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HomeRegulators OK Extra Dose against COVID-19

Regulators OK Extra Dose against COVID-19

U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge, as reported in the Associated Press.

The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers, or other disorders. Several other countries, including France and Israel, have similar recommendations.

It’s harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.

“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.

The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.

Importantly, the FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It’s not an opening for booster doses for the general population.

“This is all going to be very personalized,” cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third 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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