Covid-19 Vaccine

US government buys 66m doses of Moderna’s Omicron booster

The Biden administration has confirmed its plans to start a booster vaccination campaign in the autumn, and placed a $1.74 billion order for 66 million doses of an updated version of Moderna’s Spikevax shot. The updated vaccine will specifically target the BA.4 and BA.5 subvariants of Omicron which are currently driving a new wave of …

US government buys 66m doses of Moderna’s Omicron booster Read More »

Pfizer takes COVID jab with ‘enhanced’ spike protein into phase 2

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and …

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CDC panel gives green light to Novavax COVID-19 vaccine

A Centers for Disease Control and Prevention (CDC) advisory committee on Tuesday unanimously voted to recommend the Novavax COVID-19 vaccine, giving a green light to a fourth shot to fight the virus.   The Novavax vaccine is not expected to play a major role in the U.S. vaccination campaign, given that it is intended for …

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EU watchdog formally reprimands Commission over Pfizer texts

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. Emily O’Reilly today upheld her earlier preliminary verdict of “maladministration” by the Commission, saying the judgment is a “wake up call …

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Fauci: Take new subvariant seriously, but don’t ‘let it disrupt our lives’

Anthony Fauci, the government’s top infectious disease expert, said Tuesday that a new omicron subvariant on the rise is something to take seriously but should not be a cause for panic.   The subvariant, known as BA.5, is now the majority of COVID-19 cases in the United States. It is even more highly transmissible than earlier variants of …

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BioNTech bites back after CureVac patent challenge

BioNTech has responded to a patent infringement lawsuit filed by fellow German biotech CureVac over its COVID-19 vaccine, saying it will “vigorously” defend itself. CureVac revealed yesterday that had filed suit in the Düsseldorf Regional Court, claiming that mRNA technology used in BioNTech’s Comirnaty vaccine – partnered with Pfizer – infringes its intellectual property. The …

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Pfizer claims new $3.2bn COVID jab deal with US government

Pfizer and BioNTech have signed a new $3.2 billion supply contract with the US government for COVID-19 vaccines, covering 105 million doses that may include Omicron-targeted shots. The contract covers 30 µg, 10 µg and 3 µg doses – covering adults, children and infants, respectively – and will include an updated Omicron version “subject to …

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US panel backs Omicron-targeting vaccines for booster campaigns

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). After hours of deliberation, the panellists voted by 19 to two in favour of using redesigned booster shots, rather than simply using the currently authorised vaccines …

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Moderna says COVID booster works against Omicron subvariants

Moderna has reported top-line data suggesting that its COVID-19 booster vaccine candidate stimulates a strong immune response against the Omicron subvariants BA.4 and BA.5, which have driven an uptick in infection numbers in recent weeks. The news came hard on the heels of Moderna’s announcement that it will build a research and manufacturing facility in …

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FDA advisors back COVID jabs for very young children

The FDA’s vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the ages of six months. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of both vaccines in this age group, in light of rising …

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Moderna says new bivalent COVID-19 vaccine tops Spikevax

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax, with a significantly higher response also seen against other variants of concern, one month after …

Moderna says new bivalent COVID-19 vaccine tops Spikevax Read More »

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more

Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and …

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more Read More »

COV-BOOST trial data show value of fourth dose

Administering a fourth dose of an mRNA COVID-19 vaccine provides a stronger level of protection than a third dose, particularly in the over-70s, according to the latest readout from the UK COV-BOOST trial. The trial showed that a second booster with the mRNA shots developed by Moderna and Pfizer/BioNTech given around seven months after the …

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Moderna unveils first clinical data on bivalent COVID variant booster

Moderna has reported preliminary clinical results with a bivalent version of its COVID-19 vaccine that combines its original version with another targeting the Beta variant, and seems to offer improved protection. The booster shot – called mRNA-1273.211 – offered better and longer-lasting protection compared to the original SpikeVax shot against all SARS-CoV-2 variants, including the …

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Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more

Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.

EU says not enough evidence to warrant fourth COVID jabs

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty  or Moderna’s SpikeVax – the preferred …

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CureVac and GSK try again with COVID-19 vaccine

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. The first participants have been dosed in a new, second generation version – dubbed CV2CoV – which …

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Moderna follows Pfizer in asking FDA for second COVID booster okay

Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech which filed their Comirnaty shot earlier this week. There’s one big difference though – Pfizer is seeking a green light for second booster dose of Comirnaty for people aged 60 …

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The (sort of, partial) Father mRNA Vaccines Who Now Spreads Vaccine Misinformation (Part 2)

By DAVID WARMFLASH, MD This is part 2 of David Warmlash’s takedown of Robert W. Malone’s appearance (transcript) on the Rogan podcast. Part 1 is here Menstruation and Fertility Much more than the line about reproductive damage in the Wisconsin News clip that we used to open the story, Malone used the Rogan interview to …

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The (sort of, partial) Father mRNA Vaccines Who Now Spreads Vaccine Misinformation (Part 1)

By DAVID WARMFLASH, MD Robert W. Malone, MD MS, is a physician-scientist who will live in infamy, thanks to the Joe Rogan Experience Podcast boosting his visibility this past December regarding his criticism of COVID-19 vaccines, particularly the mRNA vaccines (Moderna and Pfizer-BioNTech). Subsequently, Malone was banned from Twitter, which further boosted his celebrity status. …

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Alnylam sues Pfizer, Moderna over COVID-19 vaccines

Alnylam claims it is owed a slice of the massive revenues booked by Pfizer and Moderna for their mRNA-based COVID-19 vaccines, because they are both infringing patents its holds on a delivery technology. The US biotech has filed a pair of lawsuits in Delaware alleging infringement of US Patent No 11,246,933, which covers lipid nanoparticles …

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Pfizer makes case for fourth COVID jab dose to FDA

Earlier this week, Pfizer chief executive Albert Bourla said that a second booster of its COVID-19 vaccine will be necessary to keep the pandemic under control, and the company has now asked the FDA to back this use. The company and partner BioNTech have filed for emergency use authorisation of a fourth dose of Comirnaty …

Pfizer makes case for fourth COVID jab dose to FDA Read More »

COVID vaccines not linked to excess deaths, says CDC

There is no evidence that vaccination with either the Pfizer/BioNTech or Moderna’s mRNA-based COVID-19 vaccines led to the death of patients, says a study by researchers at the Centres for Disease Control and Prevention (CDC). The analysis of data from US adverse event monitoring systems comes from the first six months after vaccination with the …

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COVID jabs now offered to all children aged 5 to 11 across UK

England and Northern Ireland have followed Wales and Scotland in offering healthy children aged between five and 11 a low-dose COVID-19 vaccine, making vaccination an option for a younger age group across the UK. Health Secretary Sajid Javid says the rollout will be “non-urgent”, and parents would be able to decide whether or not the …

COVID jabs now offered to all children aged 5 to 11 across UK Read More »

AZ halts development of Beta variant COVID-19 vaccine

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. The new vaccine – codenamed AZD2816 – started phase 2/3 trials as a booster dose for people vaccinated …

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Novavax COVID jab ‘could save UK money on boosters’

The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future booster campaigns, according to the former chair of UK Vaccine Taskforce. Dr Clive Dix said that Nuvaxovid has excellent clinical data and – as a it has good stability at …

Novavax COVID jab ‘could save UK money on boosters’ Read More »

The Social Science of Covid

By MIKE MAGEE As we enter the third year of the Covid pandemic, with perhaps a partial end in sight, the weight of the debate shows signs of shifting away from genetically engineered therapies, and toward a social science search for historic context. Renowned historian, Charles E. Rosenberg, envisioned a similar transition for the AIDS …

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Digital innovation drives vaccine development

It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccine development. Pfizer’s Josh Raysman, Saad Saeed, and Shanaya Deboo discuss vaccine awareness, access, and innovation. Access to and awareness of vaccines …

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Daiichi makes play for share of Japan’s COVID booster market

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The Japanese group says it hopes to complete clinical development of the vaccine and bring it to market in Japan before …

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EC criticised in probe of COVID vaccine texts with Pfizer CEO

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. The messages were requested via a freedom if information request by journalist Alexander Fanta of netzpolitik.org, who was following …

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Moderna starts dosing patients with its Omicron COVID jab

Moderna has started human trials of an Omicron version of its COVID-19 vaccine SpikeVax, just in case a modified version will be needed to boost protection against the new variant later this year. The biotech has also reported new data suggesting that may well be the case, with a six-fold reduction in neutralising antibody levels …

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Pfizer starts dosing patients with its Omicron COVID shot

Pfizer and partner BioNTech have started their clinical trial of a new version of their COVID-19 vaccine that has been specifically designed to protect against the Omicron variant. The trial in 1,420 adult patients aged 18 to 55 will include dosing with the partners’ existing Comirnaty mRNA-based vaccine with the Omicron-based jab in a mix-and-match …

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The Covid Vaccine’s PR Crisis: Health Innovation vs the Take-Down Power of Disinformation

By JESSICA DaMASSA Misinformation and disinformation (intentionally wrong information) have plagued the storyline of the Covid19 vaccine since the early days of its development, creating a healthcare communications crisis that has not only stalled U.S. vaccination rates, but has also raised questions about how medical and scientific experts will ever again win trust across audiences …

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US Supreme Court blocks Biden’s broad vaccine mandate in 6-3 decision

The US Supreme Court handed down two decisions today relating to COVID-19 vaccine mandates, issuing a stay to prevent a broad mandate from the Occupational Health and Safety Administration, but allowing a more limited Centers for Medicare and Medicaid Services mandate relating to healthcare workers. The OSHA mandate, due to kick in this week, would …

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Third dose of AZ’s COVID jab boosts Omicron antibodies

Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as well as other variants of the virus, including Alpha, Beta, Delta, and Gamma. The increased immune response was seen in people who received AZ’s shot as their primary vaccination as …

Third dose of AZ’s COVID jab boosts Omicron antibodies Read More »

Pfizer, Moderna are prepping new vaccines for Omicron

With evidence growing that the current crop of COVID-19 vaccines are less protective against infection with Omicron, both Pfizer and Moderna have announced plans to develop new versions of their mRNA-based shots that are tailored to the new variant. Pfizer has said that a COVID-19 jab specifically targeting Omicron, as well as other existing variants, …

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Gritstone bio trumpets first data for ‘multivariant’ COVID jab

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2. …

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FDA clears Pfizer, BioNTech COVID booster for younger teens

The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses …

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CDC eyes safety of J&J COVID jab as EU backs booster

Johnson & Johnson’s also-ran COVID-19 vaccine has been cleared in the EU as a booster shot, although its role in the US could be impacted by new data on rare blood clots. A Centres for Disease and Control Prevention (CDC) advisory committee is scheduled to meet today to discuss the new results, according to a …

CDC eyes safety of J&J COVID jab as EU backs booster Read More »

Patients ‘29% less likely to be hospitalised with Omicron’

Data from a real-world study South Africa has indicated that the Omicron variant of COVID-19 is 29% less likely to cause hospitalisation among infected adults than other strains – although the researchers behind the work stress the findings are preliminary. The results – released by healthcare insurance group Discovery SA and the South African Medical …

Patients ‘29% less likely to be hospitalised with Omicron’ Read More »

Booster COVID jabs offered to all adults in England

The UK government has said it will step up its COVID-19 booster vaccination dramatically, with everyone in England aged over 18 offered a third dose before the end of the month. Westminster has promised additional support for the devolved administrations in Scotland, Wales and Northern Ireland to step up the booster campaign, and Scotland has …

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Omicron may evade Pfizer/BioNTech COVID jab, says study

Preliminary study results from South Africa have suggested that antibodies stimulated by Pfizer and BioNTech’s Comirnaty are less effective against the new COVID-19 variant Omicron. A study by the African Health Research Institute (AHRI) has found that the less of immune protection was “extensive but incomplete,” meaning that some level of immunity was retained against …

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Omicron set to dominate in UK within weeks, says expert

The Omicron variant could supersede other strains of COVID-19 within the next few weeks to become dominant in the UK, according to an infectious diseases expert. Professor Paul Hunter of the University of East Anglia told the BBC this morning that it is likely there is already more than 1,000 cases of Omicron (also known …

Omicron set to dominate in UK within weeks, says expert Read More »

UK government rubberstamps millions of extra COVID vaccines

The UK government has placed a 114 million-dose order with Pfizer/BioNTech and Moderna – sufficient to provide two doses to every person in Britain – in a bid to future-proof against COVID-19 variants.  Health and Social Care Secretary, Sajid Javid, announced the move as researchers race to uncover the effect of existing vaccines on the Omicron …

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UK accelerates COVID booster plans in response to Omicron

The UK looks set to extend its COVID-19 booster vaccination programme to all over-18s, as the number of cases of the new Omicron variant of SARS-CoV-2 has reached double figures. The gap between second doses and boosters is also being reduced from six to three months in an attempt to get as much protection in …

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Pharma pledges rapid response to Omicron COVID variant

With governments around the world announcing measures to curb the new B.1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said they are poised to develop new shots if needed. News of the new variant emerged last week, and has resulted in travel bans being imposed on various African countries by …

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Turkey’s home-grown COVID vaccine project nears fruition

Turkey could have its own COVID-19 vaccine Turkovac available for use by the end of the year, according to the country’s Health Minister Fahrettin Koca. An emergency use authorisation (EUA) application for the inactivated SARS-CoV-2 vaccine has been submitted to the Turkish Medicines and Medical Devices Agency (TITCK) on the back of preliminary data from …

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EU authorises first COVID-19 vaccine for 5 to 11 year olds

The European Medicines Agency (EMA) has approved Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children between the ages of five and 11, as EU countries struggle to cope with rising infection rates. The EU regulator said that the under-12s should get a lower dose of the vaccine – 10 mcg rather than 30 mcg – …

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New COVID variant ‘may sidestep vaccine protection’

A new variant of COVID-19 identified in Botswana with dozens of mutations is being watched closely, amid fears it could be resistant to the effect of currently-used vaccines. The B.1.1.529 variant has more mutations affecting the spike protein targeted by vaccines than any other strain identified to date, although it’s not yet clear if it …

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FDA, CDC COVID jab decisions ‘will simplify booster messaging’

Three hurdles to allowing booster COVID-19 vaccinations for all adults in the US fell in swift succession on Friday, clearing the way for wider use of the Pfizer/BioNTech and Moderna shots. The FDA cleared emergency use of the two vaccines on Friday, which was swiftly followed by a recommendation from a Centres for Disease Control …

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AstraZeneca will make ‘modest’ profit from COVID vaccine

AstraZeneca has said it plans to start making a small profit from sales of its COVID-19 vaccine Vaxzevria, which brought in just over $1 billion in sales in the third quarter, after selling it at cost since it was first made available. The shift will come in the fourth quarter of the year as part …

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J&J deal with COVAX grants humanitarian access to COVID shot

Johnson & Johnson has reached an agreement to make its one-dose COVID-19 vaccine available to an arm of the COVAX facility that is focusing on providing shots to around 167 million displaced people around the world. World Health Organization-backed COVAX is already working hard to deliver vaccines to lower-income countries, but earlier this year set …

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Valneva gets EU deal for COVID jab, and may sue UK

Shares in France’s Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two years, including 27 million next year. The deal for the adjuvanted, inactivated SARS-CoV-2 vaccine still depends on authorisation of the jab by the European Medicines Agency (EMA) which is due …

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Moderna squares off with US government over COVID jab patent

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony. That is according to a New York Times report, which says Moderna is now in dispute with the National Institutes of Health (NIH) after it filed a US …

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Germany says only Pfizer COVID jab should be used in under 30s

Germany’s vaccination advisory committee has recommended that people aged under 30 should only be offered Pfizer/BioNTech’s COVID-19 vaccine Comirnaty, saying it seems less likely to cause heart inflammation than Moderna’s rival shot Spikevax. The draft guidance from the Robert Koch Institute’s STIKO committee also says that pregnant women, regardless of their age, should get the …

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One dose of Regeneron’s COVID antibody protects for eight months

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The results suggest that the REGEN-COV (casirivimab/imdevimab) antibody could play a key role in protecting people who do not mount a sufficiently strong immune …

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US court halts Biden’s COVID shots plan for companies

The US Federal Court of Appeals has issued a temporary stay on President Joe Biden’s plan for mandatory COVID-19 vaccinations for employees of businesses. The mandate says that workers in privately-owned businesses with over 100 employees would have the be fully vaccinated by 4 January, or be required to take weekly COVID-19 tests and wear …

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US backs COVID jabs for young kids – should others follow?

The US is now pressing ahead with plans to extend its COVID-19 vaccination campaign to younger children aged five and over, prompting a debate about the policy in other countries. It follows the decision by Centers of Disease Control and Prevention (CDC) Director Rochelle Walensky to back a widening of vaccination shot from the current …

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Pfizer’s COVID jab sales swell again, with $36bn forecast for 2021

Rocketing sales of COVID-19 vaccine Comirnaty have allowed Pfizer to raise its full-year forecasts for the shot once again to a whopping $36 billion, more than double its predictions just a few months ago. Fuelled by extensions to vaccination programmes to include children and booster shots, the BioNTech-partnered jab made nearly $13 billion in the …

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COVID jabs much more effective than virus at preventing infection

A US study has found that the immunity afforded by COVID-19 vaccines is much stronger than that stimulated by infection with SARS-CoV-2 in unvaccinated individuals. The report by the Centre for Disease Control and Prevention (CDC), based on an analysis of dozens of research studies and its own data, suggests that both vaccination and infection …

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Novavax gets first authorisation for its COVID-19 jab

Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other countries to follow suit in the coming weeks. The vaccine is the first based on recombinant protein to be approved anywhere in the world, and has the key advantage over …

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FDA delays review of Moderna COVD jab in adolescents

The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation in people receiving the shot. The decision leaves Moderna playing catch-up with Pfizer and BioNTech, whose Comirnaty vaccine was approved for …

FDA delays review of Moderna COVD jab in adolescents Read More »

CDC director backs COVID-19 jab for 5 to 11s, plus a fourth shot

The US looks set to see a big expansion of the country’s COVID-19 vaccination drive, with shots looking likely for children aged five to 11 as well as a fourth dose for adults who are immunocompromised. FDA advisors gave a green light to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children in that younger age …

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Pfizer and BioNTech’s COVID-19 Vaccine Receive the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots: The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 to <12yrs. with COVID-19 The committee reviewed the P-II/III trial for the COVID-19 vaccine which showed a 90.7% vaccine efficacy in patients without prior SARS-CoV-2 infection @7 Days after 2nd …

Pfizer and BioNTech’s COVID-19 Vaccine Receive the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 Read More »

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19

Shots: The P-II/III KidCOVE study evaluated the safety, tolerability, reactogenicity & effectivity of mRNA-1273 in 4753 children aged 6-12yrs. with COVID-19, administered as 28 days apart The study met its primary immunogenicity EPs & interim analysis showed a robust neutralizing Ab response after two 50 μg doses of mRNA-1273. The therapy was well tolerated with …

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19 Read More »

FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids

FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending …

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Pfizer and BioNTech Report Results of COVID-19 Vaccine Booster in P-III Trial for the Treatment of COVID-19

Shots: The P-III trial evaluates a booster dose of COVID-19 vaccine (30µg) in a ratio (1:1) in 10000+ individuals aged ≥16yrs. with COVID-19 who previously received the primary two-dose series of vaccine The results showed vaccine efficacy of 95.6% compared to a non-boosted group, median time b/w second & booster dose was ~11mos., symptomatic COVID-19 …

Pfizer and BioNTech Report Results of COVID-19 Vaccine Booster in P-III Trial for the Treatment of COVID-19 Read More »

FDA okays Moderna, J&J COVID jab boosters, plus ‘mix and match’

The FDA has authorised booster shots with Moderna and Johnson & Johnson’s COVID-19 vaccines, a month after giving the go-ahead to a third-dose of Pfizer/BioNTech’s shot. It has also authorised the use of different jabs as boosters than those people received for their primary vaccination – the so-called ‘mix and match’ strategy – on the …

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J&J mulls switch from non-profit status for COVID jab

Johnson & Johnson has been offering its COVID-19 vaccine for sale on a no-profit basis since it became available, but is thinking about a possible switch to a standard commercial model next year or in 2023. That was the position stated by J&J’s executive vice president Ashley McEvoy on the company’s third-quarter results call yesterday, …

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FDA panel backs booster shot for J&J COVID-19 vaccine

An FDA advisory committee voted unanimously in favour of a booster dose of Johnson & Johnson’s one-shot COVID-19 vaccine on Friday, as panellists suggested it should have been used as a two-dose regimen from the start. The verdict – which came the day after a third dose of Moderna’s two-shot vaccine was also backed by …

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FDA panel supports J&J Covid-19 vaccine booster; no vote on mixing and matching

Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.

Moderna unveils $500m plan for African vaccine facility

Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. The factory will be able to supply up to 500 million doses of mRNA shots a year, and cover the full spectrum of …

Moderna unveils $500m plan for African vaccine facility Read More »

J&J joins COVID-19 booster shot drive, filing with FDA

Johnson & Johnson’s COVID-19 vaccine has been a minor player in the US vaccination drive so far, but the company hopes it can have a bigger role as a booster shot. The drugmaker has filed for approval of a second dose of its one-shot Ad26.COV2.S vaccine for people aged 18 years and older, based on …

J&J joins COVID-19 booster shot drive, filing with FDA Read More »

EU backs broader use of Comirnaty as COVID booster than US

The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. The regulator’s human medicines committee (CHMP) said that a third …

EU backs broader use of Comirnaty as COVID booster than US Read More »

Novartis tightens up its COVID-19 vaccine policy for staff

Novartis has joined a growing number of companies insisting that its workforce is double vaccinated against COVID-19 if they want to work at one of its sites. The Swiss pharma group had earlier said it would require staff to either be vaccinated or have a negative COVID-19 test result within the last 14 days before …

Novartis tightens up its COVID-19 vaccine policy for staff Read More »

The Vaccine Brawl – A Legal Battle in Process

By MIKE MAGEE The power to mandate vaccines was litigated and resolved over a century ago. Justice John Marshall Harlin, a favorite of current Chief Justice Roberts, penned the 7 to 2 majority opinion in 1905’s Jacobson v. Massachusetts. Its impact was epic. In 1905, Massachusetts was one of 11 states that required compulsory vaccinations. …

The Vaccine Brawl – A Legal Battle in Process Read More »

Sanofi abandons mRNA COVID jab, despite positive trial

Sanofi has said that it won’t develop its mRNA-based vaccine for COVID-19 any further, even though it seemed to work in an early-stage trial, and will focus instead on another candidate partnered with GlaxoSmithKline. The French pharma group said it took the decision because mRNA vaccines from Pfizer/BioNTech and Moderna are already widely available today …

Sanofi abandons mRNA COVID jab, despite positive trial Read More »

CDC overrules its advisors, backing COVID booster for health workers

The Centre for Disease Control and Prevention (CDC) in the US has backed booster doses of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in line with its recent FDA approval, overruling the advice of its own expert advisors. The CDC’s Advisory Committee on Immunisation Practices (ACIP) voted unanimously yesterday to recommend a third dose of Comirnaty …

CDC overrules its advisors, backing COVID booster for health workers Read More »

Novavax files its COVID jab to WHO for emergency use listing

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology. Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the …

Novavax files its COVID jab to WHO for emergency use listing Read More »

FDA approves Pfizer COVID booster jabs for higher-risk groups

Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech’s COVID-19 vaccine, the FDA has followed through and cleared the shot. The FDA has amended the emergency use authorisation (EUA) for Comirnaty in line with its experts’ advice – for people aged over 65 and other adults at …

FDA approves Pfizer COVID booster jabs for higher-risk groups Read More »

Amnesty says COVID jab producers are causing human rights crisis

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their …

Amnesty says COVID jab producers are causing human rights crisis Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Documents published ahead of the panel by the FDA reviewers suggest that there is some evidence from observational studies that …

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips Read More »

EU ‘negotiating with Valneva’ over COVID-19 vaccine contract

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a …

EU ‘negotiating with Valneva’ over COVID-19 vaccine contract Read More »

UK poised to announce booster COVID jabs for over-50s

The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to its plan for third doses for people with weakened immune systems. The plan will see millions of doses of the Pfizer/BioNTech mRNA vaccine administered across the autumn and winter to …

UK poised to announce booster COVID jabs for over-50s Read More »

Valneva slumps as UK dumps €1.4bn order for COVID-19 jab

The UK has terminated its order for up to 190 million doses of a COVID-19 vaccine developed by French biotech company Valneva, accusing it of breaching their supply agreement. Valneva said it “strenuously denies” that allegation, but added that the €1.4 billion ($1.65 billion) contract does provide the UK government with the right to exit …

Valneva slumps as UK dumps €1.4bn order for COVID-19 jab Read More »

MHRA clears third doses of AZ, Pfizer COVID jabs

The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) …

MHRA clears third doses of AZ, Pfizer COVID jabs Read More »

AZ CEO Soriot urges caution on COVID booster doses

The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over the winter, according to AstraZeneca chief executive Pascal Soriot. In a letter to The Daily Telegraph newspaper with AZ’s head of biopharma R&D Mene Pangalos, Soriot write that the UK …

AZ CEO Soriot urges caution on COVID booster doses Read More »

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes …

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab Read More »

FDA schedules adcomm for Pfizer’s COVID booster filing

The FDA has said it will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over. The adcomm is scheduled for 17 September and will discuss the Pfizer/BioNTech filing as well as booster …

FDA schedules adcomm for Pfizer’s COVID booster filing Read More »

GSK takes SK bio-partnered COVID jab into phase 3

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. The move follows phase 1/2 results with SK bio’s GBP510, which …

GSK takes SK bio-partnered COVID jab into phase 3 Read More »

UK real-world study finds COVID-19 jab protection wanes

A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second …

UK real-world study finds COVID-19 jab protection wanes Read More »

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to …

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older Read More »

FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, …

FDA grants full approval to Pfizer/BioNTech COVID jab Read More »

COVID prompts another milestone, as India clears first DNA vaccine

The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. This is the first DNA vaccine to ever receive regulatory authorisation anywhere in the world, the first COVID-19 jab approved in India to treat children …

COVID prompts another milestone, as India clears first DNA vaccine Read More »

MHRA clears Moderna COVID vaccine for 12 to 17 year olds

The Moderna COVID-19 vaccine has become the second jab to be authorised for use in England, Scotland and Wales in children aged 12 to 17 after getting the nod from the Medicines and healthcare products Regulatory Agency (MHRA). It joins the Pfizer/BioNTech vaccine in being an option for that age group, having been approved in …

MHRA clears Moderna COVID vaccine for 12 to 17 year olds Read More »

Pfizer, BioNTech file for FDA approval of COVID booster shot

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and …

Pfizer, BioNTech file for FDA approval of COVID booster shot Read More »

FDA authorises COVID booster jabs for at-risk people

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or …

FDA authorises COVID booster jabs for at-risk people Read More »

UK cues up more Pfizer/BioNTech vaccines as price row looms

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 …

UK cues up more Pfizer/BioNTech vaccines as price row looms Read More »

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab

South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been …

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab Read More »

BioNTech says repeat doses may be better than modified COVID-19 jab

BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 …

BioNTech says repeat doses may be better than modified COVID-19 jab Read More »

Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter

Moderna made a massive $4.2 billion from sales of just under 200 million doses of its COVID-19 vaccine, taking its tally since approval to around $6 billion from 302 million shots. The tally makes the SpikeVax (mRNA-1273) vaccine the second biggest seller behind Pfizer/BioNTech’s Comirnaty, which pulled in $7.8 billion in the second quarter and …

Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter Read More »

UK extends COVID vaccination to 16 and 17-year-olds

The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in spread of the virus in younger age groups. The moves comes on the back of new advice from the Joint Committee on Vaccine and Immunisation (JCVI), which has concluded that …

UK extends COVID vaccination to 16 and 17-year-olds Read More »

Germany confirms booster COVID jabs will start in September

Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the delta variant of the coronavirus. Health Minster Jens Spahn said the decision was also taken because of concerns that the immune response stimulated by COVID-19 vaccines may start to diminish …

Germany confirms booster COVID jabs will start in September Read More »

AZ’s COVID-19 jab sales top $1.2bn, but come at a loss

AstraZeneca said this morning that it has made $1.2 billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. R&D expenses leaped 28% in the period, an increase that AZ said was “primarily” a result of its …

AZ’s COVID-19 jab sales top $1.2bn, but come at a loss Read More »

AZ says second COVID jab dose isn’t linked to rare clot reaction

A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the …

AZ says second COVID jab dose isn’t linked to rare clot reaction Read More »

First published data backs CanSino’s inhaled COVID vaccine

Early-stage clinical data with CanSino Biologics’ inhaled COVID-19 vaccine show that it was able to stimulate neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration. Published in The Lancet, a phase 1 study conducted in China showed that a two-dose regimen of aerosolised Ad5-nCoV was similar to that achieved with …

First published data backs CanSino’s inhaled COVID vaccine Read More »

Study finds jabs cut severe variant COVID disease after one shot

A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying from variants of concern dramatically, even after a single dose. AstraZeneca’s Vaxzevria was found to 87% effective after against the delta variant, which is now thought to be one of …

Study finds jabs cut severe variant COVID disease after one shot Read More »

EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK …

EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine Read More »

UK funds ‘long COVID’ research drive as restrictions ease

The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …

UK funds ‘long COVID’ research drive as restrictions ease Read More »

UK funds ‘long COVID’ research drive as restrictions ease

The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …

UK funds ‘long COVID’ research drive as restrictions ease Read More »

AZ, J&J tweaking COVID shots to reduce clotting risks; report

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help …

AZ, J&J tweaking COVID shots to reduce clotting risks; report Read More »

EMA finds possible link between mRNA COVID jabs and myocarditis

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation.  According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis …

EMA finds possible link between mRNA COVID jabs and myocarditis Read More »

Eyeing delta surge, Pfizer will file COVID-19 booster next month

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases.  The two companies have revealed data from an ongoing trial of …

Eyeing delta surge, Pfizer will file COVID-19 booster next month Read More »

Israel says Pfizer jab less effective against COVID-19 delta

The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread of the coronavirus after the emergence of the delta variant. The vaccine still seems to be able to prevent hospitalisation and severe cases of COVID-19, but its efficacy in preventing …

Israel says Pfizer jab less effective against COVID-19 delta Read More »

Unsure whether to get a COVID-19 jab? Just ask Vira!

With COVID-19 vaccine hesitance an increasing concern in the US, researchers at Johns Hopkins have developed a chatbot – called Vira – that aims to explode myths about vaccination. Worried that COVID-19 vaccines have serious side effects that are being covered up, or vaccines are being used to track the population? Or just uncertain whether …

Unsure whether to get a COVID-19 jab? Just ask Vira! Read More »

Ocugen preps filings for COVID-19 vaccine Covaxin on new data

Armed with new data from its development partner Bharat Biotech, Ocugen is planning to press ahead with plans to file for approval of their COVID-19 vaccine Covaxin in the US and Canada. Covaxin has already been approved for restricted emergency use in India, getting the green light in January months before the final results from …

Ocugen preps filings for COVID-19 vaccine Covaxin on new data Read More »

Zydus Cadila nears world-first human plasmid DNA vaccine approval

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans.  Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could …

Zydus Cadila nears world-first human plasmid DNA vaccine approval Read More »

UK body recommends COVID booster campaign in autumn

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive.  The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …

UK body recommends COVID booster campaign in autumn Read More »

UK body recommends COVID booster campaign in autumn

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive.  The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …

UK body recommends COVID booster campaign in autumn Read More »

EU and AZ both claim victory in COVID jab supply lawsuit

A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer than the amount sought by the European Commission. The EU had requested 120 million doses by the end of this month and 300 million by end-September, but the judge in …

EU and AZ both claim victory in COVID jab supply lawsuit Read More »

CureVac hit hard as its COVID jab fails to make the grade

CureVac has just had a harsh reminder of the perilous nature of drug development, after reporting that its mRNA-based COVID-19 vaccine was just 47% effective in its 40,000-subject phase 3 trial. That is below the threshold efficacy level for a vaccine laid out by the World Health Organisation (WHO) in the early stages of the …

CureVac hit hard as its COVID jab fails to make the grade Read More »

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients …

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial Read More »

Novavax’s COVID-19 Vaccine Demonstrates 90.4% Efficacy in P-III PREVENT-19 Study

Shots: The P-III PREVENT-19 study involves assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant vs PBO in 29,960 participants aged ≥18yrs. across 119 sites in the US and Mexico The study demonstrated 100% protection against mod. & sev. disease, 90.4% efficacy overall, and met the 1EPs. The study also showed 93% efficacy …

Novavax’s COVID-19 Vaccine Demonstrates 90.4% Efficacy in P-III PREVENT-19 Study Read More »

Novavax Covid-19 vaccine shows 90% efficacy, protection against variants

Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US?

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions …

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US? Read More »

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string …

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA Read More »

Ocugen gets a black eye as FDA denies emergency OK for COVID jab

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share …

Ocugen gets a black eye as FDA denies emergency OK for COVID jab Read More »

Kaiser Permanente, Centene, others join White House effort to boost vaccination rates

Several organizations, both providers and payers, have pledged to help the White House achieve its goal of administering at least one dose of the Covid-19 vaccine to 70% of Americans over the next month. These organizations are launching various initiatives to engage the unvaccinated, including call campaigns and financial incentives.

US orders 500m Pfizer/BioNTech COVID jabs for developing nations

The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX donation programme over the next two years. Pfizer and BioNTech are providing 200 million doses this year, and another 300 million in the first half of 2022, at a not-for-profit …

US orders 500m Pfizer/BioNTech COVID jabs for developing nations Read More »

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot …

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP Read More »

CMS ups Medicare payment for at-home vaccinations to about $75 per dose

CMS is increasing the payment for administering at-home Covid-19 vaccinations from around $40 to $75 per dose. The move comes amid the Biden administration’s push to boost vaccinations nationwide, including among older adults who may not be able to access vaccine sites.

Millions of COVID jabs risk being wasted, says UNICEF

Rich nations are being asked to start donating COVID-19 vaccines to other parts of the world straight away, to avoid a glut of surplus supply in the coming months that could see millions of doses going to waste. In an open letter, UNICEF and a host of A list celebrities argue that G7 countries will …

Millions of COVID jabs risk being wasted, says UNICEF Read More »

UK is talking to AstraZeneca about beta variant COVID jab

The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta …

UK is talking to AstraZeneca about beta variant COVID jab Read More »

Moderna ramps up EU COVID jab capacity via Lonza deal

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. The increased capacity depends on Moderna getting approval for a half dose of an updated version of the mRNA-1273 vaccine – targeting new …

Moderna ramps up EU COVID jab capacity via Lonza deal Read More »

100+ workers sue Houston Methodist over mandatory Covid-19 vaccination policy

The lawsuit alleges that the policy is akin to forcing employees to participate in a medical experiment as none of the vaccines available have received full FDA approval. But Houston Methodist rebutted these claims saying the vaccines are safe and effective, and requiring employees to get vaccinated is in the best interest of the patient.

Janssen COVID jab cleared in UK as fears of third wave mount

With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson’s Janssen division. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision …

Janssen COVID jab cleared in UK as fears of third wave mount Read More »

Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents

Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants with/out prior SARS-CoV-2 infection, robust Ab responses and was well tolerated The approval follows CHMP’s positive opinion to authorize the vaccine in this group. The extended indication for the CMA …

Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents Read More »

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3

GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response …

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3 Read More »

EU asks court to fine AstraZeneca over missing COVID jab shipments

Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious”  failure to meet the terms of its contract to supply COVID-19 vaccines to the EU. Rafael Jafferali Counsel for the Commission – Rafael Jafferali – insisted during the hearing at the Brussels Court of First …

EU asks court to fine AstraZeneca over missing COVID jab shipments Read More »

Belgium halts dosing of J&J COVID vaccine in under 41s after death

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition.  The unnamed woman – who was under the age of 40 – died on 21 May after being admitted …

Belgium halts dosing of J&J COVID vaccine in under 41s after death Read More »

Moderna will file COVID-19 jab for teens after trial shows 100% protection

Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next month. The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, …

Moderna will file COVID-19 jab for teens after trial shows 100% protection Read More »

Pfizer Initiates Study to Evaluate its Pneumococcal Vaccine with Booster dose of its COVID-19 Vaccine

Shots: The first enrolled patient has received their immunizations as part of a new study in adults ≥65yrs. evaluating the coadministration of 20vPnC with a booster dose of the Pfizer-BioNTech’s COVID-19 vaccine The trial will include ~600 adults who will be recruited from the P-III COVID-19 vaccine trial and will have received their second dose …

Pfizer Initiates Study to Evaluate its Pneumococcal Vaccine with Booster dose of its COVID-19 Vaccine Read More »

Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents

Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants aged 12-15yrs. which showed 100% efficacy and was well-tolerated. The submission of data in children aged 6mos.- 2yrs. are expected in Q4’21 The companies have submitted the data in adolescents …

Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents Read More »

10 Design Considerations for Vaccine Credentials

By ADRIAN GROPPER As COVID-19 vaccines become widely, if not fairly, available in different regions, both the public and private sector are working to develop vaccine credentials and associated surveillance systems. Information technology applied to vaccination can be effective, but it can also be oppressive, discriminatory, and counter-productive. But these systems can be tuned to reflect and …

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Survey: 42% of Americans may not go back to in-person care this year

Despite the ongoing Covid-19 vaccine rollout, a significant percentage of Americans say they are planning to delay care in 2021 or are unsure about in-person care, a new survey shows. Virtual visit options, insurance coverage and clear information on Covid-19 safety protocols are some of the factors that will drive provider selection this year.

Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM

Shots: The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence …

Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM Read More »

Cityblock nets another $192M, plans to expand into maternity and pediatrics

The startup, which provides primary care services to Medicaid patients, plans to use the funds to expand into new states and add maternity and pediatrics services lines. It also recently launched a vaccination site in conjunction with the New York Department of Health.

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12

Shots: The companies have started testing BNT162b2 in children aged 6-11yrs. with initial results anticipated in H2’21. The companies are planning to expand the vaccination to that age range by early 2022 The companies plan to initiate the safety of BNT162b2 (10/20/30µg) vs PBO in P-I/II trial in 144-participant Pfizer and BioNTech later plan to …

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Read More »

In rebuke of One Medical’s alleged vaccine antics, CA counties sever relationship

Several California counties and Washington state dropped One Medical as a partner in distributing vaccines after reports that it let people who weren’t eligible for the vaccine jump the line. A House panel is also launching an investigation into the company’s practices.  

Moderna’s “Secret Sauce”

By MIKE MAGEE This week J&J gained FDA approval for their 1-shot COVID vaccine, leading optimists like Pfizer Board member, Scott Gottlieb, to predict that we will have 100 million shots out there by the end of April, and on-demand offerings for the general public. In the race toward herd immunity, we could easily ignore …

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Beaumont shuts down Covid-19 vaccination scheduling for nearly 24 hours after breach

An unknown user publicly shared a link to access Beaumont’s Epic-enabled vaccination scheduling services, which resulted in 2,700 people making unauthorized appointments for a Covid-19 vaccine. The Michigan-based health system had to shut down its vaccination scheduling services and cancel the appointments.

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Shots: The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints Results: The level of protection against mod-to-severe COVID-19 infection was 72% in …

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine Read More »

The provider’s IT playbook for efficient, equitable Covid-19 vaccine distribution

The vaccine distribution process has begun and providers are figuring out how to make sure the doses are administered quickly, equitably and in a coordinated manner. Here is a snapshot of the IT strategies that providers are employing to achieve their vaccine administration goals.

COVID-19 Vaccine: What to Expect with the Vaccine and Everything Else about it?

Finally, the End is Near!!! I am not talking about THE end of the world but an end to our struggles with the deadly COVID-19 pandemic. Because, the COVID-19 Vaccine is on its way to us (And I mean literally, it is on the way as we are talking). According to an NDTV post on …

COVID-19 Vaccine: What to Expect with the Vaccine and Everything Else about it? Read More »

States threaten to crackdown on providers amid Covid-19 vaccine distribution

In an effort to ensure the efficient and orderly distribution of the Covid-19 vaccine, governors from New York, California and Florida are warning that they will take action against providers who are conducting vaccinations too slowly or healthcare workers who undercut priority guidelines.

Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.

CO2 Safety Monitors for Dry Ice Vaccination

Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release …

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The known unknowns of COVID-19 vaccines

News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain. “There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech …

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BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged …

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China Read More »

What, Us Worry

By KIM BELLARD 2020 has been an awful year.  Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic.  Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering, and over a quarter million of us didn’t survive to …

What, Us Worry Read More »

Can the Government Mandate a Covid-19 Vaccine? Will It Have To?

By PHILLIP MEYLAN With the emergence of two vaccines with high levels of effectiveness, there’s a strong prospect of having powerful new tools to combat Covid-19 in the months ahead. But the road between a vaccine and society returning to normal is far from certain. Millions of doses will need to be produced and intelligently distributed, and critically, …

Can the Government Mandate a Covid-19 Vaccine? Will It Have To? Read More »

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Shots: J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally J&J affirmed …

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development Read More »

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Shots: Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per …

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19 Read More »

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Shots: CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 M, including $69.5M previously announced have funded preclinical studies and P-l study, preparations for the global pivotal P-ll/lll efficacy study, and initial manufacturing scale-up activities The expanded collaboration will provide $258.5M for a global pivotal P-ll/lll efficacy clinical trial which is …

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate Read More »

Data hackathon analyses truth behind TB vaccine and COVID-19

Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence. Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial …

Data hackathon analyses truth behind TB vaccine and COVID-19 Read More »

COVID-19 biologics will put huge pressure on large-scale bioprocessing networks

Tightening of bio-manufacturing capacity expected to occur after 2024, whilst Europe forecast to equal North America in total capacity Amsterdam:  The third part of the 2020 CPhI Annual Report – released during the second week of the CPhI Festival of Pharma (5-16 October, 2020) – predicts, that if approved, COVID vaccines and therapeutics will cause an impending biomanufacturing capacity …

COVID-19 biologics will put huge pressure on large-scale bioprocessing networks Read More »

AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan

Shots: The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial A standard review process triggered a voluntary pause to vaccination across all global …

AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan Read More »

Governments have a public health duty to expand vaccination coverage through pharmacies, FIP says

The Hague — Governments and other stakeholders must take urgent action to ensure equity in access to disease prevention measures, which includes greater investment in vaccines and vaccination services by community pharmacists. So said the International Pharmaceutical Federation (FIP) in a call to action made today at the start of a new FIP Digital Programme to …

Governments have a public health duty to expand vaccination coverage through pharmacies, FIP says Read More »

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Shots: BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market On Mar 13, 2020, …

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao Read More »

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 …

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

Ingenza meets a key milestone in the deployment of novel cost-effective COVID-19 vaccine technology

Edinburgh-based biotech company Ingenza Ltd. has made a significant breakthrough in the race to develop and manufacture a cost-effective vaccine against SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. Ingenza has been working closely with researchers at Oxford University and the UK CPI, Wilton, since the start of the outbreak, and the collaboration is …

Ingenza meets a key milestone in the deployment of novel cost-effective COVID-19 vaccine technology Read More »

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements

Shots: For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being …

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements Read More »