The FDA Just Authorized COVID-19 Vaccine Booster Shots for All Adults

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All adults in the U.S. will soon be able to get a COVID-19 vaccine booster shot. On Friday morning, the U.S. Food and Drug Administration (FDA) authorized both the Pfizer/BioNTech and Moderna COVID-19 vaccine booster shots for all people ages 18 and over.

The FDA decided to expand the emergency use authorization (EUA) for the Pfizer and Moderna boosters that previously covered only certain high-risk groups, such as those with underlying medical conditions or ages 65 and older. Now, the FDA says that any adult who has been fully vaccinated with any FDA-authorized COVID-19 vaccine—Pfizer, Moderna, or Johnson and Johnson—should be eligible to get a booster. People who got the two-dose Pfizer or Moderna vaccine may get a booster starting six months after their second dose, while people who got the single-dose J&J vaccine may get a booster starting two months after their shot, according to the FDA press release.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves,” Janet Woodcock, M.D., said in the FDA press release. “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.”

The FDA made its decision after weighing the evidence on the efficacy and safety of the half-dose booster shots, including trial data that Pfizer and Moderna submitted in applications to expand their respective booster EUAs this month. In those clinical trials, both shots demonstrated that they effectively boosted the immune system’s antibody response against the SARS-CoV-2 virus one month later. “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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA release.

The last regulatory step before people can actually get the shots is an official sign-off from the Centers for Disease Control and Prevention (CDC) panel of experts that issues recommendations on administering vaccines. The CDC’s Advisory Committee on Immunization Practices (ACIP), scheduled to meet later today, is expected to vote in agreement with the FDA’s decision. Assuming the ACIP votes in favor of recommending the booster (and that CDC director Rochelle Walensky, M.D., M.P.H., endorses the ACIP’s recommendation), newly eligible individuals can start getting their booster shots as soon as this weekend.

The FDA has been under pressure to make boosters more widely available. Recently, officials in a number of states and cities (including Arkansas, California, Colorado, New Mexico, New York City, and West Virginia) moved ahead in expanding booster access to all adults—without federal guidance—in hopes of preventing a winter surge, as The Washington Post reports. The decision also comes amid reports that senior members of the Biden administration have been pushing federal health officials and CDC advisers to endorse boosters for all adults ahead of the holiday season, according to The Washington Post.

https://www.self.com/story/fda-authorized-pfizer-moderna-covid-19-booster-shots, GO TO SAUBIO DIGITAL FOR MORE ANSWERS AND INFORMATION ON ANY TOPIC

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