FDA recommends modified COVID-19 boosters targeting omicron subvariants

The U.S. Food and Drug Administration gave its formal recommendation Thursday to update the available COVID-19 vaccines to protect against strains of the omicron variant.

FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks said in a statement that the updated vaccines would be used as boosters this fall and winter in anticipation of future surges driven by the highly contagious variant and its subvariants.

The current composition of the available vaccines would remain unchanged for an initial vaccine series, Marks said, because the available vaccines still provide a broad amount of protection from the virus’ worst outcomes.

According to a study published in April in the medical journal JAMA Network Open, COVID vaccinations prevented an estimated 1.5 million cases, 72,000 hospitalizations and 19,000 deaths in California alone through mid-October 2021.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” Marks said.

Marks noted that studies of vaccine effectiveness have found that protection begins to wane after a few months, necessitating the initial need for booster doses and the potential for variant-specific versions.

The available COVID-19 vaccines are currently fully approved or approved for emergency use for everyone aged 6 months or older.

Booster vaccine doses are also encouraged for everyone 5 years old or older, provided a vaccine recipient completed their initial vaccine series at least five months ago.

According to Marks, vaccine manufacturers have already submitted clinical trial data to the agency for a booster vaccine formulated against the BA.1 omicron variant.

The agency has asked manufacturers to also conduct clinical trials and submit data for the effectiveness of a vaccine formulated to combat the BA.4 and BA.5 omicron subvariants.

“In keeping with our commitment to transparency, the FDA will communicate future plans pertaining to the potential authorization or approval of COVID-19 vaccine booster doses with an omicron component,” Marks said.

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