FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Individuals

FDA announced on August 12, 2021 that it has amended the Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines so that certain immunocompromised people 18 years or older (ages 12 and over for Pfizer-BioNTech) can receive an additional dose of the vaccine, administered at least 28 days after the two-dose regimen of the same vaccine. Specifically, the agency mentions solid organ transplant recipients and people with conditions that are considered an equivalent level of immunocompromise. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting on Friday to discuss clinical recommendations regarding immunocompromised people.

According to FDA, people who are immunocompromised in a similar way to those who have had solid organ transplants are especially vulnerable because they have less of an ability to fight infections. A third dose of the Pfizer-BioNTech or Moderna vaccines may increase the protection for these people, the agency said in a press release. FDA also recommends that immunocompromised individuals who are exposed to COVID-19 should discuss monoclonal antibody treatment options with their doctor.

“The country has entered yet another wave of the COVID-19 pandemic, and [FDA] is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, [FDA] determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna [v]accines,” said Acting FDA Commissioner Janet Woodcock, in a press release. “Today’s action 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. [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.”