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ACP Supports ACIP Recommendation of Full FDA Approval for Pfizer-BioNTech COVID-19 Vaccine

PHILADELPHIA, September 1, 2021 – The American College of Physicians (ACP) supports the recommendation of the Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) for use of the  FDA-approved Pfizer-BioNTech COVID-19 vaccine  in persons 16 and older in the U.S. ACIP voted unanimously on August 30, 2021 to recommend use of the Pfizer-BioNTech COVID-19 vaccine for people 16 years of age and older under the FDA's Biologics License Application (BLA) approval.

The Pfizer-BioNTech COVID-19 vaccine had been authorized by the FDA for emergency use in the U.S. since mid-December 2021 for people who are age 16 and older. In May 2022, that emergency use authorization (EUA) was extended to those 12 and older. ACP has supported the previous ACIP recommendations. Use of the Pfizer-BioNTech COVID-19 vaccine among persons aged 12-15 as well as an additional dose of the vaccine for persons aged 12 years and older with certain moderate to severe immunocompromised conditions is still authorized under the FDA’s EUA. At this time, only patients with moderate to severe immunocompromising conditions are recommended to receive an additional dose of mRNA vaccine.

ACP strongly encourages physicians, other health care professionals and patients to get vaccinated against COVID-19. ACP will continue to support calls for the ongoing evaluation of vaccine effectiveness as well as safety monitoring through programs such as the Vaccine Adverse Event Reporting System (VAERS) and V-SAFE, a smartphone-based program that uses text messaging and web surveys to conduct post-vaccination health check-ins for individuals who receive COVID-19 vaccines.

“With the full approval of this vaccine, people should have confidence in its ability to be safe and effective,” said George M. Abraham, MD, MPH, FACP, President, ACP. “The vaccine is scientifically proven with data to support its use and is our best tool to stop the spread of the COVID-19 virus and its variants. We urge everyone who is eligible to get the vaccine and consult with their physician if they have questions or ongoing concerns.”

ACP will continue to monitor the FDA approvals and ACIP recommendations for use of additional COVID-19 vaccines, including the COVID-19 vaccines from Moderna, Inc., and Johnson & Johnson. Those remain authorized only under the previous EUA.

About the American College of Physicians

The American College of Physicians is the largest medical specialty organization in the United States with members in more than 145 countries worldwide. ACP membership includes 161,000 internal medicine physicians (internists), related subspecialists, and medical students. Internal medicine physicians are specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness. Follow ACP on Twitter, Facebook, and Instagram.

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Contact:         Laura Baldwin (215) 351-2668, lbaldwin@acponline.org