En español | A Centers for Disease Control and Prevention (CDC) advisory panel voted unanimously on Aug. 13 in favor of a decision to allow moderately and severely immunocompromised individuals to receive a third dose of the Pfizer-BioNTech and Moderna coronavirus vaccines. The vote happened one day after the Food and Drug Administration (FDA) expanded the emergency use authorizations (EUA) for the two vaccines.
The change affects a small population whose immune systems are weakened from a solid organ transplant or other conditions that have an equally crippling effect on the immune system — less than 3 percent of American adults, according to CDC Director Rochelle Walensky, M.D., who signed off on the panel’s recommendation hours after the vote.
“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 statement. “Today's action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19.”
The Moderately and Severely Immunocompromised
Populations that are considered to be moderately and severely immunocompromised:
- People who have been receiving active cancer treatment for tumors or cancers of the blood.
- People who received an organ transplant and are taking medicine to suppress the immune system.
- People who received a stem cell transplant within the last two years or are taking medicine to suppress the immune system.
- People with a moderate or severe primary immunodeficiency (such as DiGeorge syndrome and Wiskott-Aldrich syndrome).
- People with advanced or untreated HIV infection.
- People undergoing treatment with high-dose corticosteroids or other drugs that may suppress the immune response.
People should talk to their healthcare provider about whether getting an additional dose is appropriate for them, the CDC says.
Additional shot enhances protection
People who have undergone solid organ transplantation or have other immune-weakening conditions have a reduced ability to fight off infections and are more vulnerable to falling ill from one, the FDA explains. And data presented in the Aug. 13 CDC advisory committee meeting show that a two-dose COVID-19 vaccine regimen is less effective in immunocompromised individuals. This population is also more likely to transmit the virus to household contacts and to get a breakthrough infection that lands them in the hospital.
A third dose of the vaccine, however, could give the immune system the boost it needs to fend off COVID-19, which is a particular concern as the highly contagious delta variant rips through many communities across the country.
A study published this week in The New England Journal of Medicine found that solid organ transplant patients who were given a third vaccine dose saw a significant boost in antibody response against the coronavirus, compared with those given a placebo dose. Some expected side effects were slightly more common in those who received the third dose than in those who received the placebo, however no serious adverse events were reported after the administration of the third dose, the study's researchers write.
The amended EUA allows for the third dose to be administered at least 28 days after completion of the two-dose regimen of the same vaccine to individuals 18 years or older for Moderna, and 12 years or older for Pfizer-BioNTech. It does not apply to the single-shot Johnson & Johnson vaccine, as health officials say there is not enough data to support an additional dose at this time.
A prescription will not be required for immunosuppressed individuals to receive the additional dose, health officials said. If you’re unsure whether a third dose is recommended for you, “send your provider an email or give them a call,” says infectious disease expert William Schaffner, M.D., a professor of medicine at Vanderbilt University School of Medicine.
In addition to the vaccine, experts also stress the need for immunocompromised people to keep up with prevention measures, including wearing a mask in public and avoiding crowds and poorly ventilated spaces.
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Others don't need booster shots yet
In the FDA's news release announcing the EUA expansion, Woodcock reiterated that “other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.” However, COVID-19 booster shots for the rest of the population are likely inevitable, experts say. It's just not clear when they will be needed or who will be next in line to receive them.
"We do not believe that others, elderly or nonelderly, who are not immunocompromised need a vaccine right at this moment,” Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said on Thursday in a news briefing. “But this is a dynamic process and the data will be evaluated.”
When the decision is made to open up boosters to a larger portion of the population, Fauci said officials are “ready to do it and do it expeditiously.” White House Coronavirus Response Coordinator Jeffrey Zients emphasized that the country has ample supply and that “people will be able to get a booster in a fast and efficient way."
Editor's Note: This story has been updated from its original version to reflect new information.
Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press Foundation.