Pfizer, BioNTech to submit EUA request Pfizer and BioNTech will submit a request on November 20 to the U.S. Food and Drug Administration for emergency use authorization (EUA) of their messenger RNA vaccine candidate, BNT162b2, against infection with the SARS-CoV-2 virus.
Pfizer, BioNTech just days away from applying for EUA for COVID-19 vaccine Pfizer and BioNTech have passed another milestone in their effort to deliver a vaccine for the SARS-CoV-2 virus. The companies on November 18 reported that their BNT162b2 vaccine candidate has met safety milestones and that they plan to apply for an emergency use authorization (EUA) from the U.S. Food and Drug Administration for the product in the coming days. Discuss
What are the unresolved questions about SARS-CoV-2 T-cell responses? Researchers have shed light on the "known unknowns" of preexisting and acquired T-cell responses in relation to SARS-CoV-2 infection. In a perspective piece, published in Science Immunology on November 18, scientists from Karolinska Institutet in Sweden discuss the role and durability of T-cell responses in COVID-19. Discuss
FDA commissioner commits to COVID-19 EUA transparency The U.S. Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn reaffirmed the agency's commitment to transparency regarding the emergency use authorization (EUA) process, including decisions to issue, revise, or revoke them.
EU secures 225M doses of CureVac COVID-19 vaccine The European Commission approved a fifth contract with CureVac for the initial purchase of 225 million doses on behalf of all European Union (EU) member states, plus an option to request up to an additional 180 million doses.