COVID-19 vaccines: Moderna, Pfizer asks FDA for approval of boosters that target omicron

Moderna has asked the U.S. Food and Drug Administration to authorize its COVID-19 booster shot that targets the highly contagious omicron subvariant, along with the original virus.

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The call for authorization of the bivalent vaccine comes after Pfizer and BioNTech made a similar request of the FDA on Monday.

A bivalent vaccine combines vaccines that fight more than one version of a virus.

Moderna is asking the FDA to approve the booster for those ages 18 and older. Pfizer’s booster would include everyone ages 12 and older.

If it is approved by the FDA, the Biden administration is planning to distribute the modified shots in September as part of its fall booster campaign. Pfizer says it would be able to ship doses immediately, while Moderna said it has ramped up production for a September delivery of the vaccines.

In June, Moderna announced that the booster triggered an increase in antibodies that fight the BA.4 and BA.5 omicron subvariants in those who had already had the virus or had a previous vaccination.

Instead of waiting for results from human trials, the FDA asked the drug companies to initially submit only the results of tests on mice, NPR reported last week.

The FDA will rely on those results — along with the human neutralizing antibody data from earlier BA.1 bivalent booster studies — to decide whether to authorize the boosters, NPR reported.

“We’re going to use all of these data that we’ve learned through not only this vaccine, but decades of viral immunology to say, ‘The way to be nimble is that we’re going to do those animal studies,’” Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine in Tucson, told NPR. “We’re really not going out too far on a limb here.”