FDA May OK COVID Booster for Vulnerable Adults Before Weekend: Media

Brenda Goodman

August 11, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The US Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next 2 days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Thursday, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn't develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn't officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or "full approval."

It's unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn't have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC's Advisory Committee on Immunization Practices (ACIP) meets again on Friday and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation's doctors.

The committee's recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP's recommendations.

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