完整标题：FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe
发稿单位：NPR
发稿时间：December 8, 20208:34 AM ET
撰 稿 者：不明
原文连结：https://t.ly/Mu6l
The Food and Drug Administration released a detailed analysis Tuesday morning
of the COVID-19 vaccine from Pfizer and its partner BioNTech ahead of a
Thursday meeting of a group of independent experts that will advise the
agency on whether to grant the vaccine an emergency use authorization.
The agency's analysis finds "no specific safety concerns identified that
would preclude issuance of an EUA." Serious reactions were rare. Side effects
are common, however, with a majority of study volunteers experiencing
reactions at the site of injection, headaches and fatigue.
The analysis also affirms the previously stated vaccine effectiveness of 95%,
assessed a week after two doses of vaccine. The vaccine doses are given 21
days apart.
The clinical data also suggest that the vaccine may be able to prevent
COVID-19 after the first dose — 82% effective — though the FDA analysis
says the available information doesn't allow for a firm conclusion on that
potential effect.
The vaccine authorization under consideration is "for active immunization for
the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of
age and older."
On Thursday, the Vaccines and Related Biological Products Advisory Committee,
an advisory group, will discuss the vaccine in an open public meeting.
The agency will ask the experts to assess whether the available scientific
evidence supports the proposed emergency use of the vaccine. Specifically,
the committee will be asked whether the known and potential benefits of the
vaccine outweigh its known and potential risks in people 16 and older.
The FDA will also ask the experts to weigh in on what additional studies
should be done by the companies to further elucidate the safety and
effectiveness of the vaccine after it is available under an EUA.