Fifth COVID-19 Vaccine Shot May Be Needed in Fall: FDA Official

Hours after the Food and Drug Administration authorized a fourth shot of the Moderna and Pfizer COVID-19 vaccines for all Americans 50 and older, an FDA official said a fifth shot may be needed in the fall.

"I don't want to shock anyone but there may be a need for people to get an additional booster in the fall, along with a more general booster campaign if that takes place, because we may need to shift over to a different variant coverage," Dr. Peter Marks, head of the FDA center that regulates vaccines, told reporters on a call on March 29.

The fresh emergency use authorization is for a fourth shot for Americans 50 and up and a fifth shot for people as young as 12 with weakened immune systems.

Moderna and Pfizer are testing vaccine formulations that specifically target Omicron.

"It may be that a decision is made that rather than what we currently have, the vaccines we currently have-which are called vaccines against the prototype virus-that we will move to a vaccine that is either against one of the variants-whether it's Omicron, Beta, or Delta, or something else, I can't say right now that's for discussion-or whether it's some mix of different ones," Marks said.

The worries stem in part from the main vaccines being built on a technology, messenger RNA, that had never been cleared for use before the pandemic, with others noting that other vaccines provide sufficient protection through shots administered annually, or at less frequent intervals.

If repeated boosters are administered, "We will end up potentially having problems with immune response and immune response may end up not being as good as we would like it to be, so we should be careful in not overloading the immune system with repeated immunization," Marco Cavaleri, the European Medicines Agency's head of vaccines strategy, told a briefing in January.
 

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