Pfizer Submits for COVID-19 Vaccine Data for Children
The pharmaceutical company has filed information from a study involving over 2,000 children; it has not yet requested emergency use authorization but plans to do so in the coming weeks.
-
US Food and Drug Administration (FDA) is expected to examine the data for at least a few weeks
Pfizer announced on Tuesday that it had submitted preliminary trial data on vaccinating children aged 5 to 11 against the coronavirus to US regulators.
The pharma giant stated that it has not yet sought emergency use authorization for the Pfizer-BioNTech vaccine, but that it may do so in the coming weeks.
The company intends to submit to the European Medicines Agency (EMA) and other regulatory bodies.
Meanwhile, the US Food and Drug Administration (FDA) is expected to examine the data for at least a few weeks before granting emergency use authorization.
Pfizer said it studied a vaccine with a much lower dose — a third of what is currently in each shot — in 2,268 kindergartners and elementary school-aged children.
Furthermore, the company announced last week that its vaccine is effective for that age group and that after receiving their second dose during testing, children aged 5 to 11 developed coronavirus-fighting antibody levels comparable to teenagers and young adults receiving regular-strength shots.
