BackPfizer and BioNTech file application for shot against latest Omicron strains
Pfizer and partner BioNTech said they had completed a submission to the US FDA for authorisation of a Covid vaccine adapted to target the Omicron variant
PremiumPfizer and partner BioNTech on Monday asked US Food and Drug Administration (FDA) for "emergency use" authorisation of its Omicron-specific mRNA injection.
The request was for a so-called bivalent vaccine that contains the dominant BA.4/BA.5 variants of the virus, along with the original Covid-19 strain.
In a statement, the firms said they had “rapidly scaled production" for the new booster and would be able to ship doses of the bivalent vaccine “immediately" upon emergency authorization. The new bivalent vaccine contains mRNA encoding the original Covid spike protein, as well as mRNA for the spike protein of the BA.4/BA.5 subvariants, which are currently dominant.
A conditional marketing authorization application has also been initiated in Europe, the companies said. The shot is intended for use in individuals 12 and older, Pfizer stated.
The US FDA had in June asked Covid vaccine makers to tailor shots to target the two subvariants.
The American government has since signed a deal with both Moderna and Pfizer for delivery of Omicron-adapted vaccines, pending clearance.
If the FDA quickly clears the combo shots made by Pfizer and its partner BioNTech, boosters could be offered within weeks.
The US has a contract to buy 105 million of the updated Pfizer doses as soon as health authorities greenlight them, and the company said doses are ready to ship.
Moderna will likely file a similar application soon, and the US has a contract to buy 66 million doses of its updated vaccine.
“It’s going to be really important that people this fall and winter get the new shots. It’s designed for the virus that’s out there," White House COVID-19 coordinator Dr Ashish Jha said last week.
For now at least. BA.5 currently is causing nearly all Covid infections in the US, and much of the world. There’s no way to know if it still will be a threat this winter -- or if another mutant will have replaced it.
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