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Hereโs a look at FDAโs COVID-19 vaccine review process
Read full article: Hereโs a look at FDAโs COVID-19 vaccine review processScientists with the U.S. Food and Drug Administration (FDA) are working to review two COVID-19 vaccines submitted by drug companies Pfizer and Moderna. Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER). โThe safety profile of a vaccine thatโs going to be deployed in millions of people has to be incredibly clean,โ said Dr. Peter Marks, who directs CBER. โWe, as an agency, are one of the last agencies in the world that we still actually get the primary data. We donโt get summary data.โCBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.