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Pfizer-BioNTech Vaccine Receives Emergency Use Authorization

MONDAY, Dec. 14, 2020 -- The Pfizer-BioNTech COVID-19 vaccine has received the first emergency use authorization (EUA) for a COVID-19 vaccine in the United States.

The U.S. Food and Drug Administration issued the EUA for use of the vaccine in individuals ages 16 years and older late Friday evening, allowing a national vaccine campaign against the virus to begin this week. U.S. Centers for Disease Control and Prevention Director Robert R. Redfield, M.D., signed the recommendation by the Advisory Committee on Immunization Practices on Saturday night. "Initial COVID-19 vaccination is set to start as early as Monday," Redfield said in a statement to the media on Sunday, "and this is the next step in our efforts to protect Americans, reduce the impact of the COVID-19 pandemic, and help restore some normalcy to our lives and our country."

The FDA said it determined the data provide "clear evidence that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19" and demonstrate that the potential benefits of the vaccine outweigh the potential risks. The vaccine is administered in two doses three weeks apart. Recently published CDC guidelines recommend that health care workers and nursing home residents and staff should be the first to receive the vaccine.

The EUA was based on data from an ongoing randomized, placebo-controlled international study of 37,586 individuals: 18,801 received the vaccine and 18,785 received saline placebo. Patients were followed for two months after the second dose. Commonly reported side effects -- reported more often after the second dose -- included injection site pain, tiredness, headache, muscle pain, chills, joint pain, and fever. Efficacy data were based on an analysis of 36,523 participants in the study who did not have evidence of severe acute respiratory syndrome coronavirus 2 seven days after the second dose; 18,198 received the vaccine and 18,325 received placebo. Researchers found the vaccine was 95 percent effective in preventing COVID-19. There were eight cases of COVID-19 in the vaccine group and 162 in the group receiving placebo; one and three cases in the COVID-19 and placebo groups, respectively, were classified as severe.

In an agency news release, FDA Commissioner Stephen M. Hahn, M.D., said the EUA "follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

Pfizer and vaccination providers are required to report all vaccine administration errors, serious adverse events, any cases of multisystem inflammatory syndrome, and COVID-19 cases resulting in hospitalization or death. The company has submitted a pharmacovigilance plan to complete longer-term safety follow-up for patients enrolled in the ongoing trials as well as other activities to monitor the safety profile of the vaccine and ensure any safety concerns are evaluated.

The EUA was issued to Pfizer.

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Posted: December 2020

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