca is to test its whether its COVID-19 vaccine can be combined with a component used in Russia’s Sputnik V shot, according to a statement the government-backed Russian Direct Investment Fund (RDIF).

Clinical trials so far have shown that Sputnik V, which uses two different types of viral vector to produce an immune response, provides protection in around 90% of cases.

The RDIF, which has helped bankroll the vaccine, said AZ had accepted a proposal to begin trials of its AZD-1222 in combination with Sputnik V’s human adenoviral vector type Ad26 by the end of the year.

AZ has already announced findings suggesting that using an initial lower dose of the vaccine produces a protection level of around 90%, while using two maximum strength doses produced protection levels of just over 60%.

The idea behind Sputnik V, developed by a team of scientists from Moscow’s Gamaleya Center, is to use two shots using different viral vectors to reduce the risk of the body developing resistance and not producing a boosted immune response to the second booster shot.

AZ’s vaccine, developed in partnership with Oxford University, looked like one of the most promising vaccine candidates until it was hit with a safety scare that caused trials to be put on hold for a few weeks in September.

While regulators later decided that trials could continue, the announcement that researchers had accidentally stumbled on the low-dose high-dose combination did not go down well and caused the company’s share price to tumble.

 

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FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot

Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee.

While the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is non-binding, the FDA seldom goes against the ruling of its advisers when making regulatory decisions.

However has were some concerns raised, reflected in the 17 to 4 vote in favour of approval.

Some experts in the public meeting were concerned about the short length of the human trial so far as well as the potential side-effects for people with allergies or pregnant women.

Already approved in the UK, this is the first time that mRNA technology has been used to create a vaccine.

There were also concerns about whether the vaccine should be used in 16-17 year-olds because of a lack of safety data in this group, balanced against the fact people from this age group are unlikely to fall seriously ill.

The committee also considered two cases of allergic reactions seen in the UK this week and has asked Pfizer to monitor for severe allergic reactions.

This may lead to further advice on the label of the vaccine if the FDA decides to go ahead with the Emergency Use Authorization that Pfizer is asking for.

The phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.

Pfizer pointed out that the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.

Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety.

 

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QliqSOFT, CPSI to offer Covid-19 vaccine chatbot to community hospitals

The COVID-19 Vaccination Assistant will provide information about the new vaccines to help allay fears among the U.S. public. It will also help people schedule their vaccinations and connect them with rideshare services to make it to their appointment.

Coronavirus vaccine may have allergy warning in US, says expert

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions.

Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies to avoid the vaccine.

According to press reports, Slaoui expects an influential FDA advisory committee to say today that people with severe allergies “should not take the vaccine until we know exactly what happened.”

According to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), people with a “significant history of allergic reactions” should avoid the shot.

This followed two NHS staff members, who both carried adrenaline auto-injectors and had a history of allergic reaction, developing an anaphylactoid reaction after receiving the vaccine on Tuesday.

These individuals developed symptoms of anaphylactoid reaction – a milder reaction than a severe anaphylactic shock – shortly after receiving the vaccine. Both recovered after appropriate treatment.

Professor Stephen Powis, national medical director for the NHS, said in a statement: “As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”

It’s an issue that’s also likely to come up at today’s meeting of US vaccine experts, who are advising the FDA on whether to go ahead with an Emergency Use Authorization for the shot.

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

The committee will meet in public to discuss the shot and although the FDA is not bound to follow its advice, the regulator usually follows its experts’ advice when making decisions on drugs.

The regulator has run its own analysis of the vaccine and concluded there was a “slight numerical imbalance”, with more adverse events representing allergic reactions in those taking the vaccine compared with the placebo group.

There were 137 people reporting hypersensitivity-related adverse events in the vaccine group and 111 in the placebo group, according to the analysis in the briefing document.

This represented a tiny fraction of the 38,000 people tested in the phase 3 trial at the time of data read-out although the trials so far have excluded people with histories of allergic reactions.

Feature image copyright BioNTech SE 2020, all rights reserved

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CO2 Safety Monitors for Dry Ice Vaccination

Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release of CO2 when dry ice sublimates. The chain needed more than 800 safety monitors to be distributed to the first vaccine administration facilities on short notice. CO2Meter provided the chain with a CO2 safety monitor that is easy to install and that will detect the gas even

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading.

The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go.

But there are still unanswered questions that can only be addressed once the shot is administered to the wider public.

Thursday’s vote of the Vaccines and Related Biological Products Advisory Committee is non-binding – but the FDA seldom takes a different viewpoint from its experts when it makes a final regulatory decision.

Pfizer and BioNTech are asking for an Emergency Use Authorization of their vaccine based on phase 3 data, which can be converted into a full licence at a later date once further trial information is published.

Phase 3 trials are designed to test whether vaccines are safe and effective and in this regard FDA reviewers said in the document that the Pfizer/BioNTech vaccine is a success, effective in around 95% of cases and with “favourable safety profile”.

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

There were four cases of Bell’s palsy – a sudden muscle weakness – in the vaccine group and none in a placebo arm.

However the FDA noted there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating women, and those with compromised immune systems.

The biggest issue for the FDA staffers is one that will only be resolved with time – whether or not the shot can prevent people from infecting each other.

Reviewers said that “additional evaluations including data from clinical trials and from vaccine use post-authorisation will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection”.

Reviewers noted there was no evidence of “vaccine-enhanced disease” but whether the vaccine could lead to a more resistant strain of the virus emerging is also unclear.

The regulator will be keeping a watching brief on this as more study data emerges over the course of the pandemic.

This risk “needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorisation and/or licensure,” reviewers said.

Hospitals in the UK have already begun immunising high-risk patients after the country’s regulator became the first in the world to approve the Pfizer/BioNTech vaccine last week.

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Sinovac raises $515m to boost production of potential COVID-19 vaccine

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion.

According to press reports Sino Biopharmaceutical, a Hong Kong-listed generics firm, acquired a 15% stake in a subsidiary of Sinovac.

Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

Also in late-stage development in China are two other candidates developed by state-run Sinopharm.

The company plans to manufacture 300 million doses of the vaccine annually, but capacity will double after a second facility scheduled for construction by the end of the year begins operation.

All the vaccines developed in China are inactivated, meaning they are made of proteins found on the surface of the coronavirus that produce a response that provides immunity in the event of an infection.

This means they do not require the ultra-cool temperatures needed to store the RNA-based vaccines from Pfizer/BioNTech and Moderna.

Sinovac has already made large shipments, according to the Financial Times, in preparation for announcement of phase 3 results.

It is also distributing its vaccine within China as part of a large-scale emergency use programme.

According to the state-run Indonesian news agency Antara, 1.2 million doses were delivered to Indonesia on Sunday.

A further 1.8 million doses are expected to arrive in early January according to president Joko Widodo, who added that the country’s drugs regulator is already reviewing data from clinical trials.

Yin Weidong, Sinovac’s chief executive, reportedly said the investment will enable the company to “improve vaccine sales capabilities (and) expand in Asia markets”.

According to latest information from the World Health Organization, there are 51 vaccine candidates in clinical development.

There are more than a dozen in late stages of clinical development and the UK last week became the first country to approve the coronavirus vaccine from Pfizer/BioNTech.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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UK faces “V-Day” and largest ever vaccination programme

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial.

Health secretary reportedly Matt Hancock came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

The UK last week became the first country in the world to officially authorise the vaccine, which has so far shown an effectiveness of around 95% and minimal side effects in a late-stage clinical trial.

But the logistics of delivering the vaccine are hugely challenging, with up to 4 million sent out this month alone.

The most at-risk groups of people will be first to get the vaccine, with people in care homes, those aged over 80 and healthcare workers targeted first.

On top of this is the requirement for the cutting-edge RNA-based vaccines to be stored at ultra-low temperatures.

According to Luxembourg-based cold chain specialist B Medical Systems, demand for ultra-cool freezers has gone “off the chart” in recent weeks.

Pfizer’s vaccine needs to be stored at around -70C to retain its integrity, while its rival from Moderna that is under review by regulators needs to be stored at -20C.

The company has developed a product that can operate as both a vaccine freezer and a vaccine refrigerator, which could be used to store the Pfizer/BioNTech and Moderna vaccines, as well as the potential shot from AstraZeneca that requires standard refrigerator temperatures for storage.

However the waiting list for the vaccine fridges is expected to grow as more and more companies authorise various coronavirus vaccines.

CEO Luc Provost said: “Normally we would be supplying 2,000-3,000 units typically for a country. We expect this to increase 5-7 fold to some 15,000 units at least. In places like India we are seeing orders reach six figures.”

The biggest challenge is maintaining an unbroken “cold chain”, something that is already common in medicine logistics, but more challenging on this occasion because of the specialist requirements of the vaccine and the sheer scale of the operation.

According to Provost the biggest challenge will be distribution within the UK and other countries and in particular “the last mile” to the patient.

“Vaccine wastage happens in two areas – in-country transport and vaccine administration at health facilities.

“Most portable vaccine carriers and cold containers cannot keep cold beyond 12 hours, especially if it is hot outside.

“Transportation for the last mile to where the immunisation is happening – for example care home residents which will be amongst the first in the UK to get vaccinated – is time consuming and monitoring this journey presents a big problem.”

Feature image copyright BioNTech SE 2020, all rights reserved

 

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Valneva accelerates Lyme disease vaccine R&D project with Pfizer

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021.

Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

They will receive VLA15 at the dose of 180 micrograms, which was selected based on data from two ongoing phase 2 studies.

First data from the study is expected by the second quarter of 2022 and all three studies will support a phase 3 pivotal efficacy trial including all main target populations for the Lyme vaccine, starting in 2022.

Starting the next phase 2 study will trigger a milestone payment from Pfizer to Valneva of $10 million under a collaboration announced in April this year.

Under the agreement Valneva could receive up to $308 million in cash payments, after Pfizer paid $130 million up front for marketing rights to the vaccine if it succeeds in the clinic.

Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development.

VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six strains that are prevalent in North America and Europe.

This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of the bacterium Borrelia that causes the disease, an established mechanism of action for a Lyme disease vaccine.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in the ticks that spread the disease.

VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

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Pfizer cut vaccine production targets because of raw material shortage – reports

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports.

The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

A Pfizer spokesperson told Reuters that the “scale-up of the raw material supply chain took longer than expected”.

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added.

Modifications to Pfizer’s production lines are complete and finished doses are being made at a rapid pace.

The Wall Street Journal reported the news first, quoting an unnamed source directly involved in the development that some early batches of raw materials had failed to meet standards, causing production delays.

The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator.

Pfizer has asked the FDA for an emergency authorisation of the vaccine in the US and the US government expects to the first tranche to include about 6.4 million doses.

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021.

Of those 85-100 million will be available in the US and 15-25 million will be available outside the US.

The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Moderna’s vaccine is also under review by regulators including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UK has secured 7 million doses of Moderna’s vaccine after upping its order by 2 million earlier this week.

This could mean the UK could have access to up to 357 million doses of vaccines from seven different developers if they are all approved by regulators.

There are now more than 50 vaccines in clinical development and more than a dozen in late-stage trials, according to a regularly updated document from the World Health Organization.

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The known unknowns of COVID-19 vaccines

News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain.

“There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech and, more recently, the University of Oxford/AstraZeneca. All three show promise, but not have shared their full data, instead issuing a series of press releases.

The biggest unknowns are whether these results will hold up once full study findings are published and if a similar level of protection can be expected for other COVID-19 vaccines coming down the pipeline. The results could also change once these vaccines are rolled out on a population scale. We know that these vaccines work in clinical trials but we won’t know if their effectiveness will be the same in real-world scenarios.

“There’s no way that we can see that without a vaccine being licenced,” said Sundaram.

Although the trials included a diverse group of participants, including older adults and those from racial-ethnic minorities, it’s hard to know whether these findings will be generalizable to a broad range of people once the vaccines become available, experts say. For example, there is no information about how well this vaccine works in children. All three trials reported early results only in adults over the age of 18.

In addition, we don’t know if the vaccines prevent asymptomatic transmission.

“That’s something that is often an issue when designing vaccines for respiratory viruses that are administered intramuscularly,” according to Alyson Kelvin, a virologist with the Canadian Centre for Vaccinology at Dalhousie University who has recently been seconded to work on COVID-19 vaccines. “When we give a vaccine in your arm, it’s often hard to get mucosal immunity in the upper respiratory tract,” like your nose, which is needed to stop transmission. A key for effective policy, she says, will be knowing whether someone who is vaccinated is still able to transmit the virus.

Also unknown is how well the vaccines will work in people who have already had COVID-19. All three studies excluded people with prior COVID-19 infection, although Pfizer/BioNTech and Oxford/AstraZeneca plan to look at this in a separate analysis.

As with all new vaccines, the length of protection has yet to be determined, since all three trials only began enrolling participants this summer. The companies have not disclosed how long participants were observed or whether any violated the study rules, which could change the initial efficacy estimates.

“Right now, we only have the interim data,” said Kelvin. We won’t know their long-term safety profile or whether they might cause rare side effects until after the vaccines are deployed to the public, although no safety issues have been identified to date.

“They seem to have a really positive safety profile. I haven’t seen anything that I am initially concerned with,” says Kelvin.

Protection could also be lower if people don’t adhere to the vaccine schedule. All three vaccines require two doses spaced at least three or four weeks apart.

“I think one really important question is: are people going to come back in for a second dose?” asks Sundaram. She says this might be an issue particularly if the first dose causes adverse reactions like a headache or fever.

Vaccine side effects may make people more hesitant to get vaccinated in the first place. In a StatsCan survey conducted before the recent vaccine announcements, about one in seven Canadians said they were unlikely to get a COVID-19 vaccine, citing a lack of confidence in safety and concerns about its side effects.

What about other COVID-19 vaccines in development?

All three vaccines reporting early results use newer technologies that deliver genetic material from the SARS-CoV-2 virus – either alone through what’s call messenger RNA (or mRNA, used by Pfizer/BioNTech and Moderna) or contained inside another virus or “vector” that can’t replicate on its own (Oxford/AstraZeneca). They then hijack the body’s own cells to make copies of the viral spike protein, the crown-like molecule protruding from the surface of the SARS-CoV-2 virus.

These types of vaccines have never been licenced before for use in humans.

Nine other COVID-19 vaccines are currently in late-stage trials, including four that rely on more conventional vaccine models using an inactivated (or killed) virus. These vaccines may elicit a more robust immune response that targets other viral components, not just the spike protein. They also may be better tolerated than some of the mRNA or viral vector vaccines based on earlier trial results.

Four are non-replicating viral vectors like the Oxford/AstraZeneca vaccine. These types of vaccines could have lower vaccine efficacy if people have pre-existing immunity to the vector. (Oxford/AstraZeneca tries to get around this by using a chimpanzee adenovirus, rather than a human one, as their vector.)

Others, like Novavax’s protein subunit vaccine, may be better able to generate a protective antibody response in the upper respiratory tract, which is important for blocking transmission, says Kelvin, whose lab is also developing a COVID-19 subunit vaccine.

Because they use different ways to trick the body’s immune system to produce antibodies, scientists can’t say whether these vaccines will be able to replicate the 90 to 95 per cent efficacy seen in the early trials.

“I don’t know what to expect. I’ll be honest with you,” states Sundaram. “I think it’s hard to use the results from these (three) studies to extrapolate to the other ones, especially for the other vaccine types.”

The number of doses, vaccination schedules and route of administration could also affect vaccine efficacy – along with patient factors such as age, underlying conditions and pre-existing immunity and viral factors such as genetic mutation. Experts say the latter is of less concern since SARS-CoV-2 doesn’t mutate as much as other RNA viruses, like influenza.

Looking ahead

While much remains unknown about these vaccines, these early results exceed the expectations of most scientists and bode well for other COVID-19 vaccines in development. Recently, Health Canada announced it would license a COVID-19 vaccine if it met a threshold of at least 50-per-cent efficacy.

The true impact of these new COVID-19 vaccines on curbing the pandemic will depend both on their efficacy but also their uptake on a population scale.

Given potential delays in vaccine manufacturing and rollout, a COVID-19 vaccine will likely not be enough to end the pandemic. But it will be another tool in our public health toolbox, alongside physical distancing, contact tracing and community supports, says Sundaram.

“As always, there’s more work to be done and further questions to be asked in Phase 4 studies,” says Sundaram. “But this is exactly the sort of direction that we would have hoped things would go. So, I’m very happy about that.”

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Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it.

As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of the data.

Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

The companies said they will take immediate action to begin delivery of the vaccine and the first doses are expected to arrive in the country over the coming days, with the entire tranche expected to be complete next year.

Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

There are 11 groups, with older adults living in care homes and care home workers in the first group and those aged 80 years of age and older and health and social care workers second on the list

Delivery will begin throughout 2020 and 2021 to ensure fair allocation of the vaccines across different areas.

Another issue will be the logistical challenges of storing the RNA-based vaccine at around -70C and sending it out to clinics and GP surgeries across the country.

Danny Mortimer, chief executive of the NHS Confederation, which represents organisations across the healthcare sector, said there are still questions that need to be ironed out to support the delivery process.

Mortimer said: “This is the starting klaxon for people readying to deliver the vaccine. What’s ahead will be a marathon and not a sprint, with many months ahead to vaccinate everyone who needs it.

“This welcome news, however, does not mean that we are immediately out of the woods.

“Our already-stretched NHS faces a monumental effort now to roll-out the vaccine quickly and effectively.”

Nevertheless the UK health secretary Matt Hancock tweeted that “help is on its way” after the announcement.

Earlier this month the UK became the first country in Europe to pass 50,000 deaths from the coronavirus.

Transmission rates have fallen in the last month but only because of another economically crippling national lockdown, which has cost thousands of people their livelihoods as businesses struggled to survive.

Pfizer’s CEO Albert Bourla said: “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

The MHRA is not the first national regulator to approve a coronavirus vaccine – that accolade goes to the Russian regulator, which backed the “Sputnik V” vaccine developed independently by a team in Moscow.

But this is the first approval based on phase 3 data as the Russian vaccine was only licensed on an interim basis after a review of earlier clinical data.

Other regulators are also reviewing the Pfizer/BioNTech vaccine, including the FDA, and the MHRA is also reviewing data rivals from Moderna and AstraZeneca/Oxford University.

Feature image © BioNTech SE 2020, all rights reserved

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Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year.

The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

If the EMA decided that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend a conditional marketing authorisation that could enable use of the vaccine in Europe by the end of 2020.

The data submitted show a vaccine efficacy rate of 95% in the companies’ phase 3 clinical study, which involved patients without previous infection with the SARS-CoV-2 infection and also people with and without previous infection.

Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%, the companies said.

The first primary objective analysis was based on 170 confirmed cases of COVID-19. In the trial, BNT162b2 also showed an overall favourable tolerability with no safety concerns reported to date.

Approximately 42% of global participants and 30% of US participants in the phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age, the companies noted.

The FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have already begun their reviews and similar rolling submissions have begun in countries including Australia, Canada and Japan.

Despite the fast review, the company insisted that the potential vaccine will be assessed according to the EMA’s normal standards for quality and safety.

The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

If approved these vaccines will break new ground as it will be the first time RNA vaccines have been used.

They work by using a short length of genetic code that makes the body produce the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus.

This encourages the body to produce antibodies that neutralise the virus in the event of an infection.

 

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Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Shots:

  • The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date
  • Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
  • The FDA has told Company to expect VRBPAC meeting for mRNA-1273 on Dec 17, 2020. The Company will submit data from the P-III COVE study to a peer-reviewed publication

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Fox Business

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Vaccine nationalism, CDMO expansion, AMR and dual sourcing predicted in 2021

The new report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge Amsterdam:  A new report from CPhI explores the potential implications in 2021 of impending vaccine approvals, a new administration in the White House and a return to dual supply chain strategies. The report – which summarises expert analysis into 12 key findings – foresees a particularly positive outlook for the pharma manufacturing supply chain, as a result of the demand for increased second source contingencies, alongside the huge scale-up of vaccine capacity currently underway. A consequence of which is

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UK appoints COVID-19 vaccine rollout minister as country preps for launch

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine.

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine.

According to the Financial Times, the MHRA could approve the vaccine by 7th December after the companies announced supportive data from a phase 3 trial mid-way through November.

Nadhim Zahawi

Zahawi will therefore face the difficult task of overseeing distribution arrangements for the shot, which must be stored at around -70c during transit to retain its integrity.

A minister for business and industry, Zahari will temporarily relinquish responsibility for most of his duties at the Department for Business, Energy and Industrial Strategy (BEIS).

The interim arrangement will see the MP for Stratford-on-Avon serve as a joint minister between the BEIS and the Department for Health and Social Care.

The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

The UK has ordered 40 million doses of the two-shot product, which could be up to 95% effective in preventing diseases, according to the companies’ top-line data.

Although the European Medicines Agency technically has authority to authorise medicines for the UK until December 31 under Brexit transition arrangements, the MHRA can temporarily authorise products in cases of urgent need.

The government has also written to the MHRA, asking it to use the same process to authorise the rival vaccine from AstraZeneca and Oxford University.

As reported by pharmaphorum, the MHRA’s forthcoming spilt from the EMA could potentially allow it to be more agile in its decision-making after Brexit.

Emergency approval is also expected in the US next week, the FT added, with shipments starting across the country within 24 hours of the announcement.

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Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots:

  • Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273
  • The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M doses/yr & possibly ~1B doses/yr, beginning in 2021
  • The company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside the US. Additionally, Moderna reported that the vaccine showed 94.5% efficacy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

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AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review

AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data.

The shot, known as AZD-1222, developed in partnership with Oxford University, has dominated the pharma news agenda this week after it hit efficacy targets but appeared short of rivals from Pfizer and BioNTech.

With an overall efficacy of 72%, below the 95% seen with rivals, AZ’s vaccine would have been even weaker had it not been for a stronger potency seen in patients accidentally treated with a half dose followed by a full dose.

Now CEO Pascal Soriot wants to conduct a new test to confirm the 90% efficacy rate of the lower dose regimen, which was stumbled upon because of a manufacturing mistake.

The companies did not disclose the error at the time and there are concerns over their transparency, Bloomberg news reported.

Soriot told Bloomberg: “Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study.”

This will likely be another international study but could be faster as it will require fewer patients due to the higher efficacy seen with the revised dosing regimen.

The additional trial is unlikely to hold up regulatory approvals in the UK and EU, according to Soriot.

Health secretary Matt Hancock has asked the UK’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA) to begin its review of the vaccine.

The Department of Health and Social Care said the UK could be one of the first in the world to receive the vaccine if authorised.

AZ is set to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March.

The government also has pre-ordered 40 million doses of the Pfizer/BioNTech vaccine, which could be more than 90% effective but is harder to store and distribute as it needs to be kept extremely cold to retain its integrity.

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Brexit could hinder access to coronavirus vaccines, says pharma group

The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other measures in this week’s spending review aimed at reviving the economy after the pandemic.

In the build-up to chancellor Rishi Sunak’s announcement in the House of Commons, the Association of the British Pharmaceutical Industry (ABPI) chief executive Richard Torbett warned that a no-deal Brexit could disrupt supplies of vaccines.

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation.

Brexit talks are on a knife edge as the transition period nears its end and the EU’s chief negotiator Michel Barnier has threated to pull out of negotiations in London this weekend unless the UK changes its stance on issues such as fishing and state aid.

Torbett said: “We are as prepared as we can possibly be, but we don’t need this extra red tape, extra complexity, extra cost and extra delay getting in the way of our supply chain at a time where we’re trying to deal with COVID.

“Clearly this is very frustrating and all of the time and effort and resource that has been put into the multiple levels of scenario planning around Brexit is time and effort and resource that could have been put to other better uses.”

The ABPI had better things to say about the spending review, however.

The industry welcomed £3 billion pledged to support the NHS from the impact of COVID-19 and noted a £14.6 billion funding boost to help the UK grow as a leader in science and technology.

Torbett said in a statement: “As the government focuses on its growth agenda, it should look to life sciences and make the most of this funding to unlock the future potential of our sector.

“Policies that encourage investment into cutting-edge research – such as delivering on the vision for UK health data – will deliver a triple win: for jobs, for the economy, and for the UK’s world-beating life sciences sector.”

Sunak also announced £6 billion in funding to pay for coronavirus vaccines, which is part of a package of measures designed to help the country recover from the pandemic worth £55 billion.

“As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right. Today’s funding will help them and the NHS plan for this enormous task and work together so that the right logistics are in place,” said Torbett.

The ABPI said it wants further plans including capital grants for medicines manufacturing, enhanced R&D tax credits, investment in preventive healthcare and modernisation of NICE appraisal methods to further stimulate the life sciences sector.

 

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What, Us Worry

By KIM BELLARD

2020 has been an awful year.  Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic.  Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering, and over a quarter million of us didn’t survive to Thanksgiving.  If you haven’t been depressed at some point, you haven’t been paying enough attention.

Within the last two weeks, though, there has finally been some cause for hope.  Whether you want to credit Operation Warp Speed or just science doing what it does, we are on the cusp of having vaccines to battle COVID-19.  First Pfizer/BioNTech, then Moderna, and most recently, AstraZenica, announced vaccines that appear to be highly effective. 

We’re having our Paul Revere moment, only this time with good news.  The vaccines are coming!  The vaccines are coming!

It strikes me, though, that our enthusiasm about these vaccines says a lot about why the U.S. has had such a hard time with the pandemic; indeed, it tells us a lot about why our healthcare system is in the state it is. We’re suckers for the quick fix, the medical intervention that will bring us health.

Unless you were alive when Woodrow Wilson was President, COVID-19 has been the worst public health crisis of our lifetime.  It took some time for us to fully realize how bad it was going to be, and, even then, most of us underestimated exactly how bad that would be.  We may still be underestimating how bad these next few months will be.

We knew, of course, that we didn’t have any vaccine for this new virus, and that, at best, it would take some time to develop one.  We didn’t initially know what to expect when someone became infected, didn’t know the right treatments, didn’t know which therapeutics might help.  We weren’t even really sure how COVID-19 spread.  There have been many hard-won lessons. 

What we did know, though, was that we needed to take precautions.  Physical distancing, limiting social gatherings, wearing masks, contact tracing; we knew these things would help.  They wouldn’t prevent COVID-19 from spreading, they certainly wouldn’t cure it once infected, but they would mitigate. 

We couldn’t even do those right.

Mask wearing became a political issue.  It is not a coincidence that some of the areas with the lowest percent of people wearing masks are among the hottest spots for spread of COVID-19, such as North Dakota, which has the highest COVID-10 death rate in the world right now. 

While overall mask wearing has improved from the spring, to the point as many as 90% of Americans claim they usually wear a mask in public, it varies widely, as illustrated below:

Similarly, business shutdowns and stay-at-home orders have faced great resistance, again more along political lines than to intensity of COVID-19 cases.  There are no doubt grave economic impacts to them, as we’ve seen, but whatever such measures we tried in the spring are now seen as a price we are no longer willing to pay. 

Of course, if we had quicker and more widespread testing, and better contact tracing, we might not need such extreme measures, but we’re not very good at them.  We don’t have enough tests,  they take too long for accurate results, and a sizeable number of Americans view contact tracing with suspicion. 

The CDC pleaded with us to celebrate Thanksgiving at home with only the people we live with.  Do we listen?  Of course not; nearly 40% of us plan to attend large gatherings.  Over a million Americans flocked to the airport yesterday – the highest daily number since mid-March – with millions more expected to travel between now and Thanksgiving.  That is admittedly down from previous years, but at a time we are regularly breaking daily records for cases, hospitalizations, and deaths, it seems rather foolhardy. 

Why should we worry?  There’s a vaccine coming. 

Of course, no vaccine has yet been approved, none is in full production, there are tremendous production and logistical issues to overcome.  It will take many months to have enough supply to vaccinate enough people to make an impact on COVID-19’s spread. 

Equally troubling, experts estimate that, even with a vaccine that is over 90% effective,  over 70% of people have to get vaccinated.  That may be a problem; fewer than 60% of Americans say that would be willing – and that’s up from earlier in the year.  Even healthcare workers, who are expected to be first in line when vaccines become available, are not yet convinced they’ll take it.

There may be a light at the end of this particular tunnel, but it’s a long tunnel. 

We’ve all got pandemic fatigue, we all want COVID-19 gone, we all want to go back to our “normal lives,” but we don’t seem quite able to bring ourselves to do the things we should in order to help bring those about.  Somehow, we assume, doctors and scientists will fix things for us.  It’s par for the course.

We don’t do enough about our diet and exercise; it’s easier to just take pills for our high blood pressure and bad cholesterol.  We don’t eat enough fruits and vegetables, so we take supplements to get the necessary vitamins and minerals.  We don’t stay active enough, so we end up with hip and knee replacements.  We claim to worry about the safety of vaccines, but give processed food manufacturers carte blanche to tailor their products to maximize our consumption. 

 We debate the need for universal coverage, but don’t spend nearly enough time talking about food or housing insecurity.  We not only can’t persuade ourselves to take climate change seriously, we don’t even care to ensure that our water and atmosphere are safe now.

It’s easier to trust health care to protect our health than to take responsibility ourselves, even though medical care is estimated to only account for 10-20% of our health.  So why wear a mask?  Why social distance?  Why stay in our family bubble?  Soon there will be a vaccine.  We need to stop acting like the proverbial damsel in distress waiting to be rescued, and start taking more responsibility for our own health – for COVID-19 and all the health issues we face. 

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot

AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident.

According to Reuters, the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222.

Results announced earlier this week showed that by giving a half dose, followed by a full dose a month later, the vaccine’s efficacy could be boosted from 62% to around 90%.

AZ originally planned for trial participants in the UK to receive two full doses but researchers found that certain side effects such as fatigue, headaches or arm aches were milder than predicted.

Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AZ, said: “The reason we had the half dose is serendipity.

Mene Pangalos

“So we went back and checked…and we found out that they had underpredicted the dose of the vaccine by half.”

Researchers decided to continue with the half dose group and administer the second booster shot as previously planned.

Results showed that in the group treated with the half dose, the vaccine was 90% effective, leading to an overall efficacy of 70% across the two dosing schedules.

“That, in essence, is how we stumbled upon doing half dose-full dose. Yes, it was a mistake.”

The error could make all the difference, cutting the amount of vaccine required for a strong therapeutic effect and allowing greater coverage.

Although at 90% effectiveness AZ’s shot would lag slightly behind RNA-based rivals from Pfizer/BioNTech and Moderna, AZD1222 is easier to handle and can be stored in fridges instead of at ultra-cool temperatures.

The revelation means that the stronger regimen could be added to a growing list of medicines discovered by accident – Alexander Fleming famously discovered penicillin after noticing a mould producing the compound was killing bacteria in a petri dish.

Pfizer’s erectile dysfunction drug Viagra was initially trialled as an angina drug before scientists at Pfizer’s laboratory in Sandwich, Kent, stumbled upon its other properties in a story so famous that Spike Lee is to direct a musical about the discovery.

It’s still not clear whether AZ’s vaccine discovery will be celebrated in popular culture as regulators have not yet approved it, but the incident shows the unpredictable nature of drug R&D and that after years of painstaking research good fortune is sometimes needed to get projects over the line.

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AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots:

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NBC News

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AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective.

AZ made the announcement as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

Another regimen of the vaccine codenamed AZD1222, given to 8,895 patients showed 62% efficacy when given as two full doses at least one month apart.

The combined analysis shows efficacy of 70% and the company said there were no serious safety events confirmed as related to the vaccine.

AZ said the trial has therefore met its main efficacy goal and will immediately prepare filings to regulators around the world to allow early approval.

It will also seek an Emergency Use Listing from the World Health Organization to make the shot quickly available in low income countries.

AZ made no further reference to the safety scare that caused trials of the vaccine to be halted for several weeks in September.

The AZ vaccine also has a considerable convenience advantage over RNA-based vaccines from Pfizer and Moderna.

The AZ shot can be stored at refrigerator temperatures making distribution much easier, while the vaccines from Pfizer and Moderna require ultra-cool temperatures to prevent their active ingredients from breaking down.

AZD-1222 is based on a weakened cold virus that causes the disease in chimpanzees, which has been modified so that it causes the body to code for the “spike” protein seen on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

The body produces antibodies against the protein, which neutralise the coronavirus in the event of an infection.

AZ announced the news as reports suggested the UK could approve Pfizer’s rival by the end of the week.

Citing a gated report from the Daily Telegraph, Reuters said the Medicines and Healthcare Products Regulatory Agency could have concluded its review of the shot developed by Pfizer and BioNTech by the end of the week.

This would allow distribution of the vaccine to begin during the first week in December.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end.

The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data.

On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

There was also solicited safety data from a random subset of around 8,000 patients aged 18 or above and unsolicited safety data from around 38,000 trial participants.

Pfizer said the companies are ready to distribute the vaccine candidate “within hours” after authorisation, which should occur within the next month or so.

The FDA this week authorised Eli Lilly’s baricitinib, just over a month after the company announced supportive phase 3 data in COVID-19.

While the regulator has not given guidance on how long the review will take, expect a similar, if not quicker, timeline given the importance of a working vaccine in the effort against the pandemic.

The companies have already begun rolling submissions across the globe including in Australia, Canada, Chile, Europe, Japan and the UK, and plan to submit applications immediately to other regulatory agencies around the world.

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer and BioNTech are also working with governments and health ministries around the world to set up delivery arrangements for the vaccine, which must be stored at around -70C to maintain its integrity.

According to reports Pfizer has already designed “pizza box” storage cases for the vaccine to help with this and will likely distribute them from several hubs in each country.

The companies said they had already built up expertise after delivering the vaccine to more than 150 clinical trial sites across the US, as well as Europe, Latin America, and South Africa.

The phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate or placebo as of 13 November, 2020.

It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Feature image courtesy of NIAID/Rocky Mountain Laboratories

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Pfizer prepares to file COVID-19 shot after reaching safety milestone

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports.

The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% effective, according to an interim analysis of a phase 3 trial.

Bourla was speaking at a virtual conference hosted by the New York Times, without saying when the company expected to file for the Emergency Use Authorization with the FDA.

“We are preparing now for submissions,” said Bourla.

However the company has already said it would have the two months of safety data required by the FDA by the third week of November.

But according to Bloomberg he conceded that there are important questions about the vaccine that remain to be answered, such as how long it remains effective.

“When it comes to how durable the protection could be, this is something we don’t know yet,” he said.

More efficacy results are due soon, he said.

Developed in partnership with Germany’s BioNTech, Pfizer’s vaccine is slightly ahead of a rival from Moderna in development.

Both vaccines are based on mRNA technology but Moderna’s rival seems to be slightly more effective with an efficacy of 94.5%.

Moderna’s shot is also easier to handle, requiring storage at -20C instead of the much more challenging -70C for the Pfizer vaccine.

There are also issues with access to an already available therapy for COVID-19, Eli Lilly’s antibody therapy bamlanivimab, according to reports.

Reuters reported that hospitals in the US are rationing use of the drug because demand is outstripping supply following an EUA from the FDA last week.

The federal government has paid $1,250 per dose for 300,000 doses of bamlanivimab, enough to last for a week at current infections levels, according to Reuters.

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Pfizer begins US pilot delivery programme for COVID-19 vaccine

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements.

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

But it has a major drawback in that it must be shipped and stored at around -70C, unlike conventional vaccines that are stored at standard refrigerator temperatures.

The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge.

Pfizer told Reuters in a statement: “We are hopeful that results from this vaccine delivery pilot will serve as the model for other US states and international governments, as they prepare to implement effective COVID-19 vaccine programmes.”

The four states will not receive the vaccine earlier because of the pilot, according to Pfizer.

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator.

It was the first company to announce top-line phase 3 results showing that its vaccine is effective last week.

Pfizer and BioNTech have a $1.95 billion deal to supply 100 million doses of the vaccine to the US government, which has an option to acquire up to 500 million additional doses.

There are 11 potential COVID vaccines in late-stage clinical development and since Pfizer’s announcement two more groups from Russia’s Gamaleya Research Institute and US biotech Moderna have published favourable efficacy results.

Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus.

They both code for the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus, which causes the body to produce antibodies that neutralise the virus in the event of an infection.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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COVID-19 vaccine: More good news as Moderna releases results

Looks like more good news on the COVID-19 vaccine front. Dr. Fauci’s prediction that the Pfizer/BioNTech foreshadowed positive news for future vaccines appears to have come true. Stat News reports:

The Moderna vaccine reduced the risk of Covid-19 infection by 94.5%. There were 95 cases of infection among patients who received placebo in the company’s 30,000-patient study. There were only five infections in patients who developed Covid-19 after receiving Moderna’s vaccine, mRNA-1273…
Moderna also released data about the number of patients who had severe Covid-19. There were 11 cases of severe disease, all of them in the placebo group — another point of encouragement for Fauci.
“There was always the concern … since the primary endpoint [of the trial] is just clinically apparent disease, how do we know it’s going to have an impact on severe disease? And the results with severe disease were striking — 11 to zero is very impressive,” he said. At the time of their data release, Pfizer and BioNTech had no severe cases in their study.

Very exciting news!

J&J begins trial of two-dose COVID-19 vaccine regimen

Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as a two-dose regimen.

The company’s Janssen pharmaceuticals and vaccines unit has already begun the ENSEMBLE study testing the single-dose vaccine and plans to enrol up to 60,000 participants worldwide.

It has now begun the two-dose regimen trial ENSEMBLE 2 trial, which will run in parallel with the first ENSEMBLE and will recruit up to 30,000 people worldwide.

The company acknowledged that a single-dose vaccine with a good safety profile would have significant benefit but is assessing other dosing regimens as well to see if they work better in the long term.

ENSEMBLE 2 study is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older.

Patients may or may not have stable comorbidities associated with an increased risk for severe COVID-19.

The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.

Janssen is testing the vaccine in countries with high infection rates, such as Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.

In the UK, ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR).

There are 11 vaccines in late stage-development, according to the World Health Organization, including the Pfizer/BioNTech shot, which is more than 90% effective according to top-line clinical trial results announced last week.

BioNTech’s co-founder professor Ugur Sahin told the BBC’s Andrew Marr show that if it is approved by regulators, the vaccine’s impact will significantly kick in over summer, leading to resumption of normal life by next winter.

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Hungary steps out of line with EU to order Russia’s COVID-19 vaccine

Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate.

According to press reports, the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either.

The European Medicines Agency has announced rolling reviews of vaccines from mainstream pharma companies including Pfizer/BioNTech and AstraZeneca, which allow regulators to review data in real time, allowing them to reach a conclusion quickly.

Minister of foreign affairs and trade Peter Szijjarto has been in talks with Russia, China and Israel in order to obtain early supplies of a vaccine.

Hungary’s prime minister Viktor Orban has warned that the country’s health service could be overwhelmed if the infection rate is not brought under control.

The decision from Orban is the latest example of the country stepping out of line with the rest of the EU, which is abiding by guidance issued by the EMA.

Earlier this week Russia claimed that Sputnik V was 92% effective, based on interim data from a study in involving 40,000 subjects.

The results would put it on a par with a vaccine developed by Pfizer/BioNTech, which has shown efficacy of more than 90% and no serious safety issues in more than 43,500 subjects.

The preliminary assessment is based on 20 COVID-19 cases split between the vaccinated and placebo arms of the study at 21 days, according to a press statement issued by the Gamaleya Institute which developed the vaccine and the Russian Direct Investment Fund (RDIF).

They said the positive interim results will be followed by “mass vaccination in Russia against COVID-19 in the coming weeks.” The country has had more than 1.8 million confirmed COVID-19 infections, and just over 31,000 deaths.

The readout from the study comes at a point when 20,000 people have been given the first of the two-dose regimen for the adenovirus-based vaccine, and 16,000 have had the second. There were no unexpected adverse events as yet, with most side effects injection site reactions or minor flu-like symptoms.

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GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots:

  • Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant
  • The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of age and in elderly subjects aged ≥65yrs.
  • P-II trials will be conducted in multiple locations across Canada and, upon FDA’s approval, in the US. The P-III studies will start before the end of 2020 and will evaluate CoVLP in ~30,000 volunteers globally

Click here­ to­ read full press release/ article | Ref: GSK | Image: BioPharma Reporter

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EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients.

The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end of this year. There is an option for a further 100 million doses.

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021.

Regulators sitting on the European Medicines Agency’s CHMP scientific committee have already begun a rolling review of the vaccine, which will accelerate the process as they will be able to study trial results as they are made available.

Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then doses will be ordered by the EU Member States who have elected to receive the vaccine as part of this agreement.

The Pfizer/BioNTech vaccine is based on mRNA, which instructs the body to produce the “Spike” protein on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

It does have one practical drawback as it must be stored at around -70C until the day it is used and there are already concerns this may make large scale vaccination schemes difficult.

The Independent reported that AstraZeneca’s rival vaccine, which is based on a viral vector and is also nearing the end of clinical development, could be easier to work with.

The AZ vaccine can be stored at fridge temperature, although there have been concerns about its safety after a late stage clinical trial was put on hold at the beginning of last month before resuming.

While Pfizer was keen to take the plaudits for developing a vaccine at speed from a standing start at the beginning of the year, it also faced uncomfortable questions about the conduct of its CEO Alfred Bourla.

It emerged that Bourla sold shares worth almost $5.6 million on Monday as part of a pre-planned sale on the day of the vaccine news release – which sent the company’s stock price soaring.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Shots:

  • J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the US, South Africa, and some Latin American countries are already ongoing
  • Clinical trials to be resumed are the P-IIa studies in Germany, the Netherlands, and Spain and P-I/IIa study in Belgium
  • The company is preparing for the initiation of a second P-III study of the COVID-19 vaccine candidate. The trial will evaluate a 2-dose regimen and is anticipated to start later this month across the EU. The study follows positive interim results of the P-I/IIa study, showing the safety profile and immunogenicity of the COVID-19 vaccine was supportive of further development

Click here ­to­ read full press release/ article | Ref: Janssen | Image: Law.com

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NHS set to roll out COVID-19 shot in New Year, says health secretary

The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock.

In an interview with the BBC Hancock said that the vaccine could be available by Christmas, but he expected a mass roll out “in the first part of the new year”.

Vaccination clinics would be open seven days a week and he said he is giving an extra £150 million to run them.

But he urged patience, saying it is unclear how many people will have to be vaccinated before life can return to normal.

Hancock made the comments after the landmark announcement from Pfizer and its partner BioNTech that their COVID-19 vaccine protected about 90% of patients from the disease in a phase 3 trial.

The UK government has ordered 40 million doses of Pfizer’s vaccine and European and UK regulators have begun rolling reviews of the most advanced vaccine candidates.

This allows the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to review data in real time, reducing the time taken from more than a year to a matter of weeks.

As reported by pharmaphorum, the UK could get the vaccines before the EU if the MHRA is faster with its review.

The BBC said the review could be complete by the end of this month.

GPs have been told to prepare to give patients two vaccine doses, to be delivered between 21 and 28 days apart.

Clinics could run between 8am and 8pm, according to the British Medical Association.

Only small numbers of the vaccine will be given in December with most shots taking place in 2021.

The government also hopes that mass testing will also help to turn the tide, by giving people accurate information about whether they have the virus or not, allowing them to go about their business if they are clear.

Shortly after Pfizer announced its trial success, it emerged that another late-stage contender from China’s Sinovac hit a safety issue.

A clinical trial in Brazil was put on hold after health authorities reported a “severe adverse” incident.

The Brazilian health regulator Anvisa said the incident took place on 29 October.

There are 47 COVID-19 vaccines in clinical development and 10 in phase 3, according to a regularly updated document from the World Health Organization.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Divided Congress paves way for drug price reforms on Biden’s watch

Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but faces the challenges of a divided Congress when it comes to implementing important health policies.

Making healthcare affordable is one of Biden’s goals as many Americans struggle to pay for healthcare, including those who have lost their jobs in the pandemic and with it their health insurance schemes.

High drug prices was a touchstone issue in the 2016 elections and Biden has also made this a priority in his campaigning.

Brian Bewley, partner in the life sciences and healthcare practice at corporate law firm Goodwin, said: “President-elect Biden has consistently prioritised affordable healthcare for all.  This includes reducing drug costs to consumers in the United States.

“In order to accomplish this, Biden has proposed allowing US Government agencies to negotiate directly with pharmaceutical manufacturers on drug pricing, enacting legislation to effectively limit or cap drug prices (brands and generics), and allowing consumers to purchase drugs from foreign countries.

“If any of these are successful, it could materially impact profit margins for the drug manufacturers.”

The Senate elections have not been decided and at the time of writing the House of Representatives is set to remain under control of the Democrats by the slimmest of margins.

This means that Biden will have to use all his charm and persuasion to bring legislators in line in a Congress that is reflective of the rifts in US society, although he may have support for drug price reform, according to Goodwin.

He said: “Right now, the Senate majority hangs in the balance with Democrats and Republicans holding at 48 seats each, with four seats outstanding.  That said, it appears that if Republicans have a majority, it will be by a slim margin.

“When it comes to President-elect Biden’s agenda on reducing drugs costs, he may have bi-partisan support – especially when you consider that the current administration under President Trump also tried to address drug pricing and transparency.”

According to Goodwin many states have been more aggressive than the Federal government on drug pricing and at least 15 have passed prescription drug price transparency laws, requiring manufacturers to report price increases exceeding a certain threshold.

These laws are meant to help states identify generics for their own prescription drug development programmes.

“I don’t see states being a major obstacle or impediment to President-elect Biden’s agenda on drug pricing as the states have, in many ways, outpaced their federal government counterpart,” said Goodwin.

Obamacare and COVID-19

Biden is an architect of the Affordable Care Act  and helped to implement the legislation as vice president of the Obama administration.

He will attempt to expand this legislation, nicknamed “Obamacare”, after Trump’s Republicans unsuccessfully tried to unpick it with their withdrawn American Health Care Act.

A likely addition to the legislation is a new “public option” to cover uninsured Americans and expansions of Medicare and Medicaid cover to older people and those on lower incomes respectively.

In the shorter term the COVID-19 pandemic will be a major focus as the country gears up to put together a mass vaccination programme.

Biden is an advocate of mask wearing, saying that doing so could save almost 70,000 lives.

But whether governors of Republican-leaning states will stand by his proposal to make mask-wearing mandatory outside their household is another matter.

The Trump administration became increasingly resistant to measures such as mask-wearing and social distancing played a part in the election, with Trump advising his supporters to attend polling stations in person and Biden urging his voters to use postal ballots instead.

Biden has set out proposals to improve testing and tracing, with the federal government taking responsibility for personal protective equipment (PPE) for healthcare workers.

Other measures include allowing the Centers for Disease Control to take the lead on how to control the disease with social distancing measures.

His seven-point pandemic plan also outlines proposals to protect higher-risk groups such as older people and these from certain ethnic minority groups.

He also plans to rebuild links with the World Health Organization, which Trump famously defunded after blaming it for failing to effectively control the COVID-19 pandemic.

As the world digested the news that Pfizer/BioNTech’s vaccine could be more than 90% effective Biden said he will make distributing a vaccine a priority.

With the rising cases every day, it’s the part of Biden’s plan that’s less likely to face political pushback, although there is distrust among the public about vaccines.

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Positive news on a COVID-19 vaccine

Great news on progress for a COVID-19 vaccine from Pfizer. From their press release:

  • Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

The Phase 3 clinical trial of BNT162b2 began on July 27. Pfizer expects to produce o produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Note that since this is a two-dose regimen, this would be sufficient capacity for 25 million people this year and 650 million people next year.

Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis.

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements.

Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose, the companies noted.

This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

The companies cautioned that as the study continues, the final vaccine efficacy percentage may vary.

The independent data monitoring committee that conducted the interim analysis said that there had been no serious safety concerns identified.

It recommended that the study continues to collect additional safety and efficacy data as planned.

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier.

The phase 3 clinical trial of BNT162b2 began at the end of July and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.

Around 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.

The vaccine is based on a strand of messenger RNA – a short segment of genetical material that codes for the “Spike” protein found on the surface of the coronavirus.

These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

Last month the companies aid that they are already producing hundreds of thousands of shots each day should the vaccine get approved.

However it remains to be seen whether countries such as the US and UK, which have ordered millions of shots, will be able to organise a mass vaccination programme after failing to implement track and trace measures that could also slow the spread of the disease.

Pfizer’s CEO Albert Bourla said: “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The vaccine is one of 47 in clinical development, according to the World Health Organization, showing several shots developed in China and a rival from the UK’s AstraZeneca are also close to reading out late-stage clinical results.

The pharma industry has developed vaccines for COVID-19 in record-breaking time after scientists from China published details of the SARS-CoV-2 virus shortly after the outbreak began in January.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Drugs and vaccines may not swiftly end pandemic, says Merck & Co’s CEO

Merck & Co’s CEO Kenneth Frazier has warned that the drugs and vaccines in the pipeline to combat COVID-19 may not be enough to swiftly end the pandemic.

Speaking to CNBC, Frazier said that the drugs and vaccines to treat COVID-19 are not a “silver bullet” solution to the pandemic, meaning people are likely to be wearing masks and practicing social distancing measures well into 2021

He told CNBC’s Squawk Box: “I don’t see the therapeutics that we have – or the vaccines that are coming – as a silver bullet.

“I would say certainly well into 2021 we’ll still be trying to observe these public health measures.”

Frazier said he is “very optimistic that in the near future” there will be positive results coming from late-stage clinical trials for COVID-19 vaccines and therapeutics.

A potential vaccine is unlikely to be widely available for people until mid-2021, Frazier noted.

It’s expected that vaccines will only work in around 70% of cases and Dr Anthony Fauci, White House coronavirus adviser, said that the likelihood of a highly effective COVID-19 vaccine providing coverage in around 98% of people is slim.

Frazier added: “The natural history of viruses is that they don’t go away.

“I don’t think we should tell people that they can expect to give up on those public health measures anytime soon.”

US-based Merck & Co is developing two separate potential COVID-19 vaccines, one from the Australian vaccine manufacture Themis that it acquired in July and with scientific non-profit organisation IAVI.

However the company known as MSD outside North America is well behind the leaders in the COVID-19 vaccine race, which according to the World Health Organization are phase 3 candidates from China’s Sinovac and Sinopharm, followed by the UK’s AstraZeneca.

Frazier made his comments as the US sees a deadly surge of the coronavirus just as voters go to the polls to decide whether incumbent Republican president Donald Trump stays on for another four years, or is replaced by his Democrat rival Joe Biden.

Trump’s handling of the pandemic has been a focus point in the campaigns for the White House, with nearly 9.4 million confirmed cases and 231,000 deaths attributed to the disease.

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BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year

A
renewed interest in whether the BCG vaccine (for tuberculosis) could also have
an application for COVID-19 has been on the rise, as
evidenced by this recent Cell publication, the University of Exeter’s involvement in the BRACE Trial and ongoing general press coverage.
Furthermore, the list of clinical trials focusing on
this area is continuing to grow (and is available here).

The correlation between BCG and COVID-19 was also the subject of the BCG Hackathon spearheaded by the University of Ottawa, Estafet and Elsevier, which we previously discussed in this blog. Given the intense interest in the subject, we’re happy to announce that the deadline for Task 2 of the Hackathon has now been extended to December 31, 2020.

This task draws on the recently updated BCG Atlas data from the
first task of the Hackathon, and it is focused on using machine learning and
data science to find insights that could help the ongoing clinical trials.

Can you help find insights that could help the ongoing clinical
trials in this area?

If so, we would love for you to get involved and bring your
expertise to some of the questions we’ve been exploring. Among the
questions we are looking to answer are:

  • Is BCG vaccination causally related to reduced COVID‐19 mortality, or are other factors – like lockdown and average age of the population – responsible for the different mortality rates?
  • If BCG vaccination reduces COVID-19 mortality, what are the key factors, for example: How long does the immunity engendered by BCG last after vaccination? Which BCG strain has been used? What is the optimal time to vaccinate?

And, of course, we are also interested in
hearing alternative hypotheses as well.

If you are interested in helping with Task 2 of the Hackathon, please click here to get involved. We hope you’ll join us in this important effort!

Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13

Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114.

The two trials are both in adult subjects, a group that has been driving growth of Prevnar 13 in the last few years, and showed that V114 stimulated immune responses to all 15 pneumococcal serotypes included in the vaccine.

In the PNEU-PATH and PNEU-DAY studies, dosing with V114 was followed a year later by a shot of Merck’s older polysaccharide-based Pneumovax 23 vaccine, and showed that the combination was protective in the over-50 and under-50 adult age groups, respectively.

US-based Merck already has phase 3 data in hand backing the safety and efficacy of V114 in children as well as non-inferiority to Prevnar 13 for the serotypes the two vaccines share. It reiterated its plans to file for approval of the vaccine before the end of the year in the US.

Prevnar 13 – which as its name suggests covers 13 serotypes – is the world’s top-selling vaccine, adding almost $6 billion to Pfizer’s top-line last year thanks to its dominant position in the paediatric pneumococcal shot market.

Added to that, it’s not due to lose patent protection until 2026, when analysts predict it could make more than $7 billion, although it’s worth noting that growth has been pegged back so far in 2020 as a result of the pandemic lockdowns.

Merck is hoping to trump its rival with 15-valent V114, as it provides protection against two serotypes – 22F and 33F – that aren’t included in Pfizer’s product. It also provides an opportunity to expand its position in the adult pneumococcal disease market, where Pneumovax 23 is still widely used.

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Merck’s chief medical officer Roy Baynes.

“These data provide important information about the potential for V114 followed by Pneumovax 23 [which is] included in more than 90% of age-based adult pneumococcal immunization programmes globally,” he added.

Pfizer isn’t resting on its laurels however, and is preparing to defend its Prevnar franchise, reporting positive clinical results with a 20-serotype follow-up – called PF-06482077 or 20vPnC – that it also thinks could be ready for filing before the end of the year.

As a backup it has also been developing a 7-serotype shot that would provide the same breadth of cover as 20vPnC when combined with Prevnar 13.

Pneumococcal disease is caused by Streptococcus pneumoniae, and includes non-invasive illnesses like pneumonia, sinusitis and middle ear infections, as well as invasive diseases like meningitis.

It can be particularly problematic in young children under two and adults aged over 65, as well as people with compromised immune systems.

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AZ’s COVID-19 vaccine trial ready to resume – reports

AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports.

Citing four sources, Reuters said that the FDA is about to allow the large-scale trial of the shot to resume after it was put on hold on 6 September when a participant in the UK fell ill.

AZ has not confirmed the nature of the illness because of concerns over patient privacy, but according to press reports the person developed the rare spinal inflammatory disorder transverse myelitis.

Reuters said its sources were briefed on the matter but asked to remain anonymous but said the trial could resume later this week.

It is unclear how the FDA characterised the disease that caused the stoppage and the regulator has so far declined to publicly comment on the matter.

The FDA is requiring trial researchers to add information about the incident to consent forms signed by study participants, one of the sources told Reuters.

UK regulators allowed the trial to resume a week after it was put on hold – according to Reuters’ sources this was because there was “insufficient evidence to say for certain” that it was not related to the vaccine.

The Medicines and Healthcare products Regulatory Agency (MHRA) recommended that vaccinations should continue but with close monitoring of the affected person and other participants.

The FDA has publicly stated the importance of safety data for COVID-19 vaccines – they will be given to healthy individuals and there is very little tolerance for any side effects.

The regulator has said manufacturers must have at least two months’ worth of safety data before filing a COVID-19 vaccine, amid concerns that the Trump administration may attempt to rush approval ahead of the US election on 3rd November.

As Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, pointed out to Reuters, regulators have to weigh whether a rare side effect is vaccine-related and could occur again.

Transverse myelitis occurs at a rate of one in 200,000 people and he noted it would be unusual to see it in a trial of 9,000 people.

But other viruses including West Nile and polio can trigger the condition, as well as physical trauma.

Regulators in Brazil, India and South Africa have also allowed trials to resume.

Until the safety issue AstraZeneca had been a frontrunner in the race to produce a vaccine for COVID-19.

Johnson & Johnson has voluntarily put a trial of its potential rival vaccine on hold because of a safety issue.

According to the World Health Organization, there are 44 candidate vaccines in clinical trials, with three shots developed in China listed as most advanced followed by the AZ vaccine.

pharmaphorum has approached AZ for comment.

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UK government signs contract for COVID-19 challenge trial

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective.

Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the trial model.

This will involve manufacture of the challenge virus and the first-in-human characterisation study for the virus.

The characterisation study, which is expected to be completed in May 2021, still needs ethical and regulatory approval.

It is designed to assess the minimum dose of the virus required, before moving on to the next stage when a vaccine will be administered.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics.

hVIVO will also be expanding its clinical operations in London to conduct the trial.

It’s not clear which vaccine will be involved in the study – there are several in the last stages of clinical development and the UK government has orders for candidates from AstraZeneca, Pfizer/BioNTech, Novavax, Valneva, Sanofi/GSK and Johnson & Johnson.

No financial details of the contract with hVIVO were disclosed.

Challenge trials are controversial because of the risks involved with infecting patients with a potentially lethal virus, although with the SARS-CoV-2 coronavirus these could be managed as most people develop mild symptoms and those at high risk of a serious infection are relatively easy to identify.

hVIVO is already known for its challenge studies in other infectious diseases, which are conducted a 24-bedroom quarantine clinic with onsite virology, providing individually isolated rooms and connected to a specialist laboratory facility.

Open Orphan, which comprises of two commercial CRO services business hVIVO and Venn Life Sciences, has been working on several coronavirus challenge study models and expects to be busy over the next few months helping several pharma and biotech companies test their vaccines.

Anyone interested in being contacted and provided with details about future COVID-19 human challenge study research may leave their contact details at www.UKCovidChallenge.com.

The World Health Organization has been keeping tabs on the development of vaccines since the start of the pandemic and says there are now 44 in clinical development.

The three most advanced are being developed in China where the pandemic is thought to have originated, followed by a candidate from Oxford University and AstraZeneca in the UK.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available.

The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA.

In a letter published on its website Pfizer may have the data to say whether the vaccine is effective this month, based on the findings of the ongoing 40,000 person clinical trial.

But CEO Alfred Bourla cautioned that the safety data will only be ready in the third week of November.

There have already been two safety scares in COVID-19 vaccine trials – Johnson & Johnson earlier this week put its phase 3 trial on hold because of an undisclosed illness in a patient.

A US trial of AstraZeneca’s shot is also on hold after a similar incident, although studies in other parts of the world have restarted.

As vaccines will be given to healthy individuals, regulators have far less tolerance for adverse events.

There are further concerns that political interference during the election build-up could undermine the credibility of a mass vaccination programme.

Bourla said: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US. soon after the safety milestone is achieved in the third week of November.”

Despite the concerns of scientists president Donald Trump has said that there would be a vaccine available before the election on 3rd November and is hoping that approval could be the “October Surprise” that could boost his popularity ahead of the vote.

Rival Moderna has said it could apply for an Emergency Use Authorization for its rival vaccine as soon as November.

The European Medicines Agency has already started a rolling review of the Pfizer/BioNTech and AstraZeneca vaccines.

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GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses

Shots:

  • GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act
  • The collaboration will focus on development of specific antibody candidates identified by Vir’s platforms (VIR-7831 and VIR-7832) which demonstrated high affinity for SARS-CoV-2 spike protein and highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. The companies plan to proceed directly into P-II clinical trial within next 3 to 5 mos.
  • Vir’s antibody platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, SARS-CoV-2, malaria, and others

Click here to­ read full press release/ article | Ref: GSK | Image: BGR

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BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

The post BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2 first appeared on PharmaShots.

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University.

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival.

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

It’s hoped that this will hasten the process, which would take more than a year in normal conditions.

Once the CHMP thinks there is enough data the company submits the complete filing, allowing the committee to reach a fast decision, which is passed on to the European Commission.

The CHMP begun its review of the vaccine, known as BNT162b2 based on preliminary results from pre-clinical and early clinical studies.

These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

The RNA instructs the body to produce copies of the Spike protein found on the surface of the coronavirus, which produces an immune response and causes the body to neutralise the virus if it infects the body.

BNT162b2 is being tested in a global phase 3 study ongoing at more than 120 clinical sites worldwide including the US, Brazil, South Africa and Argentina.

To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

It lists a candidate developed by China’s Sinovac as the most advanced, with AZ’s shot now fourth on the list after trials were temporarily halted because of a potential safety issue.

Pfizer’s is further back on the list, although there are suggestions that it could be approved in the US in time for the presidential elections on 3rd November.

US trials of AZ’s vaccine have not restarted while the FDA investigates the safety issue that caused the trials to be paused around a month ago.

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Older people first to receive COVID-19 vaccine in UK, says government

As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease.

According to weekend press reports a rollout of a vaccine could be just three months away – but the feedback from the government is that not everyone will get it, with the target group being around 30 million older people and health workers, less than half the population of 67 million.

Speaking to the Financial Times, the head of the country’s coronavirus vaccine task force Kate Bingham said that any vaccination programme will be targeted at the most vulnerable in society.

She said: “People keep talking about ‘time to vaccinate the whole population’ but that is misguided.

“There is going to be no vaccination of people under 18. It’s an adult-only vaccine for people over 50 focusing on health workers and care home workers and the vulnerable.”

The strategy will likely be based on a draft list published last month by the government’s Joint Committee on Vaccine and Immunisation (JCVI), showing who is likely to be first to receive the vaccine.

According to the JCVI a “simple age-based programme” will decide who gets priority, as this will allow the vaccine to get to those at highest risk at the fastest possible speed.

Older adults in care homes and care home workers would be in the first group, followed by those aged over 80, over 75, over 70 and over 65.

A sixth priority group would comprise of younger adults under 65 with conditions that leave them at high risk of developing serious complications from the virus.

They would be followed by those aged under 65 who have a moderate risk level.

Even distributing the vaccine to half the population will be a major logistical challenge, however, and the UK government is facing scrutiny and criticism over its handling of the pandemic so far.

Flaws in the coronavirus reporting system emerged over the weekend when it emerged that nearly 16,000 cases had been missed in daily figures over the last week or so because of an IT error.

The government has also been criticised for failing to implement a track and trace system early in the pandemic, a measure that limited its spread in other countries.

Health secretary Matt Hancock has already said that the military may be brought in to help distribute the vaccine.

Getting what could be the final stage of the fight against COVID-19 right will be vital if the government wishes to restore credibility, as millions continue to live under lockdown restrictions that have cost thousands of jobs and continue to damage the economy.

The post Older people first to receive COVID-19 vaccine in UK, says government appeared first on .

European regulators begin rolling review of AZ’s COVID-19 vaccine

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take.

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”.

The rolling review, which is designed to speed up the assessment of a promising vaccine or drug by the EMA’s CHMP scientific committee, will continue until there is enough evidence available to support a marketing authorisation.

But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

All that the agency has is preliminary data from pre-clinical and early clinical studies suggesting the vaccine triggers the production of antibodies and T-cells that target the virus.

In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.

Trials have already restarted in the UK, Brazil, South Africa and India after one patient in the UK developed a potential side-effect that was deemed serious enough to cause the trial to be paused.

Discussions are still ongoing with the FDA, which has asked for further information before making a decision about resuming a trial in the US.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus that that causes common cold infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you!

We’ve seen the scientific community come together time and again throughout the COVID-19 pandemic, and we’re thrilled to have been part of a hackathon bringing together data scientists, epidemiologists and partner organizations focusing on analysing the hypothesis of whether the tuberculosis (TB) vaccine – BCG – could reduce COVID-19 mortality.

After the news hype mounted about COVID-19 and the BCG, Estafet and Elsevier came together to see if they could work with data scientists and the scientific community to help them to unearth true causation – rather than the correlation identified by researchers. Prof. Madhukar Pai (Dept of Epidemiology, Biostatistics & Occupational Health, McGill University) warned clearly about the risk of fanning the hype and the danger of causing a run on the BCG vaccine when it is still very much needed. When Elsevier’s Anita de Waard (VP Research Collaborations) spoke to Prof. Pai, he connected her with Dr. Alice Zwerling (University of Ottawa), who is currently responsible for maintaining the BCG World Atlas – a project initiated by Prof Pai. It became clear that to find new insights for BCG-COVID 19 trials, a better use of the power of data science would be to augment the data on the BCG World Atlas, so the hackathon was split into two.

And the winners are …

Task 1 – augmenting the BCG Atlas with the help of NLP (Natural Language Processing) and Text Mining – wrapped up this month, culminating in over 100 notebooks being submitted and generating a substantial amount of data for incorporation into the Atlas.

Second prize went to Marouane Benmeida. Marouane generated an additional 33 entities for BCG Atlas and was awarded $2000.

First prize went to Dimitrina Zlatkova. Dimitrina generated an additional 57 entities for the BCG Atlas, and was awarded $3000.

It’s
an extraordinary outcome for extraordinary times, and we’d very much like to
thank not only Dimitrina and Marouane for their great contributions, but all
the volunteers who came together to make this happen! The data created by the
hackathon will help current correlations with COVID-19, but is also in itself
of critical importance to researchers who work on tuberculosis vaccines.

The hackathon continues

And we’re not finished yet! In Task 2, Data Scientists will use this augmented data to find new insights for the BCG-COVID-19 clinical trials. Participants will be seeking to answer questions like:

Is the BCG vaccination causally related to reduced COVID‐19 mortality or other factors like lockdown and average age of the population are responsible for the different mortality rates?

If BCG vaccination reduces COVID-19
mortality, what are the key factors?
For example:

  • How long does the immunity engendered by BCG last after vaccination?
  • Which BCG strain has been used?
  • What is the optimal time to vaccinate?

If you’ve been inspired by this outcome and want to come on board for the second task, we’d welcome any and all input. For more detailed information on that task, and for those interested in continuing to contribute new data to the BCG Atlas, please visit the hackathon site and get involved!

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial.

There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.

The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8 times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection.

In older adults aged 65-85 treated with the vaccine candidate codenamed BNT162b2 there were 1.6 times more neutralising antibodies than in recovering patients.

Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants, the companies said.

The data builds on results announced last month, which also showed the antibody response and suggested that the vaccine produces a T-cell response against the virus.

Those results helped the companies choose BNT162b2 from a group of similar candidates for an ongoing phase 2/3 global study in up to 30,000 participants.

This began in July and has so far enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission.

Assuming the trial is a success, Pfizer and Germany’s BioNTech said they are on track to ask for a regulatory review as early as October, paving the way to supply up to 100 million doses by year end if the vaccine is authorised.

Pfizer and BioNTech are running a parallel trial in Germany and plan to announce further results from that in the “near future”.

There could be up to 1.3 billion doses manufactured by the end of next year, the companies said.

The vaccine is one of 30 potential vaccines identified by the World Health Organization as being in clinical development, with AstraZeneca and Oxford University top of the list.

The post Pfizer/BioNTech say COVID-19 jab on track for approval by year-end appeared first on .

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots:

  • The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants
  • In P-I study, BNT162b2 (@7days after the second dose of 30μg) elicited SARS-CoV-2–neutralizing GMTs in younger adults (18-55yrs.) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age), it elicited a neutralizing GMT 1.6 times the GMT of the same panel
  • The companies anticipate commencing the global (Ex- China) P-II/III study of BNT162b2 in up to 30,000 participants that started in Jul’2020, which has to date enrolled 11,000+ patients including in areas with significant SARS-CoV-2 transmission

Click here to­ read full press release/ article | Ref: Pfizer | Image: Smartworld

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Shots:

  • mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil
  • The company will produce API in its facility located in Garín (Argentina) and will send it to Mexico to complete the production and filling process. AstraZeneca will transfer its technology to the Garín plant shortly, allowing the facility to produce the vaccine in the coming months
  • AstraZeneca’s AZD1222 has demonstrated robust immune response in its P-I & II studies, being evaluated in P-III study with its expected completion in the coming months. The vaccine is expected to be available in the H1’21, upon completion of the P-III trial and approval

Click here ­to­ read full press release/ article | Ref: mAbxience | Image: Thailand Medical News

Related News: AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Shots:

  • The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose
  • If approved, the EC expects to facilitate a process for the allocation of the vaccine doses among the member states.
  • The exploratory talks concluded today are intended to result in an Advance Purchase Agreement to be financed with the Emergency Support Instrument, which has funds for vaccines with different profiles and produced by different companies

Click here to­ read full press release/ article | Ref: European Commission | Image: USA Today

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots:

  • AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region
  • The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries except Brazil
  • The clinical trial conducted in the US, South Africa, England, and Brazil is expected to be completed in Nov or Dec’2020, after which the company would seek approvals. If approved, AstraZeneca will transfer technology to Argentina’s INSUD Group and Mexico’s Laboratorios Liomont at the end of the year and begin manufacturing in Q1’21

Click here ­to­ read full press release/ article | Ref: Reuters | Image: Bloomberg

Related News: AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V

Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’.

According to press reports the vaccine has been tested on one of President Vladimir Putin’s daughters.

But World Health Organization leaders have said that they want to review the vaccine, called Sputnik V after Russia’s pioneering space probe, as the vaccine took just two and a half months to develop.

Sputnik V is not among the WHO’s list of six vaccines that are in phase 3 development and despite the accelerated trial timelines it is unlikely that one will become widely available until next year.

Russia plans to begin mass vaccinations against the coronavirus in October with the vaccine, which is based on adapted strains of the adenovirus that usually causes the common cold.

According to several press reports the vaccine has been approved before completion of a phase 3 trial, which would give a strong indication of the efficacy and safety in a large cohort of patients.

Putin has vouched for the safety of the vaccine, saying that it led to a one-degree temperature rise in his daughter to 38°C, which subsided after a day.

In cancer, drugs can be approved conditionally on the basis of earlier data, but regulators for COVID-19 outside Russia are requiring data from larger trials for approval.

They are looking for clear evidence that the vaccinations would provide immunity from the coronavirus.

Russia’s vaccine is also veiled in secrecy: the Gamaleya Institute in Moscow has not yet released safety or immunity data from studies for independent scientists to review.

According to the WHO, there are now 28 coronavirus vaccines in clinical development, with one from Oxford University and AstraZeneca top of the list.

This is followed by several vaccines from China, and another from US biotech Moderna.

The post Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V appeared first on .

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots:

  • The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA
  • The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global access of the vaccines
  • J&J expects to meet its goal to supply 1B doses globally through the course of 2021, provided the vaccine is safe and effective. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots

Related News: Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium




Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept the “new normal” until we have a vaccine.

What is a Vaccine?

Vaccines, in a way, activate the immune system without the disease. Getting a particular vaccine is somewhat like having survived the disease once, without the health burden. Vaccines can be made with weakened viruses, inactivated viruses, and protein from a virus or even just the biological material (mRNA).

How Do Vaccines Provide Immunity?

Immunity is the body’s defense mechanism is to resist the effects of a microorganism. Immunity induced by a vaccine is weaker than that induced naturally after an infection. After you get a vaccine shot, your body will develop long-lasting antibodies that circulate in the blood. Such virus-specific antibodies will help to prevent severe disease. The vaccine will not prevent the entry of the virus into the body (infection), but it will prevent severe infection.

Vaccine Development

Scientists have gone from the discovery of the virus to more than 165 candidate vaccines in record time, with 27 vaccines already in clinical trials.

Challenges in Vaccine Development

  • Laboratory development & Preclinical testing
  • Large Clinical Trials
  • New technology for production
  • Availability: manufacturing millions of doses especially of a novel coronavirus
  • Developing an integrated and fair plan for vaccine distribution
  • Order of priority – health workers, elderly, and those with underlying conditions
  • Logistic –storage temperature
  • Resistance from the public – lack of awareness
  • Supply to rural areas
  • Multiple-dose may be needed

When Can We Expect A Vaccine And How Has Development Been Stepped Up?

Vaccine development normally takes years to complete, but the continuing crisis has prompted the multilateral system to accelerate the process. Regulatory approvals are up to speed but no important stages are skipped. This means that different tests of the vaccine are conducted in “parallel”.

The pandemic situation requires multiple activities and tests to be conducted at financial risk to stakeholders without knowing whether the vaccine candidate will be safe and effective.

Clinical Status of Vaccines Around the Globe

Research in India

The Indian government agency is working at lightning speed to test and approve an Indian origin COVID-19 vaccine. The government has permitted six Indian companies to develop vaccines against COVID-19. Recently, Bharat Biotech and Zydus Cadila were granted permission to start Phase I and II human clinical trials of their most advanced vaccines, named COVAXIN and ZyCoV-D respectively.

India Will Be The Manufacturer of The Covid-19 Vaccine

India is known for its mass manufacturing of pharmaceuticals. Leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation to obtain their vaccines from India. Now is the time when India can definitely leverage its ability to mass-produce a Covid-19 vaccine whenever it is ready and also help reduce the price of these vaccines. Reasonable price provided by India`s mass production ability would be the only factor in assuring the Covid-19 vaccine’s access across the globe.

Serum Institute of India (SII) located in Pune has entered a manufacturing partnership with British pharmaceutical giant AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine. These vaccines will be for India and middle- and low-income countries across the world (GAVI countries).

What Happens If You Choose Not To Get A Vaccine?

Firstly, you will not be protected from the deadly respiratory disease and may end up suffering from a severe infection. Secondly, refusal by many people might not get the country to herd immunity.

What Lies In The Future?

Even when a vaccine is introduced, we will have several months of significant infection or at least a risk of infection to take care of. This means that we may have to face more months under the threat of the novel coronavirus than we have already survived. If precautions are not taken and guidelines are not followed, there will continue to be more outbreaks, more deaths. The availability of the vaccine will be the slow start of the flattening of the curve. The total time taken to completely flatten the curve cannot be predicted, as it depends on awareness, accessibility, affordability, and adoption. With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing. It is a race between humans and the virus, rather than between countries or pharmaceutical companies.

Conclusion

Putting an end to this viral disaster with a vaccine has led to a global vaccine race to coherently extinguish Covid-19. Each week brings news on early success, low cost, fast track results, promising effects because of vaccine optimism. There is too much uncertainty that continues to be pondered upon. The vaccine won’t extinguish the disease itself but offer protection and immunity. It certainly will not immediately return life to “old normal”. The virus is too widespread but the vaccine could make Covid-19 easier to live with and prevent severe cases.

Finally, there seems to be a ray of hope amidst this tunnel of misery!

This image has an empty alt attribute; its file name is Picture2.png
Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent, and nurturing strong relationships with external stakeholders. Holding Senior Management Position for the last 20 years and involved in strategic decision making. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

Sunaina Anand

Dr. Sunaina Anand, Pharm. D is a Clinical Pharmacist. She currently serves as Medical Affairs Executive in IntelliMed Healthcare Solutions. She previously interned in Tata Memorial Hospital and Columbia Asia Hospital, Bengaluru.

Related Post: Insights+ KOL Articles: Immunity & Pregnancy: Unique and Complex

Image Source: DNAIndia




Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots:

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Click here, Click here ­to­ read full press release/ article | Ref: GSK, GSK | Image: WorldPharma Today

Related News: Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine




US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine

The US government has selected a potential vaccine from Sanofi and GlaxoSmithKline for its Operation Warp Speed COVID-19 vaccine development initiative, committing up to $2.1 billion for an initial 100 million doses.

The collaborative effort with the US government will accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine.

Developed by Sanofi in partnership with GSK, the vaccine is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.

It is one of 139 vaccines that have yet to make it as far as the clinic and none have been approved by any regulator.

There are 26 vaccines in human trials and by the World Health Organization’s reckoning the most advanced is a phase 3 candidate from AstraZeneca and Oxford University.

More than half of the $2.1 billion from Sanofi and GSK comes from the US government and will support further development of the vaccine, including clinical trials.

The remainder will be used to scale up manufacturing and delivery of the first 100 million doses.

The US government has a further option for the supply of another 500 million doses in the longer term.

Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a phase 1/2 study to start in September, followed by a phase 3 study by the end of 2020.

If data are positive, the companies can request US regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to a billion doses per year globally.

The companies added they are committed to making the vaccines available globally, and there are “active discussions” with global organisations and the European Commission.

France and Italy are on the negotiation team and are discussing supplying European countries from Sanofi’s and GSK’s European industrial network.

The partners also plan to provide a significant portion of total worldwide available supply capacity in 2021/22.

The post US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine appeared first on .

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Shots:

  • The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19
  • Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are expecting the approval in H1’21
  • The vaccine is deploying Sanofi’s S-protein COVID-19 antigen together with GSK’s adjuvant technology. Both the companies are scaling up manufacturing of the antigen and adjuvant to produce up to 1B doses per year

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: PharmaShots

Related News: Sanofi and GSK Collaborate to Develop Adjuvanted COVID-19 Vaccine




Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots:

  • The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
  • The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
  • Assuming clinical success, companies expect to seek regulatory approval as early as Oct’2020. Following the approval, the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing Abs and has received the US BT designation

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: StraitTimes

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19




Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab.

The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed mRNA-1273 in April.

Moderna has decided to expand the number of participants in a phase 3 trial after discussions with the FDA and with the Trump administration’s Operation Warp Speed.

The total number of patients involved in the phase 3 trial will be 30,000, and total funding awarded is around $955 million.

The phase 3 COVE study is expected to begin today and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

After a review by the FDA, the trial will involve a 100 microgram dose and the endpoint will be prevention of symptomatic COVID-19 disease.

Key secondary endpoints include prevention of severe COVID-19 disease – defined as the need for hospitalisation – and prevention of infection by SARS-CoV-2.

Moderna says it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021 thanks to its manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Moderna’s vaccine is based on cutting-edge but unproven technology, which uses a strand of mRNA to instruct the patient’s body to make copies of the “Spike” protein found on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

It’s hoped that this will prime the immune system to swing into action and neutralise the virus should patients become infected.

According to a regularly updated document from the World Health Organization, there are now 25 potential COVID-19 vaccines in clinical development.

A candidate developed by China’s Sinovac is at the top of the list, although Moderna’s drug may move up in the WHO’s reckoning following the latest development.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Moderna gets further $472m as expanded phase 3 COVID-19 trial begins appeared first on .

UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva

The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials. 

There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results check out. 

The announcements came as the scientific community held its breath waiting for news of a potential vaccine from AstraZeneca and Oxford University, with trial results due to be published by The Lancet medical journal. 

According to the latest estimates from the World Health Organization there are 23 potential vaccines in clinical trials and 140 in preclinical development. 

The UK has secured 30 million doses of an experimental vaccine from BioNTech/Pfizer, and a deal in principle for 60 million doses of another vaccine from Valneva with an option of 40 million more doses if trials show it to be safe and effective. 

Later this month BioNTech and Pfizer are due to begin phase 2b/3 development of a vaccine candidate selected from four in early clinical trials. 

France’s Valneva said the vaccine could be manufactured at its facility in Livingston, Scotland, and in Solna, Sweden. 

Financial details were not disclosed. 

The deals follow a previously announced agreement with AstraZeneca for 100 million doses of the vaccine being developed in partnership with the University of Oxford. 

The AZ/Oxford vaccine is one of the most advanced in clinical development, with a phase 3 trial ongoing and results from a phase 1 trial due very soon. 

The government has also helped to fund a coronavirus vaccine developed by a team at London’s Imperial College, which is in an early clinical trial. 

GSK announces vaccine tie-up with CureVac 

GlaxoSmithKline separately announced a strategic collaboration with Germany’s CureVac to collaborate on mRNA vaccine and monoclonal antibody research in infectious diseases. 

The deal will not include CureVac’s COVID-19 vaccine, but will see the UK pharma make an equity investment of £130 million ($161 million) and an up front payment of £104 million ($129 million). 

CureVac will be eligible to receive development and regulatory milestone payments of up to £277m ($343 million), commercial milestone payments of up to £329m ($408 million) and tiered royalties on product sales.   

The agreement for the research, development, manufacturing and marketing of up to five mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. 

The companies said they will combine their knowledge of mRNA technology to develop vaccines against infectious diseases. 

Although the technology is not yet proven, many of the COVID-19 vaccines are based around mRNA technology that tells the body to produce antigens expressed by a virus. 

This in turn produces an immune response, and RNA vaccines have the advantage of being faster and cheaper to produce than with older techniques, allowing companies to respond quickly to emerging diseases. 

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Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout

Press reports suggest that there is good news about AstraZeneca and Oxford University’s COVID-19 vaccine due from an early stage trial in the coming days – but the focus is moving on how to get the in-depth safety and efficacy results needed to get the jab formally approved. 

According to the press reports, the phase 1 trial results suggest the vaccine produces an immune response including both antibodies and T-cells with few side-effects.

Further details are due to be published in The Lancet, according to the journalist Robert Peston, who broke the story. 

This twin effect could be the key to lasting immunity against the virus, with the T-cells able to attack the virus even if the body has stopped producing antibodies that neutralise it. 

AZ’s vaccine is one of the front-runners in a growing list of vaccines that have been rushed into clinical trials, when development began almost immediately after Chinese scientists published the virus’s genetic details in January. 

The vaccine is already in phase 3 development and the company is busy recruiting tens of thousands of people in the UK, Brazil, South Africa, and the US. 

According to The Guardian, the next step is to begin a controversial “challenge trial” where healthy subjects are given the vaccine and then exposed to the virus to test to test the levels of protection it confers. 

These trials are conducted in a lab and can be completed in a few weeks, requiring far fewer people. 

This is important because in countries where lockdown measures have been successful in controlling the spread of the SARS-CoV-2 virusit is becoming difficult to gather the data showing whether the vaccine is effective or not. 

Professor Adrian Hill, director of Oxford University’s Jenner Institute, told The Guardian that scientists are already preparing the trial and aim to get it up and running by the end of the year. 

He said: “This might be in parallel or might be after the phase three trial is completed. They’re not competing options, they’re complementary.” 

The Oxford team is among a growing group of scientists who argue that human challenge is justified given the low risk of serious complications or death for healthy people in their twenties. 

The World Health Organization has already produced guidance on challenge trials that suggests that risk of death from COVID-19 is approximately one in 3,000, around the same for live kidney donation. 

Hill said the risk is “so low that it’s very difficult to measure” and is among the signatories of an open letter from US-based campaign group 1Day Sooner, which is promoting challenge trials to accelerate development of a COVID-19 vaccine. 

Other signatories include the Nobel laureate and biologist Sir Richard Roberts, the renowned surgeon and former health minister Lord Darzi. 

Feature image courtesy of Rocky Mountain Laboratories/NIH

 

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No Approved Drug or Chemical For Prevention and Treatment of Coronavirus

The health authorities have time and again requested people not to take any drug or medicines by themselves in an attempt to cure coronavirus. When something is available for the treatment of COVID-19, it will be publicly announced by the World Health Organization (WHO).

The WHO is already coordinating with the pharmaceutical companies and researchers currently working on the development and evaluation of medicines for COVID-19.

People have been taken by myths that taking malaria drugs or chemicals such as methanol, ethanol, and bleach can prevent or cure coronavirus. However, that is not true.

Chemicals such as methanol, ethanol, and bleach are extremely poisonous and not fit for human consumption. Drinking such fluids can lead to disability and in worse cases, even death. While these chemicals are sometimes used in diluted form to kill viruses on the surface of metals, tiles, and other objects, drinking it only harms the internal organs and has to effect on the virus itself.

The best way to protect yourself against the virus is, therefore, to maintain proper hygiene and follow the norms of social distancing. People are requested to clean their hands regularly using handwash or use an alcohol-based sanitizer. They should avoid touching their mouth, face, nose, and eyes. A facial mask must be worn when in public and distance should be maintained from others.cot

It is wise to disinfect objects and surfaces that are touched regularly at home or the workplace using diluted bleach or alcohol. This will kill the bacteria and viruses and prevent further transmission of COVID-19.

Source: WHO

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