The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains...
The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
A UK study, which has been trialing the combination of Oxford-AstraZeneca and Pfizer vaccine doses, is now extending the program to include Moderna and Novavax vaccines.
The US National Institutes of Health (NIH) has started a clinical trial to determine whether people who are highly allergic, or have a mast cell disorder, are at increased risk of allergic reactions to the Moderna and Pfizer COVID-19 vaccines.
Valneva will take its COVID-19 vaccine candidate into a Phase 3 clinical trial this month, following positive Phase 1/2 data for the inactivated, adjuvanted vaccine.
When BioNTech calls 2020 a transformational year, it’s something of an understatement: with the company partnering with Pfizer to bring the first mRNA COVID-19 vaccine to market. So what’s next? BioNTech pledges to accelerate and expand its innovation...
Pfizer and BioNTech’s COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in adolescents aged 12-15 years old, according to results from a Phase 3 trial released this week. “We plan to submit these data to the FDA as a proposed amendment...
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
As tensions over COVID-19 vaccine supplies in Europe continue, AstraZeneca clarifies that a set of doses at its Anagni plant in Italy are destined for the EU and COVAX.
AstraZeneca has released the primary analysis from its COVID-19 vaccine US Phase 3 trial, showing 76% efficacy for the vaccine against symptomatic COVID-19. The company highlights that this backs efficacy data from Monday's interim analysis, responding...
The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated information’ when releasing initial data from its COVID-19 vaccine clinical trial.
Preclinical data shows that CureVac’s COVID-19 vaccine protects against challenge infections with the B.1.351 ‘South Africa’ variant in a transgenic mouse model.
Australia’s Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL – Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin....
CureVac is expanding its late-stage clinical trials for its COVID-19 vaccine candidate; while confirming it is on schedule to apply for formal market authorization in the EU in Q2 2021.
A laboratory study published in the New England Journal of Medicine shows the Pfizer/BioNTech COVID-19 vaccine was able to neutralize the emerging Brazil coronavirus strain.
Baxter BioPharma Solutions will provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of Moderna’s COVID-19 vaccine this year.
A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical...
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the...
The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.
This week France has raised the age limit for the AstraZeneca COVID-19 vaccine; but Canada, conversely, has put a 65-year-old limit into its recommendations.
The Pfizer/BioNTech COVID-19 vaccine – which requires ultra-cold storage – will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...
Moderna has announced new capital investments to increase COVID-19 vaccine manufacturing capacity: targeting global capacity of 1.4 billion doses in 2022.
Moderna’s variant-specific vaccine – designed to tackle the South Africa variant – has been shipped to the US National Institutes of Health (NIH) for a Phase 1 clinical trial.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
Sanofi and GSK have initiated a new Phase 2 study for their COVID-19 vaccine candidate; with a Phase 3 study set to follow in Q2 and potential rollout of the vaccine in Q4.
Sanofi’s vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Janssen’s COVID-19 vaccine: producing around 12 million doses a month to help address global supply demands.
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions....
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following...
AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO): meaning the vaccine can be rolled out globally through COVAX.
CureVac has initiated a rolling review with the European Medicines Agency (EMA), working towards authorization for its mRNA COVID-19 vaccine in the European Union.
While some jurisdictions have limited the use of the Oxford University / AstraZeneca COVID-19 vaccine, the WHO says it can be used even where variants are known to be in circulation and with people aged 65+.
Three COVID-19 vaccine manufacturing sites are set to start production in France in the coming weeks: while the French government is seeking to boost further production with a €300m ($363m) initiative announced on Monday.
BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.
Johns Hopkins Medicine researchers have studied the reaction of nearly 200 solid organ transplant recipients to their first COVID-19 vaccine shot. The findings, they say, suggest that the Moderna and Pfizer/BioNTech mRNA vaccines can be safely given to...
CureVac aims to bring together expertise from both its own company and other stakeholders to provide ‘broader and faster protection against current and future viral threats’: through collaborations with the UK Government, Bayer and GSK.
