Pfizer and BioNTech seek FDA nod for omicron-adapted booster

Pfizer and BioNTech have submitted a request to the FDA for Emergency Use Authorization of an omicron-adapted COVID-19 booster dose for individuals 12 years of age and older. Pending authorization, the omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.

The updated formula combines the original vaccine with one that targets BA.4 and BA.5 and would be administered as a 30 microgram dose.

The move comes after the FDA told manufacturers to focus updated vaccines on leading omicron subvariants BA.4 and BA.5. 

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement.

The companies previously announced data from a trial that showed their BA.1 bivalent booster resulted in a higher immune response against the Omicron variant. 

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