Topline
The Food and Drug Administration hopes to grant full approval to Pfizer and BioNTechs coronavirus vaccine next week, the New York Times and Politico reported, an earlier-than-expected step some health experts think would boost vaccination rates as Covid-19 cases climb nationwide.
A medical staff prepares a vial from the Pfizer/BioNTech vaccination against Covid-19 at an Erfurt, Germany, vaccination center on April 8. Getty Images
The Key Facts
According to the Times, unnamed sources reported that the FDA is trying to approve the vaccine, which currently has an emergency authorization, by Monday. However, this timeline could be delayed while staffers sort through paperwork. Politico reported that the FDA is expected to complete their approval process next week. Although the FDA has stated that they will expedite the process of vetting the vaccine, they have not yet set a timeline. However, the Times reported earlier in the month that the FDA had given itself a Labor Day deadline. Forbes was referred by Pfizer to the FDA to address all questions regarding vaccine approval. The FDA did not respond to a request to comment immediately.
Important Background
Pfizer and Modernas Covid-19 vaccines were granted FDA emergency use authorization late last year. Johnson & Johnsons single shot vaccine was added to the FDA roster earlier in the year. To get an emergency authorization, drugmakers must submit detailed safety data. This indicates that the benefits of a drug outweigh its potential risks. Full approval, however, is more time-consuming and requires more data and vetting. Public health experts are urging the FDA to approve the full application as soon as possible. They argue that this designation will increase Americans' confidence in vaccines and encourage others to get vaccinated. This could also lead to additional vaccine mandates. The Pentagon has stated that it will require all U.S. military personnel (roughly 1.4 million) to be vaccinated once a vaccine is fully approved. Some colleges have yet to receive full approval before implementing mandates for students. Other hospitals will also require staff to be vaccinated after FDA approval.
Big Number
60.4% According to data from Centers for Disease Control and Prevention, this is the percentage of Americans who have been at least partially vaccinated against Covid-19. Last week, an average of 438.270 people lined up to get their first vaccination shot each day. This is nearly twice the number who waited in July. However, the CDC still reports that vaccines have fallen well below their April peak when 2 million people received their first doses per day.
Continue reading
F.D.A. The F.D.A. intends to approve Pfizers Covid vaccine Monday (New York Times).
FDA approval for Pfizer Covid shot could be forthcoming next week (Politico).
Why hasn't the FDA fully approved any Covid-19 vaccines yet? (Forbes)
