FDA Advisors Propose To Replace Primary COVID Shots With New Bivalent Shots
The Food and Drug Administration’s independent advisory committee unanimously recommended replacing the current original COVID vaccines used in the U.S. for primary shots with new bivalent omicron shots authorized as boosters, reports said.
The committee also considered the proposal for annual COVID vaccination, however, didn’t vote on it.
FDA generally accepts the advisors’ recommendation, and an approval from the regulator would result in phasing out the current regime against the COVID-19 strain, that emerged in 2019 in Wuhan, China.
The move is expected to increase vaccine intake in the U.S. population by relaxing the complex nature of having two types of COVID-19 vaccines and different schedules for different age groups.
At present, the drug regulator has authorized drugmakers’ vaccines developed in 2020 against the original COVID-19 strain for the first two primary shots. These include vaccines developed by drugmakers Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson’s Janssen.
Pfizer and Moderna have developed bivalent omicron shots, which were authorized by the FDA only as a booster to fight off Omicron’s BA.4 and BA.5 subvariants that emerged in the country last year.
The committee reportedly has voted 21-0 to back the proposal to simplify and harmonize the U.S. Covid vaccination program with a single composition for primary shots and boosters.
As per the committee recommendation, the drugmakers’ bivalent omicron shots that target the original strain as well as the omicron subvariants would be used for the entire vaccination process, replacing the initial vaccines.
The FDA reportedly had decided last year to update the initial COVID vaccines in consultation with its advisers.
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