WASHINGTON — The U.S. Food and Drug Administration appears to back Pfizer’s bid for emergency use of its coronavirus vaccine, saying that the shot showed “a favorable safety profile, with no specific safety concerns” in briefing documents posted Tuesday morning.
Patients’ immune response to the vaccine kicks in quickly after the first dose with roughly 88 percent efficacy in the week afterwards, according to data supplied by Pfizer and its German partner BioNTech. The second of two doses bumps efficacy to more than 95 percent and gives what is expected to be longer lasting immunity.
The agency released its analysis of the vaccine on Tuesday ahead of a meeting of its independent vaccine advisory committee on Thursday. FDA could authorize the vaccine for emergency use at any time after the meeting, though it’s not bound by the committee’s recommendations.
President Donald Trump has called on the agency to move fast, with pressure building after the U.K. and other countries authorized emergency use of the shot for their populations.
Pfizer, the first company to file for emergency use of a coronavirus vaccine in the U.S., is seeking authorization to use the vaccine in people 16 and older.
The datait submitted to FDA suggests that people begin producing antibodies within 10 days, which could help vulnerable people get some level of protection as they await the second dose. The agency said the first dose reduces the risk of severe Covid-19, for example.
FDA’s vaccine advisory panel will discuss the briefing documents and hear from Pfizer executives on Thursday. The panel of doctors, vaccine experts and statisticians will vote on whether to recommend the shot for emergency use.
The briefing documents also note that there was a severe case of Covid-19 infection in the vaccine arm of the trial and three in the placebo arm.Six people died during the trial — four in the placebo group, and two in the vaccine group — but none of those deaths has been linked to the vaccine.
Pfizer’s Kathrin Jansen, head of vaccine research and development, and William Gruber, senior vice president for vaccine research, are expected to discuss the severe case and any safety concerns in the Thursday meeting.
Source: POLITICO https://www.politico.com/news/2020/12/08/fda-pfizer-coronavirus-vaccine-safe-443587?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication