U.S. FDA expands authorization of Pfizer bivalent COVID-19 pictures in children

(Reuters) – Pfizer Inc (NYSE:) mentioned on Tuesday that the U.S. Meals and Drug Administration had expanded the emergency use authorization (EUA) of the corporate and its companion BioNTech SE (NASDAQ:)’s bivalent COVID-19 vaccine as a single booster dose in sure youngsters.

The amended authorization is for youngsters six months by means of 4 years of age who’ve accomplished their preliminary three-dose vaccination with Pfizer’s unique shot.

In December, the U.S. well being regulator had licensed Pfizer/BioNTech’s up to date shot as a 3rd dose to these aged six months by means of 4 years, who haven’t accomplished their major vaccination collection or are but to obtain the third dose.

The well being regulator’s amended authorization is predicated on knowledge from 60 youngsters, from the expanded age group, who accomplished major vaccination with three doses and obtained a booster shot of Pfizer/BioNTech, and confirmed an immune response to each the unique SARS-CoV-2 virus pressure and to Omicron BA.4/BA.5.

Photographs for youngest youngsters in the USA had been solely authorized in June final yr, making them the final group to grow to be eligible for vaccination.    Authorities knowledge exhibits that solely 2.7% youngsters beneath the age of two and fewer than 5% of youngsters aged two to 4 years who’re eligible have accomplished their major vaccination collection as of Nov. 30, representing a sluggish uptake of the preliminary vaccine doses in younger youngsters.