Omicron Boosters Are Coming, But They Weren’t Tested in People. Here’s What You Need to Know
But with the fall and winter fast approaching—the seasons when respiratory viruses like SARS-CoV-2 spread even more efficiently, as students return to school and people huddle indoors—getting the booster ready requires a more efficient review and regulatory process. And that includes considering safety and efficacy data from animals, not people.to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections.
Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals. Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them. The FDA has also decided to review the animal study data without consulting its advisory committee again.
While conducting human studies does take more time, Offit says even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful. “You can boost people and measure their neutralizing antibodies two weeks later,” he says. Such information could also be critical in setting realistic expectations for the Omicron booster.
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