CDC Panel Okays Use Of Omicron Bivalent COVID-19 Vaccines Despite Lack Of Clinical Data
One member says the vote was premature, but others conclude extrapolation of clinical data from another vaccine was sufficient given similar experience with flu vaccines and the potential to save thousands of lives.
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CDC advisory panel members voice concerns about mix-ups in the administration of COVID-19 vaccines. Pfizer’s bivalent and monovalent vaccines have the same gray cap while Moderna has different colored caps for its two versions.
The European Commission will shortly issue marketing authorizations for bivalent versions of Comirnaty and Spikevax targeting the Omicron BA.1 subvariant, after the European Medicines Agency recommended their approval for EU-wide use. Bivalent Spikevax has also been provisionally approved in Australia.
Pfizer/BioNtech’s and Moderna’s updated bivalent Omicron booster doses will be available in coming days. Pfizer/BioNtech has an ongoing study in individuals 12 and older and are preparing EUA application for those 6 months and older. Moderna completed enrollment of 512 participants in a Phase 2/3 trial.