The FDA Just Authorized COVID-19 Vaccine Boosters for Immunocompromised People

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Late last night the FDA gave an emergency-use authorization for immunocompromised people to receive a third COVID-19 vaccine dose. The new authorization will allow for those with certain health to get maximum protection from the shots.

The authorization applies only to the two mRNA vaccines (from Pfizer/BioNTech and Moderna) and only to certain people. Specifically, the authorization allows people with severely compromised immune systems (particularly those who’ve received solid-organ transplants and those who are immunocompromised to a similar degree). 

Both of these vaccines originally received emergency authorization back in December 2020. They’re given in two doses which are administered three or four weeks apart (depending on the specific vaccine). So the new FDA COVID-19 emergency vaccine authorization allows for immunocompromised people to receive a third dose of the mRNA vaccines (sometimes called a booster shot) at least 28 days after their second shot. The FDA does not say anything about an ongoing need for doses after that. The agency also does not give guidance about booster shots for immunocompromised people who may have received the single-shot Johnson & Johnson vaccine.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA commissioner Janet Woodcock, M.D., said 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.”

People who are immunocompromised generally do not get as much protection from the vaccines because their bodies are unable to muster the necessary immune response. So, for this specific group of people, an extra dose can help them get more protection. In fact, booster shots for immunocompromised people were “inevitable,” according to Anthony Fauci, M.D., the nation’s top infectious disease expert. And while experts are closely monitoring the potential need for boosters in the general population, this authorization doesn’t mean the rest of us should expect to get another shot anytime soon.

The Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention (CDC) will meet today to determine how the new authorization should be implemented and who exactly will be eligible to get another dose. Even after receiving a third dose of the vaccine, immunocompromised people will likely need to take extra physical precautions, including maintaining social distancing and wearing masks. The FDA also emphasized that close contacts of people with compromised immune systems should get vaccinated to protect those around them.  



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