Novavax (Nasdaq:NVAX) has won unanimous backing from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its NVX-CoV2373 COVID-19 vaccine. Voting 21 to 0 with one abstention, the VRBPAC recommended that FDA grant emergency use authorization (EUA) to the vaccine for adults 18 and older. The Novavax would be the fourth vaccine to…
FDA signals careful approach in mulling COVID-19 vaccine authorization in young children
FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months…
FDA hits pause on COVID-19 vaccine for children under 5
FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years. The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.…
VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters
The U.S. appears to be on the verge of expanding the use of COVID-19 vaccine boosters after an advisory committee backed boosters for the Johnson & Johnson (NYSE:JNJ) and Moderna (NSDQ:MRNA) vaccines. On Oct. 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products.…
FDA advisory panel recommends boosters only for older and high-risk individuals
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…