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Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster.
Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters.
Last week, the UK approved Moderna’s bivalent COVID-19 vaccine based on the original omicron lineage BA.1.
Pfizer and BioNTech are seeking authorization for a booster vaccine targeting the more recent sublineages omicron BA.4/BA.5.
If granted, the booster would be available for individuals at least 12 years old.
Pfizer and BioNTech note that the vaccine, if authorized, is available for immediate shipment.
The companies note that they plan on beginning a clinical trial focused on the omicron BA.4/BA.5-adapted bivalent vaccine candidate. The vaccine will analyze the vaccine’s safety, tolerability and immunogenicity.
The study would involve individuals 12 years of age and older.
FDA has signaled that it knows enough about the mRNA-based vaccines from Moderna, Pfizer and its partner BioNTech to authorize updated BA.4/BA.5-adapted boosters without new clinical trial data.
In June, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended updated COVID-19 vaccine boosters for the fall and winter months.
Pfizer and BioNTech have already studied their omicron BA.1-adapted bivalent vaccine in a Phase 2/3 study. Data from that study indicated that the updated booster generated a more robust immune response against the omicron BA.1 variant than the original BNT162b5 vaccine.
The Biden administration has signaled its intent to administer updated COVID-19 boosters in September.
After that, the administration will likely turn the bulk of responsibility for the COVID-19 response to the private sector.
PFE shares were mostly flat in mid-day trading, edging down 0.12% to $49.10.
Conversely, BNTZ shares were up about 1% to $149.35.
The BNT162b5 vaccine is already one of the bestselling pharmaceutical products in history. Last year, the vaccine generated $59.1 billion in total revenue between Pfizer and BioNTech.