Strike Two: US FDA Vaccine Advisors Again Shoot Down Broad COVID-19 Vaccine Boosting
Surprising move to have VRBPAC debate offering mRNA boosters to everyone 18 and up, less than one month after the panel shot that down for Pfizer’s vaccine, thus stalling the White House’s plan for a broad booster rollout, was driven internally by the FDA, a senior health official said.
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Emergency use authorization for Pfizer/BioNTech, Moderna vaccine boosters for everyone ≥18 years was based on the same immune response data that supported previous clearance in certain high-risk groups, although FDA said it also considered additional real-world data on myocarditis risk and the recent increase in COVID-19 cases.
With an EUA submission for its Paxlovid treatment pill and expected authorization for universal adult vaccine boosters, Pfizer is establishing a portfolio of COVID products that could be used well after the eventual lifting of the public health emergency.
After US FDA authorization for additional COVID vaccine shots, the focus now shifts to CDC’s advisory committee, which may be concerned about variations in eligible populations, timing and dosing when it comes to giving a booster different from the primary vaccination series.