WASHINGTON — The Food and Drug Administration announced late Thursday that transplant recipients and other people with weakened immune systems will be allowed to receive a third dose of the COVID-19 vaccine.
The announcement applies to millions of Americans who are vulnerable to COVID-19 because of organ transplants, certain types of cancers and other disorders, according to The Associated Press. The third dose will come from the Pfizer and Moderna vaccines, the FDA said in a news release.
“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 said in a news release. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19.
Today, FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals. https://t.co/MYoTvX82lM pic.twitter.com/cqwF5j8pYp
— U.S. FDA (@US_FDA) August 13, 2021
“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.”
Patients who qualify can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot, according to the FDA.
The agency did not mention immune-compromised patients who received the single-dose Johnson & Johnson vaccine, according to the AP.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday “to discuss further clinical recommendations regarding immunocompromised individuals.”
“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 Commissioner @DrWoodcockFDA
— U.S. FDA (@US_FDA) August 13, 2021
The panel also is likely to urge patients to speak with their doctors about the additional shots, The Washington Post reported. CDC director Rochelle Walensky is expected to sign off on the decision Friday afternoon, the newspaper reported.
Thursday’s action does not apply to people who are not immunocompromised, the FDA said in its news release.
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