FDA Authorizes Pfizer COVID-19 Vaccine For Children Between 6 Months - 4 Yrs

(RTTNews) - The U.S. Food and Drug Administration granted emergency use authorization of Pfizer Inc. (PFE) and BioNTech SE's (BNTX) COVID-19 vaccine as a three 3-micrograms dose series for children 6 months through 4 years of age, the companies said in a statement on Friday.

The emergency use authorization was based on data from a phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age.

In the trial, children received the third 3-micrograms dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.

The companies noted that they will begin shipping 3-micrograms pediatric doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.

The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency in early July.

Pfizer-BioNTech COVID-19 vaccine now authorized in the U.S. for all individuals 6 months of age and older.