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The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.
On Dec. 17, 2020, FDA posted answers to frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine that the agency granted Emergency Use Authorization (EUA) to on December 11. The FAQ webpage addresses the agency’s reasoning behind the EUA as well as information on the vaccine.
FDA also discusses whether or not the agency believes the Pfizer–BioNTech COVID-19 vaccine will meet the standards for a biologics license application (BLA). “If safety or effectiveness concerns arise with a vaccine under EUA, FDA has the authority to revoke the EUA. However, it is expected that the data supporting the EUA, together with those that will be collected during use of vaccine under EUA and additional data collected from ongoing trials, will be sufficient to support licensure (approval) of a vaccine authorized under EUA,” the agency answered.
The agency also clarified how it plans to gather additional data on the vaccine. “Additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical studies already underway before the EUA was issued, plus studies conducted by the manufacturer or by the US government evaluating effectiveness of the vaccine as used under the EUA,” FDA stated.