FDA says Pfizer vaccine is safe and effective
The data it 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.
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.