FDA advisers request update on omicron COVID shot: Shots

The COVID-19 vaccine will be updated in hopes of targeting omicron strains circulating later this year.

Stephen Felix/AP

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Stephen Felix/AP

The COVID-19 vaccine will be updated in hopes of targeting omicron strains circulating later this year.

Stephen Felix/AP

A panel of Food and Drug Administration expert advisors voted unanimously on Thursday to recommend that the COVID-19 vaccine be updated to target emerging omicron subvariants.

The currently available COVID vaccine is known as the “bivalent” vaccine because it was designed to target both the original strain of the coronavirus and the omicron subvariants that dominated last winter.

But the FDA panel recommended that drugmakers abandon the bivalent design and instead switch to a “monovalent” vaccine that only targets omicron subvariants. The idea is to roll out the newly formulated plans in anticipation of a possible increase in cases this fall.

The committee specifically supported targeting the XBB.1.5 subvariant, which accounts for approximately 40% of new infections in the United States.

In an analysis, FDA scientists said data from vaccine makers indicates that an updated monovalent formulation that targets XBB subvariants “elicits stronger neutralizing antibody responses” against XBB strains than current bivalent vaccines.

“There doesn’t appear to be any particular benefit to a bivalent vaccine,” said Dr. Eric Rubin, a Harvard professor of immunology and infectious diseases who is also a member of the advisory board.

Although there was broad agreement on moving to a monovalent vaccine, there was considerable debate among committee members over whether the COVID-19 vaccine should be treated like the flu vaccine. , which is revamped each year in anticipation of flu season.

“People understand an annual flu shot,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “At this point it may not be annual, but for all intents and purposes it looks like by next fall there will be a further drift away from that. [strain] and we may have to come back here.”

But some worried that drawing too close a parallel with influezna might actually confuse Americans.

“It’s not the flu,” said committee member Dr. Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia. He pointed out that many Americans already have some protection against severe illness from COVID-19 due to prior infection, vaccination, or both.

“I’m all for this vaccine update, but I think we need to define… who really benefits from the booster? Because it’s not everyone,” he said.

It is not yet known who federal officials will recommend to receive the updated omicron vaccine.

During the meeting, the CDC shared data that shows that, since last April, COVID-related hospitalizations and deaths have been low in most groups. But they were disproportionately high among people aged 75 or older, suggesting this group might need extra protection. Those with health conditions like chronic lung disease or diabetes could also have higher risks.

The FDA will now review the committee’s discussion and will likely issue an official vaccine formulation recommendation within days, giving vaccine makers a way forward.

If all goes according to plan, the new vaccines are expected to be available in the fall – around the end of September or the beginning of October.