One day after the US Food and Drug Administration (FDA) greenlighted updated Covid-19 vaccine boosters from Pfizer/BioNTech and Moderna, the director of the US Centers for Disease Control and Prevention, Dr. Rochelle Walensky, signed off Thursday on the CDC’s recommendation of the boosters.
Dr. Walensky endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) – the agency’s independent vaccine advisers – recommendations for use of updated mRNA boosters for Americans this fall.
Earlier in the day, ACIP voted 13 to 1 to recommend that anyone 12 or over get updated Covid-19 boosters formulated to target the Omicron subvariants dominating US infections.
According to pharma giants which began shipping the new doses after getting FDA’s authorization on Wednesday, Walensky’s decision means the vaccines could be available by Friday.
It also pushes forward the fall booster campaign federal officials announced hoping to protect Americans against the expected winter surge and reduce COVID-19 deaths later this year.
FDA also had the fall campaign in mind when calling for boosters that specifically address the Omicron variants. Both Pfizer and Moderna boosters contain spike proteins targeting the BA.4 and BA.5 Omicron subvariants that have dominated in the US this summer on top of the original coronavirus strain.
It’s important to emphasize that FDA authorized the updated vaccine boosters even though those formulations have not been tested in humans with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), stressing their confidence that the boosters are safe and will be effective.
Yet, some medical experts have urged both FDA and CDC to wait until the manufacturers have human clinical data on the booster shots’ efficacy to approve them, fearing that fervent promotion of the updated boosters may overpromise protection against symptomatic disease for young, healthy Americans.
However, unvaccinated Americans would still receive the original vaccine formula as their primary series, before becoming eligible for the updated booster.
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