The U.S. Food and Drug Administration (FDA) is probably ready to amend the Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines so people with compromised immune systems can get a third (booster) dose, according to sources familiar with the plans.
In July, a panel of advisors to the U.S. Centers for Disease Control and Prevention (CDC) urged the FDA to approve an extra dose for immunocompromised people.
Experts say there is growing evidence that many immunocompromised patients are still vulnerable to COVID-19 even after vaccination because they may not mount an effective immune response to the shots, according to TODAY.
The CDC says an estimated 2.7% of American adults are immunocompromised.
However, it is unclear which groups would be covered under the expected FDA approval. Immunocompromised patients include those who have HIV, cancer, among others and those who underwent organ transplantation.
Organ transplant recipients must take medications that suppress their immune systems so their bodies do not reject the new organ(s). One study has already found that some immunocompromised patients never developed antibodies to COVID even after vaccination, while others developed very low levels of protection.
The study, conducted by the researchers of Johns Hopkins University, found that a third dose increased their antibody levels.
A booster dose of COVID vaccines would likely be welcome to people who failed to have a good response from the first two shots. Doctors advise such patients to continue with social distancing and mask-wearing despite getting the shots.
The CDC’s panel of advisors is scheduled to meet Friday. They may vote on whether to officially recommend a third dose for immunocompromised people. The panel’s vote is needed before health professionals could start prescribing the extra dose.
Such a vote is done after the FDA takes regulatory action, such as the expected amendment to the emergency use authorization, per Today.
Last week, the Mississippi Department of Health recommended immunocompromised people to receive an additional vaccine dose. The recommendation came even though health officials had not yet signed off on it. This story appeared on NBC News and TODAY.
