FDA approves COVID booster for those with weak immune systems

People with highly compromised immune systems will be eligible to get a COVID-19 booster shot, the Food and Drug Administration announced late Thursday.

Transplant recipients and others with severely weakened immune systems who have had two doses of the Pfizer or Moderna vaccine will be eligible for a booster under an emergency-use authorization.

The late-night announcement came as the delta variant continues to surge.

Several million Americans who are especially vulnerable because of organ transplants, certain forms of cancer or other disorders will be eligible for the third inoculation. The U.S. joins several other countries, including Israel and France, in making the move.

Dr. Yomaris Pena, Internal Medicine Physician with Somos Community Care at a COVID-19 extracts the Pfizer COVID-19 Vaccine out of a vial at a vaccination site at the Corsi Houses in East Harlem.(AP Photo/Mary Altaffer, File)
Dr. Yomaris Pena, Internal Medicine Physician with Somos Community Care at a COVID-19 extracts the Pfizer COVID-19 Vaccine out of a vial at a vaccination site at the Corsi Houses in East Harlem.(AP Photo/Mary Altaffer, File) (Mary Altaffer/AP)

The FDA’s decision only applies to high-risk people, thought to be no more than 3% of U.S. adults. There is no plan yet for a booster-shot program for the general population.

People whose immune systems are suppressed by certain medications and diseases don’t always get the same protection as otherwise healthy people, and some studies suggest a third shot will provide an extra layer of defense against the coronavirus.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.

Eligible people should wait at least 28 days after their second Pfizer or Moderna shot to receive a third dose, the FDA ruled. The agency made no mention of immunocompromised patients who got the single-dose Johnson & Johnson vaccine.

The FDA decision comes as the highly contagious delta variant surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.

“This is all going to be very personalized,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University and head of a National Institutes of Health study of extra shots for organ recipients. For some people, a third vaccine dose “increases their immune response. Yet for some people it does not seem to. We don’t quite know who’s who yet.”

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