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.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
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.
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
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 EU has entered into negotiations with Pfizer/BioNTech for a third COVID-19 vaccine contract: which would see delivery of 1.8 billion doses of the vaccine between 2021-2023.
REGEN-COV (casirivimab with imdevimab) has been shown to reduce the risk of symptomatic SARS-CoV-2 infections by 81%, in a Phase 3 study among household contacts of infected individuals.
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnson’s COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZeneca’s COVID-19 shot.
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
The European Medicines Agency’s safety committee, PRAC, has concluded there is a possible link between the use of AstraZeneca’s COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
Media reports claim the UK regulator is set to ban the use of COVID-19 Vaccine AstraZeneca in individuals below the age of 30 over blood clot risk concerns.
