Pfizer seeks U.S. approval for a reformulated Omicron vaccination booster

Pfizer Inc (NYSE:PFE) and its German partner BioNTech stated on Monday that they had submitted an application for U.S. approval of a COVID-19 vaccine booster modified to target the Omicron form and that doses would be available for distribution immediately following regulatory clearance.

The request to the Food and Drug Administration was for a bivalent vaccine containing both the widespread BA.4/BA.5 variants and the original coronavirus strain. It is intended for persons older than 12 years.

Pfizer indicated that it was set to fulfill a $3.2 billion contract with the United States government for 105 million doses, including Omicron-tailored injections, in September.

Albert Bourla, the chief executive officer of Pfizer, said in a statement, "We are prepared to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters if approved."

Countries, including the United Kingdom, the United States, and members of the European Union, have prepared fall vaccination campaigns to protect against future outbreaks. The United Kingdom was the first nation to approve a bivalent immunization developed by Moderna last week (NASDAQ:MRNA).

Bourla announced on Twitter that Pfizer plans to finalize its submission to the European Medicines Agency in the next few days (NYSE:TWTR).

Similar to how annual changes to influenza vaccinations are handled, the FDA requested in June that COVID-19 vaccine producers modify injections to target the two sub variants and noted that it would not require new human testing studies for approval.

According to mid- to late-stage studies, Pfizer's older BA.1-tailored vaccine demonstrated a superior immune response against the subvariant.

This month, it is anticipated that a study of the BA.4/BA.5 vaccine in adults aged 12 and older would commence.