FDA to Accept 3rd Dose of Vaccine for Immunocompromised People

The Food and Drug Administration is set to change emergency use authorizations for Pfizer and Moderna Covid-19 vaccines on Thursday to allow people with weakened immune systems to get a third dose, according to two sources close to the plans.

The move would come after a group of advisers from the Centers for Disease Control and Prevention met in July and urged action on additional doses for immunocompromised adults.

Doctors say it is increasingly clear that many such patients are still vulnerable to Covid after vaccination, as they may not develop an effective immune response to injections.

An estimated 2.7 percent of adults in the United States are immunocompromised, according to the CDC. It is not known which groups would be covered by the FDA’s expected action. Immunocompromised patients include organ transplant recipients, people undergoing cancer treatment, and people living with HIV, among others.

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Organ transplant recipients, for example, must take drugs to suppress their immune system so that their body does not reject the new organs. A small study of these patients found that the majority had never developed antibodies to the coronavirus after vaccination. The others only developed low levels of protection.

In this study, from Johns Hopkins University, a third dose increased their antibody levels.

A boost in immunity would likely be welcome for those who never had a good response from the first two strokes, as doctors continued to advise these patients to continue to physically distance themselves and use a mask despite the vaccinations. .

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The emergency use authorization does not include fully vaccinated, otherwise healthy people; the Pfizer and Moderna vaccines have been shown to be very effective in preventing hospitalization and death in them.

The CDC’s advisory group is due to meet on Friday, when it can vote on whether to officially recommend a third injection for people with immunosuppression. Panel approval is required before doctors can begin prescribing additional doses.

Such a vote is only taken after the FDA has taken regulatory action, such as modifying the expected emergency use authorization.

Last week, the Mississippi Department of Health recommended that immunocompromised people receive an additional dose of the vaccine, despite federal health officials not yet approving it.

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