Pfizer/BioNTech seek U.S. emergency nod for updated COVID booster in kids

Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announced Wednesday the companies filed an application to the FDA seeking Emergency Use Authorization (EUA) for their Omicron-adjusted COVID vaccine as a booster shot for children under five years.

Currently, the vaccine adjusted for Omicron BA.4/BA.5 subvariants is authorized as the third dose of a three-dose primary vaccine regimen for the age group.

“Authorization of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sublineages,” Pfizer (PFE) and BioNTech (BNTX) said.

If the FDA clears the EUA bid, U.S. children aged six months - 4 years will be able to receive the mRNA-based shot as a 3-µg booster dose at least two months from completion of the primary vaccine series.

The companies expect to submit a regulatory filing in the EU for marketing authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine to include children aged six months – 4 years for both primary series and booster (fourth dose) vaccination.

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