FDA panel recommends approval of Pfizer’s Covid vaccine for emergency use
December 11, 2020 @ 09:18 +03:00
A key Food and Drug Administration advisory panel voted 17 to 4 with one member abstaining on Thursday to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States.
If the FDA accepts the nonbinding recommendation from the Vaccines and Related Biological Products Advisory Committee — which is expected — it would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.4 million people and killed roughly 290,000 in the U.S. in less than a year.
The committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.
The FDA could grant emergency use authorization of Pfizer’s vaccine as early as Friday, James Hildreth, a member of the committee, told NBC’s “Weekend Today” on Saturday. An emergency use authorization, or EUA, generally allows a drug or vaccine to be administered to a limited population or setting, such as to hospitalized patients, as the agency continues to evaluate safety data.
It’s unclear whether the FDA will authorize Pfizer and BioNTech’s vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.
FDA panel recommends approval of Pfizer’s Covid vaccine for emergency use, CNBC, Dec 11