FDA Permits Third COVID-19 Vaccine Dose for Immunocompromised People

This article was originally published on InfectionControlToday.com.

The US Food and Drug Administration (FDA) announced Thursday it has authorized a third dose of either the Pfizer/BioNTech or Moderna mRNA COVID-19 vaccines for patients with compromised immune systems.

In a press release, Acting FDA Commissioner Janet Woodcock, MD, said that yesterday’s ruling “allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”

“The FDA expanded the emergency use authorization (EUA) for both the Pfizer/BioNTech and Moderna vaccines. That decision will then be evaluated by the CDC’s Advisory Committee on Immunization Practices (ACIP) this afternoon. That’s expected to be a formality as the committee in July urged the FDA to authorize a third dose of the vaccine for the immunocompromised. The booster shots could become available for immunocompromised adults as soon as tonight.

The ruling was primarily made to benefit organ transplant patients but others with compromised immune systems, such as those battling cancer and HIV, would also be eligible for booster shots. About 2.7% of adults in the United States are immunocompromised, according to the CDC. However, recent ACIP data show that the immunocompromised make up about 44% of COVID-19 breakthrough cases.

The FDA encourages such patients to explore treatment options with their health care providers should they contract COVID-19 or be exposed to someone with COVID-19.