Pfizer/BioNTech’s Omicron Booster Snags Another FDA Emergency Use Authorization

The United States Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for Pfizer’s Omicron BA.4/BA.5 bivalent COVID-19 vaccine use in children 5 through 11 years of age. Previously, the new vaccine boosters received a EUA for use as a booster in older age ranges at the end of August. 

The new EUA comes as new COVID cases continue trending downward, nearing an all-time low for this year. 

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Expanding Omicron Booster Protection to Young Children

The FDA granted Pfizer/BioNTech’s updated COVID-19 vaccine a EUA at the end of August while simultaneously doing the same for Moderna’s own vaccine. Protecting against Omicron strains BA.4/BA.5, the most prevalent variants at the time, the FDA approved the shot as a booster for prior vaccinations. 

Patients eligible for the bivalent update were those aged twelve and older two months after completing a primary vaccination course or receiving the prior booster dose. 

Seeking the expansion of those eligible, Pfizer/BioNTech submitted a request for this EUA based on safety and immunogenicity from their bivalent Omicron BA.1. In addition, the companies initiated a Phase 1/2/3 pediatric study evaluating the safety, tolerability, and immunogenicity across various age ranges. These include participants 6 months through 23 months without previous coronavirus vaccination, participants 6 months through 4 years who have either received two or three prior doses, participants 6 months through 4 years who have received three prior doses, and participants 5 through 12 years who have received two or three prior doses.

On October 12, the FDA approved the EUA. On the decision, Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “This milestone is important to be able to provide access to variant-adapted vaccines to a broader population.”

Anticipating the approval, Pfizer/BioNTech manufactured “millions of booster doses,” which are ready for shipment as per existing agreements pending recommendation from the Centers for Disease Control and Prevention (CDC).

This most recent EUA comes at a time when COVID-19 cases already decline. According to the CDC, from August 31, the day the bivalent vaccines received their initial EUA, the seven-day moving average fell from 87,655 to 39,893 on October 11. This is already a reduction from the most recent peak of 129,717 on July 16. 

Author

Max Heirich