In a review of data from late-stage trials of Pfizer/BioNTech’s experimental COVID-19 vaccine, scientists at the Food and Drug Administration (FDA) found the vaccine had a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization.”
The review is part of Pfizer and BioNTech’s request for emergency use authorization (EUA) for its vaccine, which it filed on Nov. 20. On Dec. 10, the FDA’s vaccine review committee will vote on whether the vaccine will be the first authorized in the U.S. to start shipping. FDA commissioner Dr. Stephen Hahn will take the committee’s vote into consideration in ultimately making that decision. The vaccine is already approved for use in the UK, where it was administered for the first time earlier today.
An EUA would allow the companies to start distributing their vaccine in the U.S. even while studies on its safety and effectiveness continue. The EUA requires that Pfizer/Biotech conduct a two-month follow-up of a subset (38,000) of the more than 44,000 people who participated in Phase 3 trials; Pfizer/BioNTech plan to continue following the volunteers for two years and then file for standard approval of their vaccine once they have longer-term data.
The two companies filed a 92-page request to the FDA, which included data from a Phase 3 study that showed the vaccine was 95% effective in protecting people from COVID-19 disease, with most of the vaccinated people showing only mild side effects. FDA scientists reviewed the data and concluded that the study results satisfied the EUA requirements for a safe and effective vaccine.
That analysis will be one of the presentations the vaccine review committee will hear on Dec. 10; scientists from Pfizer/BioNTech will also break down the data from the Phase 3 study and answer questions from committee members. The public is also invited to listen to the discussions and provide comment.
Following the meeting, which will be virtual and is scheduled to run from 9 a.m. to 5:15 p.m. E.T., the FDA could decide at any time whether to authorize the vaccine. If it does receive the green light, Pfizer CEO Albert Bourla has said the company will be ready to start shipping doses within hours.