FDA Advisers Recommend Boosters Targeting Omicron As Subvariants Spread

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The Centers for Disease Control and Prevention said omicron subvariants BA.4 and BA.5 together made up the majority of U.S. COVID cases last week, while a panel of Food and Drug Administration experts recommended fall booster shots tweaked to target omicron variants.

The omicron subvariant BA.2.12.1 accounted for 42% of cases the week ending on June 25. But the subvariants BA.4 and BA.5 combined accounted for 52.3% of COVID infections, according to the CDC.

The FDA’s Vaccines and Related Biological Products Advisory Committee met Tuesday to discuss modified versions of COVID vaccines.

Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, told the committee the U.S. is expected to face a challenge this fall, with half of Americans vaccinated with only two vaccine doses and immunity declining in the population.

“That combination of waning immunity combined with the potential emergence of novel variants during a time this winter when we will move inside as a population increases our risk of a major COVID-19 outbreak,” Marks said.

“For that reason, we have to give serious consideration to a booster campaign this fall to help protect us,” Marks continued.

Marks said vaccines that match the evolving virus give the best protection against deaths and hospitalizations.

“The better the match of the vaccine with the circulating strain we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection,” Marks said.

Members voted 19-2 in favor of recommending COVID boosters that target omicron.

While the vote is not binding, the FDA usually accepts recommendations from its advisers.

“This doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for potential need for boosters in the fall,” Dr. Amanda Cohn said following the vote.

Dr. Ofer Levy, another member of the panel, noted that fall is only a few months away.

“We face a time-sensitive decision. If we’re going to have something better in the fall the decision has to be made very soon and so I believe it was more likely than not the benefit outweighed the risk of including an omicron component,” Levy said.

While committee members agreed an updated booster is needed, they didn’t specify which omicron component would be targeted. The FDA favors a booster that would combine the original vaccine and also would fight BA.4 and BA.5, according to The New York Times.

Moderna and Pfizer have been working on boosters that combine the original shot with the omicron variant, but not those subvariants.

In early June, Moderna said preliminary results showed its updated booster was offering an eightfold increase in antibodies targeting omicron, according to The Associated Press.

Pfizer and its partner BioNTech announced Saturday their booster also elicited a strong immune response against omicron.

Earlier this month, the CDC recommended COVID vaccines for children under the age of 5.

Researchers from Imperial College London found nearly 20 million lives were saved by COVID vaccines during the first year they became available.


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