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FDA Issues EUA For Pfizer-BioNTech COVID-19 Vaccine
The FDA has announced the first EUA for the COVID 19 vaccine from Pfizer-BioNTech, allowing for distribution to millions across the country.
The US Food and Drug Administration (FDA) has issued the first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer-BioNTech, allowing for distribution across the country.
The totality of the available data show that the vaccine may be effective in preventing COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The EUA assures the public and medical community that the FDA has conducted a comprehensive evaluation of all available safety, effectiveness, and manufacturing quality data.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, MD.
“Today’s action 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,” Hahn continued.
“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.”
The vaccine contains a small piece of the SARS-CoV-2 virus’s messenger RNA (mRNA) that causes cells in the body to create the virus’s characteristic “spike” protein. When a person receives the vaccine, their body then produces copies of the spike protein, which does not cause disease, but brings the immune system to learn to react defensively against SARS-CoV-2.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research. “Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”
“The FDA’s review process included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee,” Marks continued. “Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
