FDA Authorizes Pfizer, Moderna Booster Shots for All American Adults

The Food and Drug Administration (FDA) authorized Wuhan coronavirus booster shots for all U.S. adults, the Administration shared in an announcement on Friday.

All U.S. residents over the age of 18 will be eligible to receive a booster of the Pfizer-BioNTech or Moderna vaccine. The announcement notes that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will convene today to discuss further clinical recommendations.

Today, we amended the EUAs for the Moderna & Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose to be administered to those 18+ years old after completion of a primary vax series with any FDA-authorized/approved #COVID19 vaccine. https://t.co/BpITYtl90d pic.twitter.com/r49GJj5Opo
— U.S. FDA (@US_FDA) November 19, 2021

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock in a statement.

As we covered, the FDA previously authorized boosters for individuals 65 years of age and older, and those at “high risk” of severe COVID-19. Now, all adults can get a booster at least six months after the primary two-dose vaccination series of Pfizer or Moderna.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

Furthermore, the FDA will allow booster shot recipients to “mix and match” which brand they receive for their primary dosage and booster shot dose. For example, recipients of the Pfizer two-dose COVID-19 vaccine could opt for the Moderna booster shot if they choose.

The announcement notes that post-authorization, post-marketing studies are being conducted to “assess known serious risks of myocarditis and pericarditis.” Additionally, both the FDA and CDC have “several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.”