Pfizer submits data to FDA on COVID vaccine in young kids
Pfizer and BioNTechsubmitted initial datafrom a phase 2/3 trial of their mRNA COVID-19 vaccine for children ages 5 to 11 years to the Food and Drug Administration (FDA), and said an application for emergency use authorization of the vaccine in that age-group will likely follow in the coming weeks.
On Sep 20, the company shared promising results in children in that age range of two doses of the mRNA vaccine, which contains 10 micrograms (μg) of active ingredient, compared with 30 μg contained in the currently FDA-approved vaccine. Pfizer said the company will have data on vaccines in children ages 6 months to 2 years, and 2 years to 5 years, as soon as the fourth quarter of 2021.
Children under age 5 received a lower 3-μg dose for each injection in the phase 2/3 study, the company said.
Children 11 and younger are the only group of Americans not yet eligible for COVID-19 vaccination, and pediatric cases of the virus have increased significantly since the Delta (B1617.2) variant became the dominant strain in the United States this summer.