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

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. 

The White House has been aiming to roll out boosters to all American adults for months now. Days after the FDA authorized the first additional doses of the COVID-19 vaccine (both Pfizer and Moderna) for immunocompromised people in August, the White House announced a plan to make boosters available to most people beginning in September. But ultimately the FDA and CDC voted to limit eligibility to people at higher risk of contracting COVID-19 or experiencing severe illness, as SELF reported. 

While this ended up covering a large swath of the population, it still excluded many and was more challenging for public health officials to message around. “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,” Dr. Marks explained in the FDA press release.

Despite the demand for booster shots, a number of experts have maintained that healthy people at average risk of contracting and low risk of getting severely sick from COVID-19 don’t need them, as SELF has reported. Some experts expressed skepticism that waning immunity data was strong enough to support making booster shots available to the general public, while others questioned the ethics of offering boosters here in the U.S. while there is still such poor availability for initial vaccination in many countries. 

Related:

• COVID-19 Booster Shot Side Effects: Here’s What to Expect, According to a New CDC Study
• I Couldn’t Wait to Get My Kids Vaccinated Against COVID-19. Here’s Why.
• The Pandemic Is Still Going On—And Immunocompromised People Need You to Keep Caring