Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate was highly effective without raising any specific safety concerns.
The FDA observed through the data that Pfizer and BioNTech’s vaccine offered protection after the first dose, while two doses — required by Pfizer about three weeks apart — were “highly effective” in preventing confirmed COVID-19 infection at least seven days after the second dose.
“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote in a pre-meeting briefing document.
Pfizer and BioNTech submitted to the FDA for EUA on Nov. 20. Should the vaccine receive the regulatory authorization, high-risk populations in the U.S. could start receiving it by mid- to late-December. Vaccine distribution could start within hours of FDA authorization.
The companies expect to produce up to 50 million doses of the vaccine worldwide in 2020, with 1.3 billion doses produced by the end of 2021.
A Phase 3 clinical study of the Pfizer and BioNTech vaccine found a 95% efficacy rate, leading to regulatory clearance by the United Kingdom, which administered the first vaccines through its National Health Service earlier today.
Pfizer currently specifies that its vaccine candidate should be stored at a super-cold –70° C., so the earlier U.K. approval should give U.S. officials a chance to evaluate how well the company’s dry ice storage containers work as the British distribute the vaccine.