FDA to streamline authorization of Omicron-specific vaccine

The director of the Centers for Disease Control and Prevention said Sunday that federal regulators are in talks to fast-track the authorization process for an Omicron-specific vaccine — as the concerning new variant has spread to at least 15 states.

Dr. Rochelle Walensky said that the Food and Drug Administration was exploring whether an expedited review would be possible if a new vaccine was necessary for the variant.

“I would have to defer to the FDA, but they’re already in conversations about streamlining the authorization of this, of an Omicron-specific vaccine, partially because much of the vaccine is actually exactly the same and really, it would just be that mRNA code that would have to change,” Walensky told anchor Martha Raddatz on ABC’s “This Week.”

“So those conversations are ongoing, and certainly, FDA will move swiftly and CDC will move swiftly right thereafter,” she added.

Walensky said that Omicron has already been confirmed in at least 15 states so far.

“We know we have several dozen cases and we’re following them closely. And we are every day hearing about more and more probable cases, so that number is likely to rise,” Walensky said.

The Omicron variant has spread to at least 15 states.

California was the first state to confirm a case of the variant on Wednesday. Colorado, Connecticut, Hawaii, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Pennsylvania, Utah, Washington and Wisconsin have all since announced cases.

Though it’s unclear how effective the current COVID-19 vaccines will be against the variant, Walnesky urged Americans to get vaccinated and their booster shots if eligible.

“I think the next six months really depends on how we mobilize together to do the things that we know work,” she said. “We know from a vaccine standpoint that the more mutations a single variant has, the more immunity you really need to have in order to combat that variant, which is why right now we’re really pushing to get more people vaccinated and more people boosted to really boost that immunity in every single individual.

COVID-19 test center.
California was the first state to confirm a case of the Omicron variant.
Mario Tama/Getty Images

“We’re really hopeful that our vaccines will work in a way that even if they don’t prevent disease entirely, prevent infection entirely, that they can work to prevent severe disease and keep people out of the hospital,” she said.

Experts said it’s likely that omicron is more infectious, though it’s unclear if the variant causes more serious disease.