FDA Panel: Coronavirus Vaccines Need to Target Omicron

FDA Panel: Coronavirus Vaccines Need to Target Omicron

It is the first time the panel has proposed that vaccine makers modify their vaccine doses to target a specific variant.


By a nineteen to two vote, an expert panel of independent scientists and physicians is recommending that the U.S. Food and Drug Administration (FDA) begin rolling out this fall an updated coronavirus booster shot that specifically targets the highly transmissible Omicron variant.

“We have to give serious consideration to a booster campaign this fall to help protect us,” Dr. Peter Marks, head of the FDA’s vaccine division, told the Vaccines and Related Biological Products Advisory Committee on Tuesday, per CNBC.


“The better the match of the vaccine to the circulating strain, we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection,” he continued, adding that the United States likely faces a Covid outbreak this fall and winter as the virus continues to mutate into more contagious subvariants.

It is the first time the panel has proposed that vaccine makers modify their vaccine doses to target a specific variant. Reports indicate that the FDA will likely accept the committee’s recommendation.

“Given that state of evolution, we are going to be behind the eight ball if we wait longer,” noted panel member Dr. Mark Sawyer, a professor of pediatrics at the University of California San Diego.

However, panel member Dr. Cody Meissner admitted that he is concerned that there isn’t enough safety data regarding how changing the vaccines’ composition might impact heart inflammation, or myocarditis, a side effect sometimes seen with current Covid vaccines.

“We need more study or research into what is the association with vaccines and myocarditis,” he said.

A committee that advises the World Health Organization (WHO)—the Technical Advisory Group on Covid-19 Vaccine Composition—appears to agree that the currently available vaccines need to be updated to include an Omicron-based viral target.

“I think most people think that continuing to vaccinate with the same product is not the optimum way to get a breadth of response,” Kate O’Brien, the WHO’s technical lead for vaccines, told STAT.

“We’re not trying to say: Put Omicron in it because we think Omicron is what’s going to be around for the rest of time. What the composition committee is saying is: We think that what will protect people best against whatever is going to come in the future is a broad immune response. And for the vaccines, the variant that is most different on the evolutionary tree from the ancestor strain, the index variant, is Omicron. That’s why they’re recommending Omicron,” she continued.

Ethen Kim Lieser is a Washington state-based Finance and Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek, and Arirang TV. Follow or contact him on LinkedIn.

Image: Reuters.