FDA Authorizes COVID-19 Booster Shots for People Who Are Immunocompromised

Late on Thursday evening, the Food and Drug Administration (FDA) authorized booster doses of COVID-19 vaccines from Pfizer-BioNTech and Moderna, specifically for people who are immunocompromised.  

The shot, which would be a third dose, can be administered as soon as 28 days after the two-dose regimen of the same vaccine.

In a statement released on Thursday night, acting FDA commissioner Janet Woodcock explained the agency’s decision: “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… people who are immunocompromised…have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19.” 

For now, there is no booster dose recommendation for people who received the one-dose Johnson & Johnson (J&J) vaccine. However, the National Institutes of Health (NIH) is currently conducting studies on booster shots, including for people who received the J&J.  

“Preliminary data should be available in September,” an NIH spokesperson tells Verywell.

 Who Is Considered Immunocompromised? 

The FDA says that "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise" are currently eligible for boosters.  

Anticipating the FDA’s action, Centers for Disease Control and Prevention (CDC) director Rochelle Walensky, MD, MPH, discussed the move at a White House reporter’s briefing on Thursday. 

"Emerging data show that certain people who are immune compromised, such as people who have had an organ transplant and some cancer patients, may not have had an adequate immune response to just two doses of the [Pfizer and Moderna] COVID vaccine,” Walensky said. 

It’s important to remember that boosters are not the only protection people who are immunocompromised need to prevent COVID-19. According to the FDA, masks and social distancing continue to be necessary. 

“[Immunocompromised] patients should be counseled to maintain physical precautions to help prevent COVID-19,” Woodcock says. “In addition, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones.”

CDC Signoff

A CDC advisory committee called the Advisory Committee on Immunization Practices (ACIP) voted on Friday to recommend the boosters for immunocompromised people. A CDC spokesperson tells Verywell that while healthcare providers could give the booster as soon as the FDA authorized it, the ACIP decision will prompt the CDC director to sign a “decision memo” to make the recommendation official. This allows healthcare providers to be reimbursed for administering the shots. 

The Future of COVID Booster Shots

“Now that the FDA has authorized boosters for immunocompromised people, it is possible that a booster shot may be recommended in the future for others,” Albert Shaw, MD, PhD, an infectious disease specialist at Yale University School of Medicine, tells Verywell. “But right now, not everyone needs a booster.”

According to Shaw, for most people, the Pfizer and Moderna vaccines are proving quite effective against the virus and its even variants months after vaccination. And before the general population moves forward with third doses in the U.S, other parts of the world need their shots.

“The most important thing is for unvaccinated individuals to become vaccinated,” Shaw says. “We already know that vaccines are effective—including against the Delta variant currently circulating widely—particularly at preventing serious illness resulting in hospitalization or death.”

Infectious disease experts urge people who are not immunocompromised to wait for further updates on boosters to see the exact recommendations from the agencies reviewing the data. 

“The FDA and CDC are evaluating the latest data from vaccine studies on the need for boosters for the general population,” Matthew Laurens, MD, MPH, a vaccine researcher and pediatric infectious disease specialist at the University of Maryland School of Medicine, tells Verywell. “We’re not there at this point, but we will likely see the recommendations continue to evolve with the science.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.