Biotech Values

[DewDiligence]

FDA authorizes PFE/BNTX booster for_age_65+_and_high-risk individuals:

https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

• individuals 65 years of age and older;

• individuals 18 through 64 years of age at high risk of severe COVID-19; and

• individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Today’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.

“…the FDA amended the EUA…to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, M.D.

The FDA is still reviewing the EUA submission for Moderna’s booster shot, where the only remaining issue is the dose. MRNA thinks a dose half as much as the dose used for the first two shots would suffice for the booster, but the FDA may want to go with the full dose. An advisory committee will hash this out.