Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

  • By IPP Bureau | February 25, 2023

Pfizer and BioNTech SE announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older.

The original BLA for COMIRNATY as the primary series was approved in August 2021 for ages 16 years and older and later extended through an sBLA to include ages 12 through 15 years of age. Currently, the bivalent vaccine is available in the U.S. under Emergency Use Authorization (EUA) as a single booster dose for ages 5 years and older and as the third dose in the three-dose primary series for children 6 months through 4 years of age. As EUA is not meant to be a long-term status, this sBLA is the next step toward full regulatory approval of the bivalent vaccine.

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

In the European Union (EU), the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was granted full marketing authorization (MA) for administration as a booster dose in individuals 5 years of age and older who have completed a primary vaccination course against COVID-19. The companies also plan to submit applications to the European Medicines Agency (EMA) for a variation of the MA to also include the bivalent vaccine as a primary course of vaccination in individuals 5 years of age and older and a line extension for the bivalent vaccine as a primary course of vaccination and booster for individuals 6 months of age through 4 years.

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