Pfizer, BioNTech Submit Positive Data From COVID-19 Vaccine Trial In 5 To <12 Years To FDA

COVID-19 vaccine makers Pfizer Inc. (PFE) and BioNTech SE (BNTX) Tuesday announced that they have submitted initial positive data to the U.S. Food and Drug Administration from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

The data have been shared with the FDA for the Agency's initial review. A formal submission to request Emergency Use Authorization or EUA of the companies' COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks. The companies also plan submissions to the European Medicines Agency and other regulatory authorities.

On September 20, the companies had announced positive topline results from the pivotal trial, which included 2,268 participants 5 to <12 years of age. The results are first from a pivotal trial of any COVID-19 vaccine in this age group.

In the trial, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 g doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 g doses.

The companies said the 10 g dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.

Further, the companies expect topline immunogenicity and safety readouts for the other two age cohorts from the trial - children 2 to <5 years of age and children 6 months to <2 years of age - as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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