Omicron Boosters Are Coming, But They Weren’t Tested on People

With nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public.

White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters.

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.