FDA issues emergency authorization for Pfizer COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) recently issued the first emergency use authorization (EUA) allowing the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S., according to a release by the FDA.

The decision to issue the EUA came after the FDA thoroughly evaluated the vaccine for safety, effectiveness and manufacturing quality, and received input from FDA career scientists and independent experts. The vaccine has been approved for use in individuals 16 years of age and older. 

“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, M.D. “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.”

An EUA is different than an FDA approval (licensure) of a vaccine. The FDA issued the EUA after doing an assessment of the potential risks and any known or potential benefits, and determined that the benefits of making the vaccine available during the current COVID-19 public health emergency outweighed the potential risks.

“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks."

The EUA for the Pfizer-BioNTech vacine will be effective until the FDA determines that circumstances justifying the authorization of the emergency use of unapproved drugs for prevention and treatment of COVID-19 is terminated or if the FDA determines that the vaccine no longer meets the statutory criteria for the EUA.