FDA advisory panel votes to reformulate COVID-19 boosters to target Omicron

An FDA advisory panel votes to reformulate this fall's COVID-19 booster shots to target Omicron subvariants. File Photo by Debbie Hill/UPI
An FDA advisory panel votes to reformulate this fall's COVID-19 booster shots to target Omicron subvariants. File Photo by Debbie Hill/UPI | License Photo

June 28 (UPI) -- A federal advisory panel voted Tuesday to boost this fall's COVID-19 shots against the Omicron viral variant.

The Food and Drug Administration's advisory panel voted 19-2 to reformulate the booster vaccines against Omicron's BA.4 and BA.5 subvariants, which now account for half of all COVID-19 cases in the United States, according to the Centers for Disease Control and Prevention. While panel members said they wanted more data Tuesday, they felt comfortable the changes would be safe.


The new boosters will target the original COVID-19 strain and the Omicron strain in one shot. Moderna announced its revamped COVID-19 booster shot, which produces a stronger immune response to the Omicron variant than its original booster, should be available in late August.

Pfizer released a statement shortly after the vote.

"The data presented and discussed at today's meeting underscore that we can swiftly put into place a program and validate the process," the statement said. "We believe that we've found possible solutions as we head into this next chapter of the pandemic and will continue to share our available data to health experts and regulators, in order to bring an Omicron-adapted booster to the world as quickly as possible."


The Omicron variant of COVID-19 has been dominant in the United States since it overtook the Delta variant in last winter's surge. And cases are expected to surge again toward the end of this year.

"For the summer, going into the winter, I expect these viruses to be out there at relatively high levels," said Dr. Alex Greninger, assistant director of the University of Washington's clinical virology laboratory.

Scientists warn the new Omicron subvariants are more contagious forms of COVID-19 that could cause breakthrough infections, despite vaccinations and immunity from past infections. But researchers are not sure if the infections are more severe or could lead to more hospitalizations or death.

The FDA estimates about half of Americans have received at least one booster dose, which provides less protection as time goes on.

"That combination of waning immunity, combined with the potential emergence of novel variants, during a time this winter when people move inside as a population increases our risk of a major COVID-19 outbreak," said Dr. Peter Marks, who heads the FDA's division that regulates vaccines.

"For that reason, we have to give serious consideration to a booster campaign this fall to help protect us."

Latest Headlines