The U.S. Food & Drug Administration Approves the First COVID-19 Vaccine

The U.S. Food & Drug Administration Approves the First COVID-19 Vaccine

Extensive research and trials lead to the FDA’s final decision of approval.

A milestone is reached for the vaccine. Music to many ears, the Pfizer-BioNtech COVID-19 Vaccine is officially approved by the FDA as of August 23, 2021. It will now be marketed as the Comirnaty of the disease in individuals who are 16 years old and older. The shot continues to be available under emergency use authorization (EUA), including for individuals ages 12 through 15 years old. This also includes the administration of a third dose in specific immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

FDA-approved vaccines undergo the agency’s extensive and standard process to ensure safety and accuracy in addition to reviewing the effectiveness of the medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). Based on results from a clinical trial, the vaccine was 91 percent effective in preventing the disease. More than half of the clinical trial participants were monitored for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least six months for precautionary reasons.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

The FDA and CDC have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct post-marketing studies to further assess risks. For extensive information on the FDA approval of the Pfizer-BioNtech vaccine click here.

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