Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio.

Approvals for injectable vaccines for COVID-19 are starting to build, but non-injectables like oral and intranasal vaccines could be required if the pandemic is to be fought across all areas of the globe, according to Wayne Channon, the UK firm’s chairman.

“Non-injectables remove the need for health professional-led immunisation programmes, making widespread vaccine roll-outs quicker and easier and more affordable,” Channon told pharmaphorum.

“They also offer the potential for self-administration at home rather than in a health setting, making compliance with booster dosage potentially higher.”

ImmunityBio’s hAd5 candidate – using iosBio’s technology – has already shown encouraging preclinical results in non-human primates using an initial injection followed by two oral booster doses.

An injectable/oral ‘prime and boost’ regimen is in a phase 1b study due to conclude in November, according to the clinicaltrials.gov database, and ImmunityBio has said it is also recruiting patients for a phase 2/3 trial.

In time, it may be possible to deliver the entire immunisation course by the oral route, according to iosBio, while ImmunityBio has suggested the oral candidate could be used to provide a boost to other injectable vaccinations.

One of the primary advantages of this approach is that the oral vaccine capsules are stable at room temperature, which means they do not require cold chain storage. They are also cheaper to produce and store and can be distributed across the globe easily – all without the need for specialised equipment or personnel – according to iosBio.

“This is particularly important in developing countries, where access to cold-chain is limited,” said Channon.

There are other theoretical advantages as well. For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens.

“This can render the repeat administration of that vaccine as a booster, or a vaccine against a different infectious disease using the same viral vector, ineffective,” according to Channon.

The lack of anti-vector immunity in the gastrointestinal (GI) tract means repeat dosing with vaccines based on iosBio’s tech is possible, he suggested, because of the natural level of tolerance in the gut that avoids generating an immune response to food, for instance.

“This allows the same vector to be repeatedly orally administered and re-used for multiple vaccine programmes.”

ImmunityBio – led by billionaire surgeon and Nantworks and NantKwest founder Patrick Soon-Shiong – isn’t the only company looking at non-injectable COVID-19 vaccines.

Vaxart said in November it had completed enrolment in a phase 1 trial of its oral COVID-19 vaccine VXA-CoV2-1, having reported viral load reduction and antibody responses in a COVID-19 hamster challenge model. Symvivo also has an oral candidate in a phase 1 study which started last November.

Altimmune meanwhile is taking a different tack with its single-dose intranasal candidate AdCOVID, which had been due to generate initial clinical study results in the next few weeks but was placed on a clinical hold by the FDA last month after a request for more manufacturing data.

Soon-Shiong said that oral vaccines could have another key advantage as they stimulate mucosal, systemic and T-cell immune responses.

“As we see multiple mutations in the SARS-CoV-2 spike protein, there is an urgent need for a vaccine that not only offers immediate protection but also activates T-cells to clear the virus,” he said.

ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

That means it could “potentially serve as a universal boost to current vaccines that focus only on the monovalent S protein, as well as address future mutations of the S protein,” according to Soon-Shiong.

ImmunityBio and NantKwest announced last month they will merge into a single company focusing on  immunotherapies and cell therapies for cancer and infectious diseases.

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EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month.

The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting on 29 January, and if all goes well it could be authorised on that day, according to the regulator.

The European Commission will then fast-track its decision-making process, says the EMA, with a view to granting a conditional marketing authorisation “within days”, a timeframe which was welcomed by Commission President Ursula von der Leyen.

AZ’s AZD1222 shot – which was developed with Oxford University – was cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December, and since then it has also been given emergency approval in several other countries including India.

The filing comes as the EU is facing criticism for the slow roll-out of its coronavirus vaccination programme as infection rates soar in the 27 member states.

While individual EU countries make the decisions about who to vaccinate, the Commission is coordinating the acquisition and allocation of supplies, and there have been complaints the process is taking too long.

The US and Britain have both vaccinated 1%-2% of their populations, according to an Economist report citing figures from the Our World in Data website, while Israel is leading the field at 16%. In contrast, Germany has managed just 0.4%, France didn’t cross the 1,000 threshold until 4 January, and the Netherlands only started vaccinating until 6 January.

So far the EMA has conditionally approved two coronavirus vaccines – Pfizer/BioNTech’s Comirnaty last month and Moderna’s candidate last week – and swift approval of the AZ vaccine should allow an acceleration in vaccination rates in the EU.

As it stands, the UK has vaccinated more people than the entirety of the EU combined, with the latest government figures indicating 2.3 million people have now received the first of two required doses, saying it plans to immunise all adults in the country by the autumn.

So far the effect of vaccination is imperceptible, however, as the UK recorded more than 46,000 new cases of COVID-19 yesterday, and 529 deaths, with NHS capacity creaking under the weight of over 32,000 people hospitalised with the infection.

The EU has 400 million doses of the AZ vaccine on order, part of a procurement programme that so far extends to 2.3 billion doses.

Last week the Commission said it intended to order an additional 200 million doses of the BioNTech/Pfizer, with the option to acquire another 100 million doses, taking its total to 600 million doses.

It has also agreed deals for the supply of 160 million doses of the Moderna shot, 400 million apiece for candidates in testing at Johnson & Johnson and CureVac, and 300 million of a Sanofi/GlaxoSmithKline candidate that has been delayed by clinical trial snags.

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Moderna’s COVID-19 vaccine is third approved in UK

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks.

Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after Pfizer/BioNTech’s Comirnaty, which got the nod in December.

The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

That means for now, the country’s immunisation programme will continue to rely on Comirnaty and the AstraZeneca/University of Oxford shot approved just before the New Year.

Around 1.5 million people in the UK have received at least one dose of either Pfizer/BioNTech or AZ vaccines, and that includes around a quarter of the over-80s age bracket who are particularly vulnerable to COVID-19.

The government’s target is to vaccinate 15 million people – around 22% of the total population – by the middle of next month.

The UK is facing a marked escalation in cases however, with the attest daily figures showing 68,000 new cases and 1,325 coronavirus-related deaths, and with a more transmissible strain of SARS-CoV-2 threatening to overwhelm the NHS.

The latest vaccine approval was welcomed by NHS Confederation chief executive Danny Mortimer, but he also stressed that “it does not mean the COVID-19 crisis today is over, especially as a major incident is declared in London, hospitalisations for coronavirus continue to rocket, and as many as one in 50 people are now infected.”

He went on: “It will…be weeks and months until the NHS feels the benefit of the vaccination programme.”

Moderna’s shot claimed conditional EU approval earlier this week, and the first supplies will start to arrive in Europe next week, according to Moderna. The European Commission has ordered 160 million doses, but Brexit means the UK will not benefit from the EU’s allocation and rollout plans.

Meanwhile, mRNA-1273 was also granted emergency use authorisation by the FDA on 18 December, with the US scheduled to receive 20 million doses by the end of 2020. Moderna has also said it aims to make 100 and 125 million more doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US

The approval is based on trials showing mRNA-1273 had 94% efficacy in preventing disease, including in the elderly, roughly the same as the Pfizer/BioNTech shot and a little better than the 70% protection rate seen with AZ’s candidate.

The Oxfam charity welcomed that the UK now has more than enough vaccine on order to protect the entire population during 2021, but called for vaccine developers to share the science and technology behind them worldwide so less well-off countries don’t miss out.

“Nine in 10 people in the poorest countries are set to miss out on a vaccine unless the UK government and companies like Moderna urgently shift position,” said Oxfam’s health policy manager Anna Marriott.

“A failure to act is not just wrong but self-defeating and short-sighted – as long as the virus is allowed to spread in other parts of the world, public health and economic recovery in the UK will continue to be under threat,” she added.

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Bayer joins the COVID-19 vaccine push, backing CureVac shot

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped.

Bayer has joined forces with the German biotech to support the development and supply of CVnCoV, an mRNA candidate using a similar technology to the Pfizer/BioNTech and Moderna jabs, with the drugmaker saying it will help CureVac produce “several hundred million doses”.

CureVac has been working steadily on CVnCoV over the last few months as the spotlight was trained on candidates originated by BioNTech, Moderna and AstraZeneca, which were a little further ahead in development, but began its own phase 2b/3 study in mid-December.

It’s hoping for interim results from that in the first quarter of this year, which if positive could be followed by rolling regulatory submissions and – potentially at least – emergency approvals sometime towards the late spring/early summer.

The trial is assessing the safety and efficacy of CVnCoV in adults of various ages and once fully enrolled will include more than 35,000 participants in Europe and Latin America.

It aims to demonstrate the efficacy of CVnCoV in preventing first cases of confirmed COVID-19 of any severity, as well as preventing moderate to severe disease, in participants who have never been infected with the SARS-CoV-2 virus.

The European Commission – which has just approved the Moderna vaccine and previously gave a green light to the Pfizer/BioNTech shot – already has an order in for 405 million doses of the CureVac vaccine. It gave CureVac €75 million in funding to develop CVnCoV last July, adding to around €100 million provided by the German government in 2020.

The biotech would likely struggle to supply without the help of its new big pharma partner, although it has been expanding its production capacity in the last few weeks with the help of contract manufacturers like Wacker and Fareva.

Bayer said it will contribute in areas like clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain performance to help get the vaccine to the public as quickly as possible.

“We are highly committed to making our capabilities and networks available to help end this pandemic,” said Stefan Oelrich, president of the German group’s pharma division.

Bayer is providing assistance to CureVac primarily in the EU and some other markets, where the German biotech will be the marketing authorisation holder, but has an option to seek approval of CVnCoV on its own account in countries outside Europe.

CureVac has previously said however that it does not intend to introduce its vaccine in the US – at least while the pandemic is ongoing – because the government there has already ordered enough supplies of rival jabs to immunise the entire population.

At last count, there are more than 60 coronavirus vaccines at in clinical development around the world, with another 170 in preclinical testing, according to the World Health Organization (WHO).

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AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.

The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.

The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.

The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.

Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.

He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”

The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.

AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.

Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”

He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.

In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.

The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.

Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.

The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.

The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.

“It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.

“We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”

The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.

EU orders another 100m doses of Comirnaty

The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.

Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.

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Vulnerable should all get COVID-19 shot before summer, says NHS chief

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers.

The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.

There are around 25 million people classed as vulnerable due to their age or health conditions, and hitting that target will likely rely on the much-anticipated approval of the AstraZeneca/University of Oxford COVID-19 vaccine, said to be coming this week.

The UK has ordered 100 million doses of the AZ vaccine, which unlike the Pfizer/BioNTech shot can be stored and transported at normal temperatures, making it easier to distribute. Around 40 million doses are due to be delivered before the end of March. A third shot from Moderna isn’t expected to be available in the UK until well into next year.

The Pfizer/BioNTech vaccine – which was approved by the EU last week – is being delivered via a network of more than 80 hospital hubs and over 500 GP-led vaccination centres, as well as in care homes in the UK.

That will likely have to be expanded even further if the AZ vaccine is approved and as the immunisation programme gathers pace.

Stevens’ forecast – delivered to staff at a vacciination centre – came alongside a warning that NHS workers are “back in the eye of the storm”, with the number of coronavirus patients in hospitals higher than at the peak of the first wave.

There were around 20,500 hospitalised cases as of this morning, above a peak of just under 19,000 as the first wave hit in April. The UK also recorded a record number of lab-confirmed new cases yesterday at more than 41,000, although that figures reflects a higher level of testing nationally.

At the same time, the new, more transmissible variant of SARS-CoV-2 that was first identified in the UK has been detected in more than 20 other countries around the world, including several EU member states, India, Canada, Japan and Hong Kong.

The leading vaccine developers have said there is no reason their shots will not work against the new variant.

So far there is little evidence of “anti-vaxxer” resistance to the vaccine in the UK. However, in Spain – where more than a quarter of people said they would not take the vaccine in a recent survey – the health ministry has suggested it will set up a registry of people who refuse to be vaccinated and share it with other EU members.

The European Commission has said it expects to deliver 200 million doses of the Pfizer/BioNTech vaccine to EU countries by September 2021.

Novavax vaccine starts US phase 3

Meanwhile, another COVID-19 vaccine has entered the late-stage testing phase in North America. US biotech Novavax has started a phase 3 trial of its recombinant protein-based shot NVX-CoV2373 in the US and Mexico, adding to an ongoing phase 3 trial that started in the UK that is due to read out next year.

The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

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Moderna’s COVID-19 vaccine is second for US after FDA green light

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee.

The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved shot which started to be administered a few days ago.

The emergency use authorisation (EUA) for mRNA-1273 came the day after the FDA’s advisory panel voted 20-0 with one abstention that the benefits of the vaccine outweighed the risks for people aged 18 and over.

Moderna said delivery of supplies of mRNA-1273 will begin immediately, and reiterated its intention to provide 20 million doses to the US government out of its total order of more than 200 million before the end of this month.

The biotech now expects to have between 100 and 125 million doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US.

On Friday meanwhile, the European Commission said it had exercised an option for an additional 80 million doses of Moderna’s product, taking its total order to 160 million doses. The UK has ordered seven million doses, Japan 50 million and South Korea 20 million.

The new supplies come as a quarter of a million new cases are being recorded each day in the US, the highest national rate in the world, with daily deaths averaging around 2,500 in the last couple of weeks.

Some US states re already saying they are unable to get access to promised supplies of Pfizer and BioNTech’s BNT-162b, as federal officials suggested manufacturing issues were at risk of holding up supplies of the shot – although that has been disputed by Pfizer. The US government’s objective is to have 100 million people vaccinated by April.

“It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause,” said Francis Collins, director of the US National Institutes of Health (NIH) which carried out clinical trials of mRNA-1273 and also contributed a technology used to stabilise the jab.

“To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering,” he added.

Moderna’s vaccine should be easier to distribute than the Pfizer/BioNTech shot as it requires temperatures of around -20 C for shipping – similar to a normal freezer – rather than -70 C.

The company has also updated its handling guide for the distribution for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8 C, noting that “this important update eases the logistical burden of transporting the vaccine to more remote locations and ensures that the barriers to being vaccinated are lowered.”

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Scientists and medics turn to TikTok to reassure public on vaccine safety

Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics.

The social media platform, which allows users to share short and often frivolous video clips, has a growing number of experts using it to communicate important information to a broad audience, and particular teenagers and young adults.

One such scientist is Dr Anna Blakney (pictured above left), who is working on the COVID-19 vaccine project underway at Imperial College London in the UK and has attracted an impressive 205,000 followers.

She told the BBC that her approach on TikTok is “come for the entertainment, but stay for the science.” Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval.

Dr Austin Chiang

Another is Dr Austin Chiang, a gastroenterologist and the chief medical social media officer at Jefferson Health in Philadelphia, who said in an interview with the New York Times that covering vaccine-related topics on TikTok can be a minefield.

“When we talk about vaccines as health professionals, people who are vehemently anti-vaccine can take it out of context for their agenda. That makes me hold back sometimes,” said Chiang.

“The approach that I try to take is to leave room for the grey. If you say vaccines don’t cause any harm and are the best things in the world, it can alienate people who are vaccine hesitant. If we instead acknowledge that there are risks just like anything else in medicine and life, it’s a more effective message.”

TikTok itself meanwhile says it has taken steps to make sure its users have access to reliable information about the pandemic, which will be stepped up as immunisation programmes start in the UK, US and elsewhere.

Kevin Morgan, head of product and process, Europe, at the social media firm, notes in a blog post that in January it introduced an in-app notice so that when users searched for hashtags related to the pandemic, they would be provided with easy links to the World Health Organisation’s website and the British Red Cross.

The following month it rolled out an information hub in-app to provide the TikTok community with access to accurate information, which has been viewed 2 billion times since June and will be updated on 17 December with new information on vaccines

“Additionally, we will soon introduce a new vaccine tag to detect and tag all videos with words and hashtags related to the COVID-19 vaccine,” says Morgan.

“We will attach a banner to these videos with the message ‘Learn more about COVID-19 vaccines’,” which will redirect users to “verifiable, authoritative sources of information.”

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FDA backs Moderna COVID-19 shot ahead of emergency use vote

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%.

The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency green light last week, and ahead of an expert panel due to consider Moderna’s shot on Thursday.

If the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) agrees with the agency’s assessment it could be available before the end of the week, accelerating the pandemic immunisation programme.

Like Pfizer/BioNTech’s BNT-162b, Moderna’s mRNA-1273 is based on messenger RNA coding for the SARS-CoV-2 spike protein, and will be administered in a two-dose regimen given a few weeks apart.

The FDA says no specific safety concerns with mRNA-1273 have been seen in the 30,400-patient COVE trial that underpins the EUA application, with minor effects like fever, headache and fatigue common but manageable, a serious side effects rare.

The overall 94.5% efficacy rating two weeks after the second dose is in line with interim data from the trial, although the FDA notes that it seems to be less effective in older people.

For the 18 to 64 age group efficacy comes in at 96%, but drops to 86% in the over-65s – both values are  way above the threshold that should be needed to support emergency use during the pandemic.

The shot also worked equally well in white, black and Hispanic subjects, men and women, and those with conditions like obesity and diabetes that increase the risk of severe COVID-19.

Importantly, there was also some preliminary data pointing to a reduction in asymptomatic SARS-CoV-2 infections – something that hasn’t yet been demonstrated with other vaccines – as well as prevention of severe disease.

All told, 38 trial participants in the placebo arm of the trial tested positive for asymptomatic COVID-19 at the time of their second dose, well above the 14 positives in the mRNA-1273 arm.

If the VRBPAC votes in favour of mRNA-1273 shipments are expected to begin within 24 hours, and Moderna has said it expects to be able to provide up to 6 million doses in the initial rollout, adding to around 3 million doses of the Pfizer/BioNTech jab.

The first doses of BNT-162b are being used to treat healthcare workers and elderly people in care homes, and it will be many months before vaccinations are available for all America’s 330 million population. Both vaccines will be provided free of charge to recipients.

The federal government has already signed supply agreements with Moderna and Pfizer/BioNTech for 300 million doses in 2021, enough to dose 150 million people. mRNA-1273 requires less intensive refrigeration that BNT-162b, so could be more suitable for distribution to more remote areas of the US.

There is also hope that vaccines from Johnson & Johnson and AstraZeneca could also be available in the first quarter of 2021.

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Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday.

Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses earmarked for  healthcare workers and elderly.

Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.

It’s likely to be months before all eligible healthcare workers for the first wave receive vaccinations. Hopeful eyes are already turning to the Moderna’s mRNA-1273 vaccine, which is scheduled to be reviewed by FDA advisors on Thursday, to help boost available supplies.

The first nursing home residents aren’t expected to start receiving their doses until next week, according to Army General Gustave Perna, chief operating officer for Operation Warp Speed, the US vaccination task force.

The immunisation programme comes as hospitals around the country say they are already struggling to cope with the influx of COVID-19. The US has the highest death toll from the disease worldwide, ahead of Brazil, India and Mexico, and there are fears of a further spike as the holiday season gathers pace.

The US government is predicting that 20 million Americans will have received at least one of the two doses of the vaccines by the end of the year, with another 30 million set to be immunised during January and another 50 million by the end of March.

President Trump took a break from his relentless tweeting about alleged election fraud to briefly acknowledge the milestone on the path to recovery from the pandemic.

Canada also gave the first doses of BNT-162b to healthcare workers yesterday, a week after the UK started the ball rolling on its own vaccination programme – the first to get started in the world.

Because BNT-162b is made from RNA, it has strict temperature requirements and has to be stored at -70 C in dry ice to prevent it from breaking down, although it can be kept at regular refrigeration temperatures temporarily – around three days – after being defrosted for administration.

That will pose a logistical challenge for all countries, requiring a massive and carefully controlled shipping operation as doses come off the production line at Pfizer’s facility in Michigan.

Around 5 million doses of Moderna’s vaccine could be ready to ship straightaway if the FDA gives a green light, possibly as soon as Friday, with distributor McKesson handling that roll-out. Moderna’s shot is a little easier to handle as it only needs to be kept at -20 C.

Meanwhile, Operation Warp Speed’s chief executive Dr Moncef Slauoi also suggested yesterday that Johnson & Johnson could get approval for its shot in late January or early in February, while AstraZeneca may be in a position to seek FDA approval as early as February.

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Cyberattack targets EMA, hacks COVID-19 vaccine data

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed.

In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.

Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

Responding to fears that the review could be delayed, the company said it had been assured by the EMA that the timeline should not be affected. The agency has indicated it should complete its review by 29 December.

BNT-162b is already approved in the UK and Canada, and the first UK patients started to receive the shot on Tuesday this week. The EMA is also reviewing another vaccine from Moderna, but at the moment it’s not clear if data from that programme has also been compromised.

“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed,” said BioNTech in a statement on its website.

It added that it had publicised the breach “given the critical public health considerations and the importance of transparency”.

The cyberattack came just days after international enforcement agency Interpol warned that organised criminals may try to target COVID-19 vaccine supply chains, for example by falsification, theft and illegal advertising of unlicensed shots.

Europol meanwhile warned earlier this year that criminal networks are exploiting the COVID-19 pandemic with a surge in cybercrime, targeted thefts and counterfeiting, including attempts to target organisations through business email compromise (BEC), which can be used to harvest sensitive data, siphon off funds or damage its reputation.

There’s no indication yet who was behind the EMA hack, but a volunteer group set up to tackle cybercrime related to COVID-19 – CTI League – has suggested that one motivation could be to uncover details about the supply and distribution of vaccines.

The group’s found Marc Rogers told Reuters that information “potentially significantly increases the attack surface for the vaccine”.

IBM recently said an email phishing campaign had targeted organisations linked to the Cold Chain Equipment Optimisation Platform (CCEOP) of Gavi, the international vaccine alliance, suggesting that the sophistication of the assault pointed to a nation state being the culprit.

“Without a clear path to a cash-out, cyber-criminals are unlikely to devote the time and resources required to execute such a calculated operation,” according to the tech giant’s Security X-Force.

There has also been reports that hackers linked to North Korea, South Korea, Iran, Vietnam, China and Russia have tried to steal information about vaccines, targeting pharma companies and other organisations involved in COVID-19 medicine R&D, according to the news agency.

In October, Indian pharma company Dr Reddy’s Laboratories, which is helping to conduct late-stage testing of Russia’s Sputnik V COVID-19 vaccine, said it had been hit by a cyberattack that disrupted its production facilities.

Sam Curry, chief security officer at Cybereason, is convinced that a nation state is behind the EMA attack, saying: “Cyberattacks on the global COVID-19 vaccine distribution network from nation-states China, Russia and North Korea are diabolical in nature and acts of war.”

While acknowledging the average person “might be asking themselves why nation-state actors…are deliberately sowing doubt and confusion around the world at the worst possible time,” Curry says there is tremendous value in interfering with the distribution of COVID-19 vaccines.

“A COVID-19 vaccine is a strategically valuable asset to nation-states; whoever gets a vaccine distributed first has an economic advantage. It is the ultimate IP with immediate value. It is like having an oil rush, a data advantage or territorial gain in older real political terms.”

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Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying.

The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands of children being born with birth defects in the 1960s.

That ignores the fact that the thalidomide tragedy itself was responsible for the introduction of evidence-based medicine and reforms to the regulatory system that keep patients safe today.

While thalidomide is trending in the UK, it’s worth noting that many tweets are being posted by people slamming the #antivaxxers – a hashtag that is currently also riding high.

The Medicines and healthcare products regulatory Agency (MHRA) has been warning for some against anti-vaccine rhetoric that it fears could derail the coronavirus vaccination programme – which would be larger than any adult campaign carried out to date.

Pre-empting the backlash, MHRA’s chief executive Dr June Raine said at a Downing Street press briefing that despite the speed of its review, completed just three weeks after the final data were made available, no corners had been cut.

The vaccine had been approved after “an extremely thorough and scientifically rigorous review of all the evidence of safety, of effectiveness and of quality,” she asserted, adding: “The safety of the public will always come first.”

As the vaccine starts to be distributed, the National Institute for Biological Standards and Control (NIBSC) will be carrying out independent lab tests to confirm that every single shot that goes out meets the required standards for safety and quality, according to Raine.

Anti-vaxxers have been responsible for promulgating a series of fantastical rumours and conspiracy theories about coronavirus vaccines, including a persistent claim that vaccination will result in people being implanted with a microchip that will be used to track them.

Other false claims are that RNA-based vaccines like BNT162b can alter a recipient’s DNA and that the shots will contain tissue from aborted foetuses.

While some of these are frankly comical, the fear is that the spread of misinformation into mainstream media sources could result in fewer people taking up the opportunity to be vaccinated, undermining the programme.

Research published by the Vaccine Confidence Project – a unit of the London School of Hygiene & Tropical Medicine – found that misinformation around a COVID-19 vaccine induced a fall in the willingness to receive it among those who would otherwise “definitely” vaccinate.

VCP’s study found that only 54% of UK people would definitely have a COVID-19 vaccine – higher than the 41% seen in the US – with most of those who were reluctant citing safety concerns or a sense the threat posed by the pandemic had been overblown.

That’s already fewer than is required for herd immunity – a level of protection that would impact on virus transmission – but most worrying was that exposure to misinformation reduced the proportion of those definite responses by more than 6%.

“I hope that enough people take these vaccines, but I think it is going to be much more of a challenge than is recognised,” VCP director Heidi Larson told the Financial Times this week.

Speaking to the BBC today, Pfizer’s country manager for the UK, Ben Osborn said that “after the provision of clean water, vaccines are…the single most effective public health intervention we can make”. He also stressed that the study behind the approval was assessed by an independent panel with no links to Pfizer and BioNTech.

Health secretary Matt Hancock has also responded to questions about the anti-vax movement today, telling LBC radio that “the good news is that it’s not growing”.

“We monitor this very carefully and actually the number of people who want to have the vaccine is increasing,” he said

“The regulators are fiercely independent – they would not approve this if it wasn’t safe.”

800,000 doses of BNT162b have passed batch testing and should be ready within the next few days, and will be prioritised for elderly people in care homes and care home staff, followed by over-80s and health and care service workers.

The UK has ordered 40 million doses – enough for 20 million people – with several million doses expected to be available by year-end. Scottish leader Nicola Sturgeon said the first vaccines would be available in Scotland from Tuesday next week.

Twitter has also seen a debate about how the UK was able to become the first country in the world to approve the vaccine.

Hancock said the country was able to move quickly because of Brexit, but Raine emphasised in the press briefing that the approval was “made under provisions under European law which exist until January 1”.

The European Medicines Agency will meet on 29 December to decide if the safety and efficacy of Pfizer and BioNTech’s vaccine supports its approval.

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Moderna seeks COVID vaccine okay as data backs 94% efficacy

Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results for the shot.

The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 cases in the placebo arm and just 11 among those given the vaccine after two months of follow-up.

The efficacy rate is almost identical to an earlier readout after 95 confirmed cases of COVID-19 in COVE, which is being run by the US National Institute of Allergy and Infectious Diseases (NIAID), and the safety profile also looks clean, according to Moderna.

It also appears to prevent volunteers from getting very sick from the virus, as all 30 cases of severe COVID-19, and single coronavirus-related death, were in the placebo arm.

The FDA and EMA will now look at the results and see if the mRNA-based vaccine can be given a green light for widespread use, and according to Moderna the data will be discussed at a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 17 December.

Pfizer and BioNTech’s mRNA-based shot BNT162b was the first coronavirus vaccine to be submitted for emergency approval in the US on 20 November, but at the time of writing hadn’t yet been given a green light.

AstraZeneca and the University of Oxford’s adenoviral shot AZD1222 meanwhile has also been submitted for approval in Europe under the rolling review procedure, as well as in the UK. The company expects to file for approval in the US after the readout of a US trial in 40,000 patients that hasn’t yet generated results.

While AZD1222’s efficacy hasn’t matched the mRNA vaccines in trials so far, it will be cheaper and easier to distribute as it can be kept at standard refrigeration temperatures.

As it stands, the Pfizer/BioNTech shot has to be kept at -70 degrees Celsius – although the partners are testing stability at warmer temperatures – and Moderna has data suggesting its vaccine is stable for a month in standard refrigeration once taken out of a freezer.

AZD122 is expected to cost around $4 per dose, compared to approximately $20 for BNT162b and $32-plus for mRNA-1273.

Russia’s adenoviral shot Sputnik V meanwhile has a claimed efficacy of 92%, will cost less than $10 a dose, and can also be stored at standard fridge temperatures.

Moderna said that it will also seek prequalification and emergency use listing from the World Health Organization (WHO), which provide a route to market for vaccines, drugs and other healthcare products that meet pressing public health needs, particularly in low- and middle-income countries.

As with the other vaccine data readouts, there are still a lot of unanswered questions, including whether the shots can cut viral transmission rates – including asymptomatic transmission – how long protection may last, the impact on hospitalisation rates, and long-term safety.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” commented Moderna’s chief executive Stéphane Bancel.

The US biotech has reiterated its expectation of having 20 million doses of mRNA-1273 available by the end of the year, which is earmarked to supply the US, which has ordered 100 million doses. 50 million doses are also due to head to Japan, and 20 million to Canada, while the UK has just raised its order to 7 million.

Shares of Moderna were up more than 16% on the Nasdaq as the markets opened in the US.

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Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.

Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.

Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).

That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.

AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”

At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.

The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.

Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.

Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.

Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.

So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.

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UK eyes access deal as Moderna’s COVID-19 shot hits the mark

Moderna is the third group in a week to report encouraging phase 3 data with a coronavirus vaccine, saying today that its mRNA-1273 shot had an efficacy of 94.5% in the 30,000-patient COVE study.

The results set up an emergency use authorisation (EUA) filing in the US “within weeks” according to the company, and the UK government has also said it is now in active negotiations with the biotech to try to claim a share of the supply if approved.

The interim analysis from COVE comes after 95 confirmed cases of COVID-19 among the vaccine and placebo groups in the study, which was carried out by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) in the US.

That’s the same number of cases that prompted the readout of data from a trial of Pfizer/BioNTech’s BNT162b2 a week ago – another mRNA-based vaccine with a 90% efficacy rate – and rather more than the 20 cases used to give a 92% efficacy measure for Russia’s adenovirus-based Sputnik V candidate.

Pfizer chief executive Albert Bourla was among the first to congratulate Moderna on the encouraging data, tweeting:

In COVE, 90 cases of COVID-19 were seen in the control arm, compared to five in the mRNA-1273 group. There were also 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.

Moderna and the NIAID have also pointed to spectrum of COVID-19 cases in the study, saying that 15 of the 95 were people aged over 65, while 20 were from diverse communities including Hispanic/Latino, black/African American, and Asian American.

A UK government spokesperson said that “advanced discussions” are ongoing with Moderna to ensure UK access to the vaccine, suggesting that doses would become available in spring 2021 in the UK “at the earliest.”

There will be a queue for early access, however. Moderna said towards the end of last month that it had received $1.1 billion in deposits for mRNA-1273, with 100 million doses destined for the US, 50 million heading to Japan, and 20 million to Canada.

Moderna has previously said it expects to produce and ship around 20 million doses of mRNA-1273 to the US this year – a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

As with the other two vaccine data readouts there are still a lot of unanswered questions with COVE, including whether it can cut viral transmission rates – including asymptomatic transmission – and how long its protection may last.

As more cases of COVID-19 occur in the ongoing study, Moderna notes that the point estimate for vaccine efficacy could change. Nevertheless, there’s little doubt that having three separate vaccines claiming 90%-plus efficacy is a massive boost to hopes of widespread immunisation in 2021.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Moderna CEO Stéphane Bancel.

“We look forward to the next milestones of submitting for an EUA in the US, and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study,” he added.

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Russia claims 92% efficacy for Sputnik COVID-19 shot

In the second positive piece of COVID-19 vaccine news in a week, Russia’s Sputnik V candidate has been shown to be 92% effective at the interim point of a 40,000-patient study.

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

They say 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 coronavirus 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.

Sputnik V has already been approved in Russia ahead of the phase 3 trial results, getting a green light in August on the strength of early-stage data in 100 patients. Since then, around 10,000 people have received it and monitoring of those subjects “confirmed vaccine efficacy at a rate of over 90%,” according to the statement.

The update comes just a couple of days after BioNTech and Pfizer reported a 90% efficacy rate at 28 days with their mRNA-based candidate BNT162b2 from an evaluation of 94 cases in a phase 3 trial involving 43,538 subjects.

In both these cases only the top-line data is available, and medical experts are waiting anxiously for a full look at the data sets, to see for example if the vaccines are able to reduce the rate of severe COVID-19, prevent asymptomatic infection with SARS-CoV-2, and cut viral transmission rates.

It’s also not clear how well they work in different patient populations, such as older people, children and different ethnic backgrounds, and how long protection will last.

The Gamaleya Institute and RDIF says they will follow up all patients in the study for six months, after which final results will be reported. In the meantime, phase 3 trials of Sputnik V are also underway in Belarus, United Arab Emirates and Venezuela, with a phase 2/3 study on the go in India.

Russia’s minister of health Mikhail Marushko hailed the results, saying they show Sputnik V is “an efficient solution to stop the spread of coronavirus infection, а preventive healthcare tool, and this is the most successful path to defeat the pandemic.”

Requests for more than 1.2 billion doses of Sputnik V have already come in from over 50 countries, according to the RDIF, which says it has contracts in pace that will allow production of 500 million doses of V vaccine outside Russia every year.

In other news, the 60,000-patient ENSEMBLE trial of Johnson & Johnson’s coronavirus vaccine candidate has started to resume in Europe after a suspension caused by an unexplained illness in a test subject in October. The trial was cleared to restart in the US a few days later.

Meanwhile, Brazilian regulator Anvisa has suspended clinical testing of a shot being developed by China’s Sinovac Biotech after a “severe adverse incident” – reported to be  fatality – in the phase 3 CoronaVac trial being conducted in the country.

The study is also being conducted in Turkey and Indonesia, but dosing hasn’t been suspended int those countries, according to a BBC report.

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MHRA looks to AI to hunt for COVID-19 vaccine side effects

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”

The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

The company is a subsidiary of US group GenPact, which already offers an AI and machine learning based tool called Cora PharmacoVigilance that can be used to identify patterns in data to foresee potential side effects.

The contract from the Medicines and Healthcare products Regulatory Agency (MHRA) recognises that the timelines for the development of coronavirus vaccines has been accelerated so fast that a complete picture of their safety may not be available when they start to be used in widespread immunisation campaigns.

Former UK Prime Minister Tony Blair said this morning that the AstraZeneca/Oxford University adenovirus-based vaccine AZD1222 should be rolled as soon as possible – ideally in the month of November – as “it is essentially safe.”

He also called for experimental drugs being tested in the UK RECOVERY trial to be used in any hospitalised patients at risk of serious illness from COVID-19, in a foreword to a report on the pandemic published by the Tony Blair Institute for Global Change.

The MHRA told the Financial Times that based on historical vaccination data, it is expecting between 50,000 and 100,000 ADR reports for every 100 million doses delivered to patients over a six to 12 month period

The regulator also stressed that an ADR does not necessarily mean a true side effect has been observed, and AI would help spot any emerging safety signals.

The coronavirus vaccination programme would be larger than any adult campaign carried out to date, and the MHRA is concerned it could be derailed by “anti-vaccine social media activity and lobbying.”

The GenPact UK contract bypasses the usual “call for competition” tender process required by EU regulations, according to the MHRA, because if “reasons of extreme urgency”, and because it would not be feasible to “retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine.”

The agency also says in the contract announcement that its proposed SafetyConnect programme,  for pharmacovigilance and medical device safety monitoring would not be ready by the expected coronavirus vaccine launch.

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Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot.

The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call on which he also highlighted a new agreement to supply 50 million doses of mRNA-1273 to Japan in the first half of next year with the help of Takeda.

The Japanese deal adds to a 100 million-dose agreement with the US governments agreed in August, worth some $1.5 billion, as well as a 20 million order from Canada and others including a recent agreement with Qatar.

Bancel reiterated Moderna’s expectation of an initial data readout from the pivotal COVE trial of mRNA-1273 in early November, with the critical two-month safety follow-up on half the 30,000 enrolled subjects later towards the end of that month.

That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. In the meantime, rolling reviews are also underway in the UK and Canada and planned in the EU.

The $1.1 billion cash injection has been booked as deferred revenue by Moderna, and helped the company generate positive cash flow for the first time in its 10-year history.

The vaccine also sets up 2021 to be the “most important inflection year in Moderna’s history”, according to Bancel – not least because it has emerged as the test bed for the biotech’s entire drug development platform.

“We intend to reinvest the returns from the sales of the vaccine into our pipeline development and hope to bring more medicines to the market,” he said. “I believe that the long-term strategic implication are large.”

Moderna’s chief medical officer Tal Zaks said on the call that clinical results with mRNA-1273 to date indicate the shot is generally safe and well-tolerated – with flu-like symptoms and injection site reactions the most common side effect reported with the two-dose regimen.

He also stressed that neutralising antibodies rise quickly after a second dose, and are seen consistently in patients regardless of age – a positive result because the immune system tends to weaken with age and older people are those most at risk of dying from the coronavirus.

Last month, Moderna said it was slowing enrolment in COVE to make sure that older patients, younger people with chronic diseases, and subjects of African American, Hispanic/Latin and Asian descent were included in the trial population.

Hitting the data readout timeline depends on 53 cases of COVID-19 being diagnosed for the interim analysis, and with rates of infection climbing around the world that should be easier to achieve. Further analysis of the data will also be triggered COVID-19 cases reach 106 and then 151, the final threshold.

Moderna said it expects to produce around 20 million doses of mRNA-1273 ready to ship in the US this year, which is a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

The biotech has retained full control of its vaccine rather than partnering with a larger company, and has agreed to supply it to the US at a cost of $25 per dose.

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Vaccine sales recover at GSK in Q3, but lockdown fears weigh on shares

GlaxoSmithKline saw a recovery in its vaccine sales in the third quarter after a big hit in the second as a result of the COVID-19 pandemic, putting it back on course to meet the lower end of earnings guidance for the year.

The bounce-back wasn’t enough to ease investor worries however – with fresh lockdowns reported to be looming in various countries including France and Germany – and shares in the UK drugmaker were tracking down after the announcement.

Overall, group sales slipped 3% to £8.6 billion ($11.2 billion), mainly hit by falling vaccination rates, with pharmaceuticals down by the same margin to £4.2 billion, buoyed by respiratory and its two-drug HIV products.

Highlights included asthma drugs Trelegy (fluticasone furoate/umeclidinium/vilanterol) and Nucala (mepolizumab), which grew 26% and 29% respectively, injecting further upward momentum to GSK’s respiratory franchise.

Despite the recovery, vaccine sales still fell 12% compared to the previous year’s quarter to £2 billion. There were declines for shingles jab Shingrix and Bexsero to prevent invasive meningococcal disease offset by a rise in flu vaccine sales. Shingrix, which has been driving growth at the company of late, fell 30% to £374 million.

Governments have been trying to ramp up flu immunisation to reduce the burden of the disease on hospital admissions with a second COVID-19 wave building.

“GSK has responded well to a challenging operating environment this year with disciplined cost control and strong commercial momentum in key growth products,” said CEO Emma Walmsley.

GSK is working with Sanofi on a potential vaccine for the SARS-CoV-2 coronavirus, and Walmsley confirmed the company is on track to deliver on its pledge to produce a billion doses of the adjuvanted, recombinant protein-based shot by the end of 2021, assuming it gets the regulatory approvals it is hoping for in the first half of next year.

Ahead of the results announcement, GSK and Sanofi confirmed that 200 million doses of their COVID-19 vaccine had been committed to COVAX, a World Health Organisation (WHO) backed effort aimed at distributing COVID-19 vaccines fairly around the world.

“Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world,” said Roger Connor, president of GSK Vaccines.

“ We are proud to be working with Sanofi to make this…vaccine available to the countries signed up to the COVAX facility as soon as possible – this has the potential to be a significant contribution to the global fight against COVID-19.”

COVAX is aiming to make 2 billion doses of vaccine available by the end of next year. Sanofi and GSK initiated a 440-patient phase 1/2 study of their vaccine in September and expect initial results in early December. They hope to start a phase 3 study before the end of the year.

The two parts have already taken advance orders for 60 million doses of the vaccine with the UK government, and 100 million doses with the US in a deal valued at $2.1 billion.

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Russia’s COVID-19 vaccine filed with WHO, as MHRA reviews Moderna shot

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world.

The applications are for two WHO mechanisms, aimed at providing a route to market for vaccines, drugs and other healthcare products that answer public health needs, particularly in low- and middle-income countries.

The Russian Direct Investment Fund (RDIF) has filed the state-owned Gamaleya Institute’s Sputnik V (Gam-COVID-Vac) for emergency use listing (EUL) – a process set up in response to Ebola that provides a route to approval for use of medicines for public health emergencies by WHO member states.

It is also going after WHO prequalification, which mainly covers essential medicines and supports use by the UN and other non-governmental organisations.

Both mechanisms cover review of safety and efficacy data, as well as ensuring the product meets manufacturing and quality assurance standards. Gilead Sciences COVID-19 therapy Veklury (remdesivir) was added to the prequalification list earlier this month.

Russia has reportedly been discussing prequalification of the Sputnik V with the WHO since the summer. In a statement, the RDIF said WHO registration “will make the Russian vaccine available globally in a shorter time frame than usual procedures and will support global efforts to prevent the coronavirus infection.”

Approval would also allow Sputnik V to be included in the list of medicines used by international procurement agencies and countries to guide bulk purchasing of medicines.

The applications come after Russia approved Sputnik V in August, the first coronavirus vaccine worldwide to get a green light, and after the country said it has accepted orders for 200 million doses of Sputnik V from Brazil, India and Mexico. It has suggested it will be able to make a billion doses of the shot per year from 2021.

There has however been some debate about the lack of data behind the shot, and concerns that Russia rushed development to claim a political victory in the race to get a COVID-19 vaccine approved.

Preliminary results published in The Lancet last month covered just 76 people, which found an antibody response within 21 days and T-cell response within 28 days, with no serious adverse events recorded out to 42 days of follow-up.

It is in two phase 3 trials, including the RESIST study which has a target enrolment of 40,000 subjects and is due to generate results in the spring.

The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus. Immunisation requires two doses, with the Ad26-based shot given first and the Ad5 21 days later.

“We express our gratitude to WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages,” commented Kirill Dmitriev, CEO of the RDIF.

The WHO’s regularly updated listing of COVID-19 vaccines in development puts Sputnik V sixth out of 44 candidates that have advanced into human testing.

UK starts review of Moderna’s mRNA-1273

Separately, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has kicked off a rolling review of another late-stage coronavirus vaccine – Moderna’s mRNA-1273 – shortly after the US biotech completed enrollment in the phase 3 COVE trial.

The UK agency has started its review of the jab before the European Medicines Agency (EMA), but after a rolling review for mRNA-1273 was started in Canada.

The rolling submission allows regulators to start looking at available preclinical, manufacturing and clinical data in advance of the readout of COVE, potentially shortening the review time.

If COVE is positive and mRNA-1273 gets approved, Moderna has said 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.

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Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial.

It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus vaccine company to be ready to file for emergency use authorisation in the US.

As with all COVID-19 vaccines, Moderna will need two months of safety data following the final vaccine dose before it will be able to file for an EUA, but the milestone puts it just behind Pfizer and BioNTech in the race to that objective with a possible filing date in early December.

Shares in the company climbed nearly 5% after the announcement continuing an upwards trend that means the stock is now trading at almost four times its value at the start of the year.

The latest milestone follows a rolling reviews of mRNA-1273 in Canada, which allow the country’s regulator to start reviewing data as it becomes available, and Moderna is now gearing up to file via  similar mechanism in Europe.

Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

That includes 7,000 people aged over 65 and more than 5,000 younger people with chronic diseases that make them more likely to get severe symptoms like diabetes and obesity, while around a third of subjects of African American, Hispanic/Latin and Asian descent.

Last month, Moderna said it was slowing enrolment in COVE to “ensure the representation of…communities of colour, ” and on that measure it seems to have an advantage over Pfizer/BioNTech’s BNT162b2 vaccine, which completed phase 3 recruitment in mid-September but has only 25% ethnic minorities.

Studies have suggested that that black and minority ethic people are at higher risk of dying from COVID-19 than the rest of the population.

The study – funded with the help of $955 million of US government money – is comparing two 100 µg doses of mRNA-1273 given by intramuscular injection 28 days apart to a matched placebo, and the primary endpoint is the prevention of symptomatic COVID-19 disease 14 days after the second administration.

Like Pfizer/BioNTech and other coronavirus vaccine developers, Moderna has committed to ensuring that it has full safety and efficacy data available before filing for an EUA.

If COVE is positive and mRNA-1273 gets approved, Moderna has said 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 a manufacturing collaboration with Lonza.

Initially supplies will be much more limited of course, and the US has already placed orders for 100 million doses of mRNA-123 in a $1.5 billion deal agreed in August.

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AZ, J&J COVID-19 vaccine trials okay to restart in US

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.

Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of  its coronavirus candidate JNJ-78436735, which has also suspended after one study subject fell ill.

AZ confirmed the FDA’s move in a statement, saying that regulators in the US, UK, Brazil, South Africa and Japan have now said that trials of the Oxford University-partnered shot are safe to continue.

The FDA took a lot longer to reach its conclusion however, as recruitment into studies restarted just a few days after the halt elsewhere.

AZ chief executive Pascal Soriot said: “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

On 6 September, AZ said it had put trials of AZD1222 on temporary hold because of a potential safety issue involving one patient in the UK, who had become ill after taking the vaccine with what at the time was reported to be transverse myelitis – an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.

“It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” said AZ, which hasn’t confirmed the nature of the adverse reaction.

A report in the Wall Street Journal suggests that the FDA has reviewed two cases of potential neurological side effects in patients receiving AZD1222. One was subsequently found to be in a patient with MS, but the US regulator couldn’t either identify or rule out a clear link to the vaccine in both cases.

A death has also occurred in a patient enrolled onto an AZD1222 study in Brazil, although that has not been linked to the vaccine and is believed to have occurred in a subject who did not receive the shot.

AZ is now expecting to have results from the trials before the end of the year – analysts at Jefferies think it could occur in mid-November – and rolling regulatory  reviews of AZD1222 are already underway in some markets including the EU.

J&J meanwhile said that the independent data safety monitoring committee overseeing the phase 3 ENSEMBLE trial of JNJ-78436735 had found no clear cause behind a “serious medical event” – reported to be a stoke – in one subject that caused the study to be placed on hold earlier this month.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” said the drugmaker in a statement indicating the findings had been shared with the FDA. “There are many possible factors that could have caused the event.”

The suspension of studies for AZD1222 and JNJ-78436735 has put two coronavirus vaccines from BioNTech/Pfizer and Moderna in the lead in the US, with top-line efficacy results due within the next 4-5 weeks, although safety data will take a little longer to come in.

The resumption of the two stalled studies means that AZ and J&J will now not be too far behind.

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Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved

Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery if it clears phase 3 testing.

The output of the plant in Puurs should allow the partners to have 100 million doses of BNT162b2 ready for delivery by the end of the year, according to a Mail on Sunday report, which claims 40 million of those doses are destined for the UK.

As two doses of the mRNA-based shot are required to stimulate an immune response against the coronavirus, that would be enough to vaccinate 20 million people.

The COVID-19 shot started a rolling review at the European Medicines Agency (EMA) earlier this month – which involves the agency evaluating data as they become available rather than in one block – and that means approval could come shortly after the 44,000-patient trial readout which is due by the end of this month.

Video footage of vaccine vials coming off the production line have generated excitement and puts Pfizer and BioNTech in pole position to get the first COVID-19 shot approved.

Pfizer is predicting a longer timeline in the US than Europe however, saying it won’t be able to file for emergency use authorisation in the US until the third week of November – assuming trials go as planned of course.

While top-line data on efficacy could be ready this month, at least half the recipients of the shot in the trial will have to be followed for safety for two months after the second dose, and that will set back the EUA filing.

That timescale dashes any chance of a feelgood coronavirus vaccine story for Donald Trump as he campaigns for a second term as US President. Pfizer and BioNTech were among a group of nine COVID-19 vaccine developers who pledged not to launch before thorough tests are completed.

The federal government agreed an initial order of 100 million doses of BNT162b2 in July, with an option on up to 500 million, and Pfizer and BioNTech reckon they have the capacity to make 1.3 billion doses next year.

The Pfizer update comes as the UK’s deputy chief medical officer Prof Jonathan Van-Tam suggested that Oxford University and AstraZeneca’s AZD1222 shot – based on a different technology – could be available in the UK “soon after Christmas”.

That timeframe would allow vaccination of elderly and vulnerable people as well as key workers to begin in the New Year, according to an article in the Sunday Times. The comments were made at a joint Commons and Lords national security strategy committee meeting.

Chief scientific officer Sir Patrick Vallance told the panel that a vaccine is unlikely to be widely available until next spring, and reiterated his view that the SARS-CoV-2 coronavirus will become endemic. However, he suggested it’s level of threat could be reduced to that of seasonal flu if effective vaccines are available.

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Sanofi preps trials of second COVID-19 shot, as Russia approves another

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing.

The French drugmaker’s Sanofi Pasteur vaccines division says it is planning a phase 1/2 trial of the mRNA-based vaccine, called MRT5500, before the end of the year. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month.

There are already three other RNA-based vaccines in trials for COVID-19 from Moderna, Pfizer/BioNTech and CureVac, out of 42 candidates in clinical development, according to the World Health Organization’s latest update.

Among these, Pfizer/BioNTech’s BNT162b2 looks like it could claim the lead among the late-stage COVID-19 vaccine programmes, after safety issues halted trials of rival shots from Johnson & Johnson and AstraZeneca.

Data from a 195-patient phase 1 trial of BNT162b2 were published in the New England Journal of Medicine this week, showing that the shot stimulated neutralising antibodies to SARS-CoV-2 at a level similar or greater than those found in people who have recovered from infection with the virus.

Another vaccine – called BNT162b1 – was also effective in stimulating an antibody response but was associated with more systemic side effects, according to the trial investigators.

In preclinical testing involving mice and non-human primates, two doses of MRT500 also elicited a strong neutralising antibody response against SARS-CoV-2 that according to Sanofi were significantly higher than those observed in COVID-19 patients.

Sanofi and Massachusetts-based Translate Bio started to work together on the mRNA vaccine programme in March, and expanded the effort in June to include all infectious disease areas after identifying promising lead candidates.

Under the expanded deal, Translate stands to receive $425 million in upfront payment and Sanofi common stock, plus up to $1.9 billion in milestone payments, providing another endorsement of the potential for mRNA to generate vaccines.

Russia approves second shot

Sanofi is one of the signatories of a pledge by nine leading companies in the race to develop a COVID-19 vaccine that they will only apply for approval after phase 3 studies have been completed and their candidates have been thoroughly tested.

Russia however has forged ahead with its controversial approach to the pandemic by approving a second SARS-CoV-2 vaccine based on only preliminary human testing, just three months after clearing the Gamaleya Institute’s Sputnik V shot on similarly scant data.

The latest – called EpiVacCorona – was developed by the Vektor State Research Center of Virology and Biotechnology and has been cleared on the strength of clinical testing in just 100 subjects, according to local media reports.

Russian president Vladimir Putin announced the latest approval on state television. adding to concern that Russia has been rushing vaccines to approval in order to claim political capital.

Both the approved vaccines are now in phase 3 trials involving tens of thousands of patients, but results from those are not expected until mid-2021. Regardless, Russia has said it had accepted orders for 200 million doses of Sputnik V from Brazil, India and Mexico.

Russia is the world’s fourth-most affected country by the coronavirus pandemic with a total of 1.37 million cases and a little over 23,000 deaths.

Chinese inactivated vaccine safe

Also this week, A Chinese COVID-19 vaccine based on inactivated coronavirus has been shown to be safe and stimulate an antibody response in a preliminary 640-patient phase 1/2 trial has been published in The Lancet Infectious Disease journal.

Developed by the Beijing Institute of Biological Products, the BBIBP-CorV vaccine was given as a two-dose regimen and was found the be safe across a broad age range – from 18 to 80 – and stimulated a neutralising antibody response in all immunised subjects by day 42, the final day of follow-up.

Antibody levels were lower in older recipients, however. The authors said the results were encouraging, but it is not possible to say yet whether the vaccine will be protective against SARS-CoV-2 infection.

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EU ramps up supply of COVID-19 vaccine, drugs

The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate.

The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and comes as wealthy nations are scrambling to secure access to the initial supplies of the shots furthest ahead in development.

If the vaccines are approved and the contracts are fulfilled, they would supply more than two shots apiece for each of the EU’s 446 million inhabitants.

In the US, Health and Human Services Secretary Alex Azar suggested this week that the country will have enough doses of vaccine available for every America citizen by March or April next year, with production underway for six shots backed by the US government across more than 23 manufacturing facilities.

The latest agreement involves an undisclosed down payment to J&J, whose vaccine started phase 3 trials in September. It covers an initial order for 200 million doses for EU member states, followed by an option on a second 200 million tranche.

The bloc ordered 400 million doses of AZ and the University of Oxford’s AZ1222 vaccine in August, and followed that up with a contract for 300 million doses of the Sanofi/GSK shot last month.

Just this week, it emerged that AZ has the right to declare an end to the pandemic in July 2021, having previously said it would supply AZD1222 at cost while the outbreak is still ongoing, according to a Financial Times report.

Remdesivir procurement

Meanwhile, the EC has also reached an agreement with Gilead Sciences to secure “rapid and equitable” access to its antiviral drug Veklury (remdesivir) – just as there are reports of shortages emerging around the world.

The joint procurement agreement (JPA) covers the 27 EU member states as well as the UK and European Economic Area (EEA) countries over a six-month period from later this month, and will do away with the need for country-by-country reimbursement negotiations, according to Gilead.

Veklury was granted conditional approval in the EU for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen in July, but by that time a large proportion of the drug’s supply had already been snapped up by the US government.

Gilead said in a statement that a “greatly expanded supply of Veklury is expected to meet European real-time demand and stockpiling needs in October.”

The company says it is on track to produce more than two million treatment courses of Veklury this year, and several million more treatment courses in 2021 if required. It’s ramped up production capacity internally and through a series of agreements with contract manufacturing partners.

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FDA gives COVID-19 vaccine ‘advice’ after White House blocks guidance

The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach public.

The regulator published “advice” to vaccine developers as part of documentation prepared for a vaccine advisory panel scheduled to convene later this month.

The five-page document sets out the information the FDA wants to see on safety and effectiveness and chemistry manufacturing and controls (CMC), and represents a tightening of the criteria for an emergency-use authorisation (EUA).

For example, the agency wants to see median follow-up duration of at least two months after completion of the full vaccination regimen in phase 3 studies – which would make it almost impossible for a shot to get the green light before the US election given that the front-runner jabs require two doses given at least 3-4 weeks apart.

The Trump Administration blocked the FDA from introducing new guidelines because they would set back the timeline for a COVID-19 green light by several weeks, scuppering the President’s plans to get a shot available before Americans go to the polls on 3 November.

Trump has also accused the FDA of succumbing to political pressure to delay approval of a vaccine, which the agency denies, and says industry had objected to the tougher standards. That prompted this response from former FDA Commissioner Scott Gottlieb:

Consumer group Public Citizen meanwhile said today that the suppression of the FDA guidelines “represents the latest but most dangerous politicisation of the US public health response to the catastrophic pandemic.”

There has been speculation for some weeks that the Trump administration could try to authorise a vaccine without oversight from the FDA, and the agency’s decision to set out its criteria publicly suggests it is resisting any such move.

Trump has previously said that a vaccine may be available this month, and the administration has pledged to provide tens of millions of doses before the end of the year.

Michael Carome, director of Public Citizen’s Health Research Group, said that the interference from the White House is an “appalling action that will only feed public distrust in any future COVID-19 vaccine marketed under an EUA, fostering vaccine hesitancy and prolonging the pandemic.”

Industry is also concerned. Just last week, the BIO trade organisation sent an open letter to Health & Human Services Secretary Alex Azar asking that all new guidance developed by the FDA concerning EUA for vaccines to prevent the spread of COVID-19 be released.

“The…guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorised or approved,” said the letter, signed by BIO chief executive Michelle McMurry-Heath.

The current FDA Commissioner Stephen Hahn has previously insisted that the agency will not be swayed by political pressure during presidential election campaigning.

The FDA guidelines reportedly also envisage that an independent advisory committee should be convened to go over the data before it can consider EUA. With the election now less than a month away, the timeline for setting up and running an advisory committee would also make it highly unlikely that a vaccine could be available before then.

Among the leading vaccines, Pfizer/BioNTech’s RNA-based candidate looks like it is the only one with a chance of seeking an EUA ahead of the election. Moderna has said it doesn’t expect results with its RNA shot until later that month, while AstraZeneca’s adenoviral-based vaccine is still on clinical hold in the US.

The latest twist in the coronavirus vaccine story comes during another politically fractious week in the coronavirus fight, with Trump now back at the White House after contracting COVID-19.

He immediately courted controversy by downplaying the seriousness of the virus, removing his face mask while posing for pictures despite still being infectious, and claiming that vaccines are “coming momentarily.”

Meanwhile, Facebook has deleted a post in which Trump had claimed COVID-19 was “less lethal” than the flu, placing it behind a warning about “spreading misleading and potentially harmful information.”

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Moderna’s COVID vaccine works in older people, according to new data

Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19.

An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.

These antibody levels were also higher than those typically seen in people recovering from the virus, the company said.

There were also no serious adverse events reported. Some patients reported fatigue, chills, headaches and pain at the injection site, though the majority of symptoms resolved within two days. 

Each participant received two 100 microgram doses of the vaccine 28 days apart – the same dose used in the vaccine’s ongoing phase 3 trials.

Moderna said the results show that the vaccine works as well in older adults as it does in people aged 18 to 55-years-old.

Death rates from COVID-19 are much higher in older people, but often people in these age groups show smaller immune responses from vaccines than younger adults.

The company’s shares rose about 6% on the news.

Health officials had previously expressed concerns that Moderna’s phase 1 study was small and that results may differ for other populations, including older people. This analysis may allay those concerns.

The company has also noted that 18% of the participants enrolled in its phase 3 study are Black, Latino, Native American or Alaska Native – groups that are often underrepresented in clinical studies but have been hard-hit by COVID-19.

Moderna has received funding from the US government to expand its late-stage trial. The US has also bought 100 million doses of the mRNA vaccine for more than $1.5 billion – a deal that sparked controversy when the consumer advocacy group Public Citizen said that taxpayers were “paying twice” for the jab.

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Chinese starts vaccinating key workers against COVID-19; report

China has already granted emergency use authorisation to multiple COVID-19 vaccines developed by domestic drugmakers and started dosing key workers, according to local media reports.

Zheng Zhongwei, head of China’s COVID-19 vaccine development task force, made the revelation on Chinese television, saying that the vaccines were being used in people at high-risk of contracting SARS-CoV-2, including front-line medical staff, according to the China Daily news service.

Around 20,000 people have been vaccinated since emergency use was approved in July, focusing on healthcare workers and border control staff, and the plan is to scale up the programme before the winter to include other groups like those working in the transport and food industry, he said.

The identity of the shots cleared for emergency use isn’t yet clear. Several Chinese companies have started clinical trials of coronavirus vaccine candidates, and three shots based on inactivated SARS-CoV-2 from Sinovac and Sinopharm are heading for phase 3 testing, according to the World Health Organisation’s latest update on vaccine progress.

Another adenovirus-based vaccine from CanSino Biologics is also in late-stage development and has been approved for use in military personnel, according to the South China Morning Post.

Meanwhile, candidates from Sinopharm’s China National Biotec Group (CNBG) subsidiary are also heading for phase 3 trials outside China – namely in Peru, Morocco, Bahrain, United Arab Emirates and most recently Argentina – after getting approvals to start testing by regulators.

Faced with dwindling numbers of COVID-19 cases in China, CNBG is starting up studies of its inactivated vaccines overseas where outbreaks of the virus are still in full swing. China has gone several days without a locally-transmitted case of the infection.

One has been developed in collaboration with the Wuhan Institute of Biological Products, while the other is partnered with the Beijing Institute of Biological Products. Both have cleared phase 1/2 trials which according to Sinopharm showed they were safe and generated “high-titre” antibody responses against SARS-CoV-2.

China has said that it will prioritise access for countries from Africa, Latin America and the Mekong region – Myanmar, Laos, Thailand, Cambodia and Vietnam – when the vaccine is ready to be rolled out overseas.

Professor Chris Whitty, the UK’s chief medical officer, said over the weekend that he believes it is unlikely that a coronavirus vaccine will be widely available before winter 2021.

Meanwhile, the Financial Times has reported that the Trump administration is considering fast-tracking emergency-use approval of the ChAdOx1 adenoviral vaccine developed by the University of Oxford and AstraZeneca for use in the US ahead of the upcoming presidential election, after being slammed for his handling of the crisis.

That has been denied by the Department of Health and Human Services, but the pandemic continues to be a focus for political wrangling ahead of the election.

On Saturday, Trump tweeted a bizarre accusation that the FDA was deliberately holding up the development of vaccines and drugs for COVID-19 for political reasons.

FDA Commissioner Steve Hahn didn’t choose to respond to that assertion, which came in the build-up to the emergency use authorisation of convalescent plasma as a treatment for COVID-19 yesterday.

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EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million.

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials.

Those deals cover 200 million doses of J&J’s Ad26.COV2.S – with an option on another 200 million – and 300 million doses of the Sanofi/GSK candidate. Meanwhile, the EC is also talking to Pfizer/BioNTech, Moderna and CureVac about access to their COVID-19 shots.

There are concerns that the scale of the deals – which comes after a series of similar big orders from the US and other national governments – could make accessing supplies more difficult for organisations such the WHO and GAVI, which are aiming to supply less affluent countries.

Reuters says that the Commission has “urged EU states to shun the WHO-led initiative because it sees it as too expensive and slow.”

The EU is now suggesting that it could use a portion of its vaccine orders to supply countries elsewhere in the world, which could be viewed as stepping on the toes of these non-governmental organisation (NGO) initiatives.

“We will continue to work tirelessly to bring more candidates into a broad EU vaccines portfolio,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, adding that a vaccine “remains the surest exit strategy to protect our citizens and the rest of the world from the coronavirus.”

The advance order will be financed using the EU’s Emergency Support Instrument, a €2 billion fund set aside to cover purchases of vaccines, drugs and other goods needed to fight the coronavirus epidemic.

The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.

Last month, interim results from a phase 1/2 trial of ChAdOx1  were published in The Lancet and showed the jab was tolerated and generated immune responses against the SARS-CoV-2 virus in all vaccinated participants.

It is based on an adenoviral vector formed on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.

AZ said that it has now signed supply deals for around 3 billion doses of the vaccine, with Russia, South Korea, Japan, China, Latin America and Brazil also placing orders.

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Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course.

That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power will be a big factor as supplies of COVID-19 vaccines become available – and also that countries with deep pockets will be at the front of the queue.

Nevertheless, consumer advocacy group Public Citizen has slammed the amount Moderna is charging the US for the mRNA-1273 vaccine, saying that as taxpayer money had funded 100% of the work done to bring it to market the US is “paying twice” for the shot.

“When the president bragged on the campaign trail about his deal-making prowess, this isn’t what people had in mind,” said the organisation.

“It is absurd that Trump and [Health and Human Services Secretary Alex Azar] are touting $30 per course as a good deal for the American people, in light of the consistent and ongoing support from the US government towards mRNA-1273 research, development and manufacturing.”

The $1.525 billion order includes $300 million in incentive payments for swift delivery, in other words if the vaccine is approved for marketing or gets an emergency-use green light on or before 31 January next year.

It takes the total amount allocated to the vaccine by the US government to $2.48 billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273.

The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Moderna has previously said 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 a 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.

Shares in Moderna spiked up around 5% on the announcement, but fell back just as quickly to end the day only fractionally up.

Analysts said the US deal could lead to others being signed quickly as other countries try to snap up available stocks, once again raising fears of “vaccine nationalism” that will leave lower-income countries at the back of the queue when it comes to access.

The US government previously signed deals – all for 100 million doses – of a vaccine from Pfizer/BioNTech at a cost of $39 per course, $21 per dose for a Sanofi/GlaxoSmithKline shot, and $10 per dose for a Johnson & Johnson candidate.

It also has deals in place to supply vaccines from Novavax and AstraZeneca/University of Oxford for 100 million doses at $16 and 300 million doses at $4, respectively.

“The Trump Administration is increasing the likelihood that the US will have at least one safe, effective vaccine by 2021,” said Azar in a statement.

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Certara adds to its COVID-19 toolkit with virtual trials module

Drugmakers have been working with data specialist Certara on a new tool that they hope could speed up the development of  vaccines for COVID-19.

The new “biosimulation” tool is designed to make it easier for vaccine candidates across multiple patient populations through the use of virtual patients and trials, providing insights before any real-life studies have to be carried out.

With dozens of COVID-19 vaccine candidates in the pipeline, determining which are best for various populations cannot be answered quickly enough using traditional vaccine development approaches, according to Certara.

“By creating virtual patients and virtual trials, this new vaccine platform will facilitate dosing strategies for a range of patient cohorts impacted by COVID-19, such as the elderly and children,” the company said.

The new module is part of Certara’s Quantitative Systems Pharmacology (QSP) platform, which has been developed in an attempt to reduce attrition in clinical trials, with around 80% of drugs that move into phase 2 failing due to safety or efficacy issues.

QSP is used to predict how drugs may work in patients, depending on human pathophysiology, in an attempt to reduce the risk of failure when actual clinical trials get underway.

“Our QSP program has reached a state of development that can be scaled and leveraged across many development programs and therapeutic areas,” commented Piet van der Graaf, who heads up the QSP programme at Certara.

“The models can be used extensively to answer ‘what-if’ scenarios with virtual patients throughout the drug development process,” he added.

To date, Certara has focused its platform in immunogenicity and immuno-oncology studies, but it says it plans to get its COVID-19 biosimulation module ready as quickly as possible.

Last month, the Princeton, New Jersey-based company also launched a COVID-19 clinical outcomes database to provide information on the results of around 500 COVID-19 clinical trials and observational studies from around the world that are due to read out in the coming months.

The database already includes results from several dozen trials of potential coronavirus therapies including chloroquine, hydroxychloroquine, remdesivir, lopinavir/ritonavir, and favipiravir.

The database builds on a COVID-19 pharmacology resource that was launched by Certara in April to provide pharmacology simulation tools and a forum for scientific exchange.

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UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine

The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline.

The order has come in even before the vaccine has started clinical development, with a phase 1/2 trial not due to get underway until September. Sanofi is providing the vaccine candidates itself while GSK is contributing the adjuvant used to boost immune responses to it.

The UK has already claimed 100 million doses of the ChAdOx1 vaccine in development at the University of Oxford and AstraZeneca, as well as 30 million doses of a candidate from BioNTech/Pfizer and 60 million doses of another shot created by Valneva.

There has been speculation that the government was gearing up to place an order for the Sanofi/GSK vaccine over the last few weeks, and it is the first official order to come in since the two companies started collaborating on the programme in April.

The value of the order has not been publicly disclosed but has previously been estimated at up to £500 million.

Orders for the vaccine candidates in development for COVID-19 are coming in thick and fast from western governments, leading to concerns of “vaccine nationalism”, with affluent countries buying up the first available stocks and leaving poorer nations at the back of the queue.

The US and the UK – both among the countries worst affected by the pandemic – have been particularly active in signing coronavirus vaccine access deals.

GSK and Sanofi maintain they are committed to making their vaccine available around the world, and plan to provide a significant portion of total worldwide available supply capacity in 2021/22 to ACT Accelerator, an organisation set up to secure access to COVID-19 tests, treatments and vaccines in lower-income countries.

“With today’s announcement, the government has now secured early access to four different types of immunisation and a total of 250 million doses, giving the UK the most likely chance of finding a safe and effective vaccine at the quickest speed,” said the Department of Business, Energy and Industrial Strategy in a statement.

Sanofi’s recombinant vaccine is based on the same baculovirus production technology used in its seasonal influenza shots.

The Oxford/AZ candidate uses a non-replicating adenoviral vector, while BioNTech/Pfizer’s candidate is based on messenger RNA and Valneva’s comprises an inactivated form of SARS-CoV-2, the virus that causes COVID-19.

Having different types of vaccines in line is important, according to Kate Bingham, chair of the UK government’s Vaccines Taskforce, because it’s not yet clear if any of them will be effective.

“Whilst this agreement is very good news, we mustn’t be complacent or over optimistic,” she cautioned.

“The fact remains we may never get a vaccine and if we do get one, we have to be prepared that it may not be a vaccine which prevents getting the virus, but rather one that reduces symptoms.”

GSK and Sanofi are planning a phase 3 trial of their candidate by the end of 2020, which if positive could lead to regulatory approvals in the first half of 2021. They are scaling up production with the aim of producing a billion doses a year.

At last count there were 25 coronavirus vaccines in clinical development, according to a World Health Organisation update published yesterday, plus 139 candidates in preclinical testing.

A new NHS service has been launched to enable people across the UK to seek information on COVID-19 vaccine trials, and has received 72,000 sign-ups, according to the government.

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US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine

The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial.

The deal – part of the Trump administration’s Operation Warp Speed that aims to deliver 300 million coronavirus vaccines in early 2021 – has ignited fears of “vaccine nationalism” – wealthy nations buying up potential COVID-19 vaccines and restricting available supplies to countries without the same spending power. 

Last month, for example, hackles were raised after the US acquired most of the global supply of Gilead’s COVID-19 drug remdesivir until September, and there are concerns that vaccines will follow a similar path.

Along with the initial order for 100 million doses of BNT162, the federal government has also agreed a facility to acquire another 500 million, and says it will make them available for free to US citizens.

It is the largest deal to be signed under Warp Speed, and comes after the UK placed an order for 30 million doses of BNT162 for delivery this year and next.

Pfizer and BioNTech said in May they expected to have capacity to make “millions” of doses of the shot in 2020, rising to “hundreds of millions” next year, so at face value the UK and US orders seem to cover most of the near-term supply.

BioNTech chief executive Ugur Sahin said however that the partners “are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon.”

The two partners say they also intend to start supply discussions with the COVAX programme – run by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – which has been set up to enable equitable access to coronavirus vaccines around the globe.

In the meantime, the US has also placed big orders for coronavirus vaccines developed by Oxford University/AstraZeneca and Novavax as part of agreements that also include clinical development funding, and has provided development funding to Johnson & Johnson and Moderna under Operation Warp Speed.

The BNT162 programme, which is based on BioNTech’s mRNA technology, is currently testing at least four different vaccine candidates in clinical trials. A large-scale trial of the front-runner shot in 30,000 is due to start this month and could form the basis of an emergency-use approval, perhaps as early as October.

Price ceiling?

The size of the deal puts a nominal price per vaccine dose of around $19.50, which Bloomberg notes will likely set a price ceiling on what other vaccine developers can charge for their candidates if approved. Pfizer and BioNTech are testing one- and two-dose regimens of BNT162.

It still allows profit to be made on the vaccines, and Bloomberg analyst  Sam Fazeli says that it could allow Pfizer to make a windfall of more than $15 billion, assuming the vaccine confers protection with one dose.

Earlier this week, pharma executives told a congressional hearing in the US that they could not commit to providing coronavirus vaccines at cost over the long-term, but would do so during the pandemic.

The US currently has more than 4 million confirmed cases of COVID-19, with more than 145,000 deaths

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Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst

JP Morgan has downgraded its valuation of Moderna, saying its $37 billion market cap is way too high even if its COVID-19 vaccine mRNA-1273 succeeds in clinical trials.

Moderna’s share price has rocketed 385% this year, driven by the development of mRNA-1273, but the analysts think there are too many unknowns surrounding the coronavirus pandemic and the prospects for a vaccine to justify its valuation.

They have downgraded the stock from overweight to neutral, stressing however that the move “is not a call on any sort of diminished expectations around the company or mRNA-1273.”

More important are questions such as how long the pandemic will last, what price vaccine makers will be able to charge, and how many effective vaccines will become available, says JP Morgan.

Just yesterday, there were positive preliminary trial results with two other coronavirus vaccines – from Oxford University/AstraZeneca and CanSino Biologics – and at last count there were 24 candidates in clinical development.

mRNA-1273 – one of five vaccines in the clinical pipeline based on RNA – is also one of the furthest ahead in development, having already started phase 3 testing.

Earlier this month, Moderna reported initial clinical results from a US National Institutes of Health (NIH) study showing that two doses of the shot was able to stimulate neutralising antibodies against SARS-CoV-2, the virus that causes COVID-19.

“We remain bullish on Moderna’s long-term outlook, disruptive platform (in the vaccine space and otherwise), and chances of being one of the first companies to bring a COVID-19 vaccine to market,” write the JP Morgan analysts in a research note.

More positive data readouts could drive the company’s share price and market cap still higher, but “we’re simply unable to continue to fundamentally justify it,” they add.

They also think success with the COVID-19 candidate will read through to the rest of Moderna’s pipeline, which includes other vaccine candidates as well as RNA-based drugs for cancer immunotherapy and other diseases.

At the moment JP Morgan ascribes a value of $25 billion for Moderna’s mRNA platform, which is substantially above any other companies it covers.

They place a value for mRNA-1273 of $16 per Moderna share – trading at more than $82 today – with a 60% chance of success for the programme and peak sales estimates of $4.2 billion to 6.4 billion, depending on the duration of the pandemic.

The top end of those estimates apply if SARS-CoV-2 becomes endemic or the pandemic lasts through 2025 with people requiring annual shots for protection.

The lower end of the model – which JP Morgan give a 10% probability to – is that the pandemic lasts through 2022.

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‘Promising’ data on Oxford/AZ, CanSino coronavirus vaccines

Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus.

The first phase 1/2 results with the ChAdOx1 vaccine – also known as AZD122 – were published today in medical journal The Lancet and bode well for the outcome of much larger phase 2 and 3 trials that are already underway in the UK, Brazil and South Africa, say the investigators, led by Prof Andrew Pollard of Oxford University.

The data reveal that ChAdOx1 generated antibodies that were able to neutralise the SARS-CoV-2 virus in more than 90% of subjects aged 18 to 55 after a single dose, and 100% after two doses.

All vaccinated patients also showed increases in white blood cells (T cells) that can fight the infection and are thought to be an important factor in limiting the severity of COVID-19-related illness.

There were minimal side effects such as headache and fever, which could be prevented with paracetamol, according to the researchers.

AstraZeneca’s share price ticked up by almost 2% following the announcement.

ChAdOx1 is based on an adenoviral vector based on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.

“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this,” commented Prof Pollard.

Meanwhile, The Lancet also carries a 500-patient, phase 2 study from researchers in China on another adenoviral vector-based vaccine developed by CanSino Biologics, which also generated antibody and T cell responses and appeared to be safe.

An editorial accompanying the studies by Naor Bar-Zeev and William Moss at Johns Hopkins Bloomberg School of Public Health in the US notes that the results of the two trials “are broadly similar and promising”.

They add however that “much remains unknown about these and other COVID-19 vaccines in development, including longevity of response and immunogenicity in older adults or other specific groups.”

At the moment the follow-up period in both studies is vanishingly short in the context of typical vaccine studies, but it’s nevertheless encouraging that in the Oxford study the data show sustained immune responses for up to 56 days.

Some scientists estimate that vaccine protection for just six months or more could be enough to have an impact in controlling the coronavirus pandemic.

Larger studies are needed to conform these early findings and answer other key questions, such as how the vaccines perform in older people, those with concomitant illnesses and other high-risk individuals, and children.

Meanwhile, there have also been calls for so-called “challenge studies”, which would involve deliberately infecting subjects with SARS-CoV-2 after a vaccine to test directly the level of protection it confers.

Oxford University has partnered with AZ to produce the ChAdOx1 vaccine, and the UK government has already placed an order for 100m doses, with other big orders also received from the US, German, France and others.

The UK government has also just ordered 90 million doses of two other COVID-19 vaccines – from BioNTech/Pfizer and Valneva – plus an option for another 40 million doses.

Pfizer and BioNTech also announced further clinical data from the most advanced from a group of four vaccines they are developing, with data collected in Germany supporting findings of a US trial arm published earlier this month.

According to the latest estimates from the World Health Organization there are 23 potential vaccines in clinical trials and 140 in preclinical development.

 

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GSK-partnered Medicago starts trials of plant-based COVID-19 vaccine

Medicago has started dosing healthy volunteers in the first human trial of its candidate vaccine for COVID-19, a few days after partnering with GlaxoSmithKline on the project.

The Quebec, Canada-based biotech is using a different approach with its vaccine than the other candidates in clinical testing – 22 at last count according to the World Health Organisation – as its vaccine is based on recombinant coronavirus virus-like particles (CoVLP) made in plant cells.

GSK is contributing its vaccine adjuvant technology to the programme, which is designed to boost the immune response to the vaccine and potentially also allow it to be given in smaller doses, stretching supplies further.

Medicago is also testing its vaccine using another adjuvant supplied by Dynavax, to see which works best.

The CoVLPs mimic the structure of SARS-CoV-2, the virus that causes COVID-19, stimulating an immune response that theoretically should also protect against the coronavirus itself.

The biotech says its plant platform allows it to quickly develop very close copies of circulating virus strains – in a matter of weeks – and can be quickly scaled up to produce millions of doses.

It is already being developed for a seasonal influenza vaccine currently under regulatory review in Canada, and for a pandemic H1N1 flu shot ordered by the US government as part of its pandemic preparedness programme.

Preclinical experiments have suggested that the CoVLP shot can stimulate a high level of neutralising antibodies with a single dose, and Medicago is eyeing an aggressive timeline for its clinical development.

The phase 1 trial will enrol 180 healthy volunteers aged 18 to 55 and test three doses of CoVLP (3.75, 7.5 and 15 mcg) either alone or in combination with the adjuvants. If all goes well, it wants to start phase 2/3 testing in October.

The company’s production plans are to have 100 million doses of the shot ready for the end of 2021, with capacity for a billion doses a year once it finished construction of a new manufacturing facility in Quebec City, scheduled to come online in 2023.

Of the 23 coronavirus vaccines now in clinical development, five are based on inactivated SARS-CoV-2, five are based on recombinant copies of proteins found in the virus, and another five are based on RNA coding for viral proteins. There are four based on DNA plasmids, and three based on adenovirus expression systems.

“Creating a sufficient supply of COVID-19 vaccines within the next year is a challenge which will require multiple approaches, with different technologies,” said Bruce Clark, Medicago’s CEO.

“Our proven plant-based technology is capable of contributing to the collective solution to this public health emergency,” he added.

One of the lead vaccine candidates – Moderna’s RNA-based mRNA-1273 – produced anti–SARS-CoV-2 immune responses in all participants at the interim stage of an ongoing phase 1 study, according to a report published in the New England Journal of Medicine.

A phase 3 trial of the vaccine regimen – consisting of two 100 mcg shots given 28 days apart – is due to start on 27 July, said the US biotech.

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The Most Promising COVID-19 Vaccine Candidates In The Pipeline To Watch Out For

Coronavirus pandemic has infected over 10 million people worldwide with over half a million casualties. The lock-down and other restriction measures such as social distancing have somehow slowed down the virus spread initially. But these steps have caused many serious humanitarian and economic consequences. Countries worldwide are now easing the restrictions to bring their economies back on track by allowing the essential services and activities.

Since the release of the genetic sequence of the coronavirus in the second week of January, every day new insights and details about the nature of the virus are being published. Recently, over 239 scientists from 32 different countries have supported the airborne transmission of SARS-CoV2. Now, the WHO has also acknowledged the evidence of airborne spread of SARS-CoV2. With ease in restriction, the coming days are going to be more difficult. While on the other hand the pharmaceutical and biotech companies are working round the clock to develop the effective vaccine for Covid-19. As of today, more than 150 candidate vaccines are in the preclinical and clinical evaluations phases.

Here is a compiled list of five leading companies actively working to develop Covid-19 vaccines that might prove to be efficient and potential in preventing further spread of the COVID-19 infection: 

Moderna (mRNA-1273)

Moderan is one of the drug developers picked by the US government under its Operation Warp Speed (a public–private partnership, to facilitate and accelerate the development COVID-19 vaccines). In May, Moderna Inc. announced the positive interim Phase 1 result for its mRNA Vaccine (mRNA-1273) against coronavirus (SARS-CoV-2). Moderna’s vaccine basically uses messenger RNA to produce viral proteins. The company is about to start the phase III trial of the vaccine with over 30,000 volunteers.

AstraZeneca/Oxford (ChAdOx1 nCoV-19 /AZD1222)

ChAdOx1 nCoV-19 (AZD1222) is the leading vaccine against Covid-19, developed by Oxford University in partnership with pharma giant AstraZeneca. The vaccine is in the phase III trial in the UK,  the US, and Brazil. AstraZeneca has announced the agreement with Europe’s Inclusive Vaccines Alliance (IVA), to deliver around 400 million doses of COVID-19 vaccine starting by the end of 2020.

CanSino Biologics Inc (Ad5-nCoV)

Founded in 2009, CanSino Biologics Inc is working with Beijing Institute of Biotechnology to deliver Covid-19 vaccine. CanSino’s Ad5-nCoV is a recombinant adenovirus type-5 vector (Ad5) vaccine.. Ad5-nCoV is the first novel coronavirus vaccine in China which is in clinical trial. After the phase I result which was published in May, and the unpublished phase II trial that produced a safe and strong response, the China’s Central Military Commission has approved its use for one year as a “specially needed drug”. The Ad5-nCoV is right now at the phase III trial.

Inovio Pharmaceuticals (INO-4800)

Inovio Pharmaceuticals INO-4800 is a DNA based vaccine candidate against Coronavirus. Inovio is also a part of the US government’s Operation Warp Speed. The Inovio conducted phase I trial of INO-4800 in about 40 healthy adult volunteers, and published interim data on 30th June. The vaccine has the ability to generate balanced antibody and T cell immune responses in the body, which will be very helpful in the fight against coronavirus.The Inovio is expected to begin the phase II/III study of INO-4800 during this summer (in July-August).

Sinovac Life Sciences (CoronaVac)

Sinovac a china biopharmaceutical company working on CoronaVac, an inactivated COVID-19 vaccine candidate. Sinovac started the development of its inactivated vaccine against COVID-19 in Jan-2020, and in April it received approval from the National Medical Products Administration (“NMPA”) to conduct phase I and II clinical trials in China. On June 13, 2020 it announced positive preliminary results of its vaccine CoronaVac’s phase I/II clinical trial with no severe adverse effects. To launch the phase III trial of its vaccine in Brazil (in July this year), Sinovac has signed a collaboration agreement with Butantan (one of the leading producers of immunobiological products and vaccines in Brazil). 

Apart from the above mentioned five companies, more than 150 pharmaceutical companies worldwide are also in the race to develop the effective and safe vaccine for Covid-19. The overall process of vaccine development requires rigorous research and testing process, the availability of Covid-19 vaccine in the market is likely to take one and half years. 

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Types of COVID-19 Vaccines Being Developed Globally

A vaccine to prevent coronavirus disease 2019 (COVID-19) is being vouched as the only and the best hope to end the pandemic that has claimed the lives of more than 330,000 people worldwide.

Pharmaceutical companies and researchers across the world are in a race to develop a safe and effective vaccination for COVID-19. Many such vaccines are currently under development, while there are a few notable ones that are undergoing clinical trials in humans.

One such vaccine is the mRNA-1273 by Moderna, a USA-based pharmaceutical company, The vaccines by Moderna is currently headed toward Phase II clinical trial after recording success in Phase I. Unlike conventional vaccines, this one is a genetically-modified mRNA vaccine, which is easier to produce and can be produced at a mass scale quickly.

types-of-covid19-vaccines-light

There are different types of vaccines that are currently in the making, as highlighted in the graphic.

However, a real, safe, and effective vaccine may still be months away from public use. Vaccine development typically takes years and even if all the processes, including regulatory approvals, are expedited, it may still take months for an effective COVID-19 vaccine to be available.

Most of the vaccines being developed against COVID-19 targets the Spike-shaped protein present on the surface of the coronavirus. It is through S protein that coronavirus can attach itself to the host cells in humans. A vaccine that targets this protein will render the virus useless as it will no longer be able to attach itself to human cells and cause COVID-19.

Source: Mayo Clinic

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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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