FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants

The BA.4 and BA.5 strains now account for over half of infections in the US, according to the CDC.

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Kris Holt
June 30, 2022 1:16 PM
ORLANDO, FLORIDA, UNITED STATES - 2022/06/24: Blue-capped vials of the two-dose Moderna Covid-19 vaccine for children between 6 months and five years are seen at Nona Pediatric Center in Orlando. On June 18, 2022, the Centers for Disease Control and Prevention (CDC) recommended that all children six months to 5 years of age can receive a COVID-19 vaccine. Florida Governor Ron DeSantis has refused to order vaccine doses for state health departments, making Florida the only state not providing the vaccine for young kids. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
SOPA Images via Getty Images

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer Omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain.

An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an Omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the Omicron variant that caused a significant upswing in COVID-19 cases during the winter.

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However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current Omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the Omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

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