FDA OKs 3rd COVID-19 Vaccine Dose for the Immunocompromised

FDA amends the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for an additional dose in immunocompromised individuals.

The agency determined that the vulnerable group may benefit from a third dose of the respective COVID-19 vaccines as the US enters into another wave of the pandemic. 

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement. 

“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,” Woodcock continued. 

Individuals who are immunocompromised are especially vulnerable to infections, including COVID-19.

FDA evaluated information on the use of a third vaccine dose in immunocompromised individuals, specifically solid organ transplant recipients or those diagnosed with conditions considered to have an equivalent level of immunocompromise. 

The agency stated that these patients should be counseled to maintain physical precautions to help prevent the virus. And those in close contact with immunocompromised individuals should get vaccinated. 

Additionally, FDA recommends that immunocompromised individuals discuss monoclonal antibody treatment options with their healthcare provider if they are infected or exposed to the virus. 

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss further clinical recommendations regarding immunocompromised individuals.

Notably, this authorization does not apply to individuals that are not immunocompromised. 

Throughout the pandemic, FDA has authorized monoclonal antibody treatments for emergency use for both adult and pediatric patients.  

In February, FDA authorized Eli Lilly & Company’s combination COVID-19 antibody treatment. And last week, the agency expanded its authorization for Regeneron’s COVID-19 antibody cocktail, REGEN-COV.