Following FDA, CHMP gives thumbs-up on Pfizer, BioNTech Omicron booster
One day after the FDA cleared Pfizer’s bivalent booster to go after Omicron, the pharma giant and its partners at BioNTech are now one step closer to an EU authorization.
Pfizer and BioNTech jointly announced Thursday that the EMA’s CHMP committee recommended conditional marketing authorization for the pair’s Comirnaty bivalent booster for Omicron to the European Commission. The bivalent booster, which would be approved in people ages 12 and up, targets both the wild-type SARS-CoV-2 virus and the Omicron subvariant BA.1.
While the official approval lies with the European Commission, the entity usually follows CHMP recommendations. The biotech and Big Pharma combo noted that they expect a final decision from the Commission “soon.”
This is the newest update to a several-month saga to get a vaccine approved for Omicron. Just yesterday, the FDA granted authorization to both Pfizer and Moderna’s bivalent boosters as both of the Covid-19 mRNA juggernauts have been pushing to get the newest vaccine past regulators.
Pfizer and BioNTech noted that CHMP based its recommendation on a Phase II/III trial in older adults, who were all a minimum of 56 years old. That study reported that the booster, tested in 178 patients, showed a higher immune response against BA.1 compared to the original vaccine.
As for what’s next, the two companies said if the European Commission signs off on the authorization, the booster would be available in Europe within a matter of days to all 27 EU member states. Beyond that, another EMA application is pending for Pfizer and BioNTech for a BA.4 and BA.5 bivalent vaccine.
Pfizer declined to comment, and Endpoints News did not hear back from BioNTech in time for publication.
This gives Pfizer a leg up against Moderna, which got one of its Omicron boosters greenlit in Switzerland earlier this week. Moderna has been working on two boosters for approval in different markets — one for BA.1 and another for BA.4 and BA.5.