FDA OKs Pfizer-BioNTech, Moderna Boosters for Immunocompromised


The U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization for COVID-19 vaccines produced by Pfizer, BioNTech and Moderna to allow a third shot for immunocompromised patients.

The anticipated amendment was announced late Thursday night. Specifically, the amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that are considered to have an “equivalent level of immunocompromised,” the FDA said. 

The U.S. Centers for Disease Control and Prevention will meet today to discuss additional clinical recommendations regarding immunocompromised individuals. A recommendation from that agency could come Monday.

People considered immunocompromised have a reduced ability to fight the COVID-19 infection despite receiving both doses of the mRNA vaccines authorized against the viral pandemic. Research from Johns Hopkins University found that people considered immunocompromised are 485 times more likely to end up in the hospital or die from Covid-19 than the general vaccinated population. These individuals, estimated at 9 million people, have a tough time fighting any kind of infection. 

After reviewing clinical data, the FDA amended the EUA for those vaccines as it was determined that a booster shot received about six months after the second injection could provide an increased level of protection for those patients. The FDA also recommended that those in close contact with the patients who fall under this definition should also receive the vaccination to boost the level of protection around them.

Acting FDA Commissioner Janet Woodcock noted that the country is witnessing a new wave of COVID-19 infections, primarily driven by the Delta variant. She said the agency is “especially cognizant” that immunocompromised individuals are at risk for severe disease from COVID-19 infection and may benefit from a third jab. 

“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. 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 said in a statement Thursday night.

The amended EUA does not apply to individuals who are not considered immunocompromised. 

In addition to the authorization of a third jab for immunocompromised patients, the FDA also recommends that, for those individuals, if exposed to the COVID-19 virus, they should discuss the use of monoclonal antibody treatments with their healthcare providers. Last month, Regeneron's REGEN-COV antibody treatment was authorized as a preventative treatment for disease progression after exposure to the SARS-CoV-2 virus. 

Back to news