COVID-19 Vaccine Boosters Targeting Omicron BA.4/BA.5 To Launch As Clinical Trials Continue
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.
You may also be interested in...
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.
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.
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’