COVID-19 vaccine by Pfizer and its German partner, BioNTech, was effective and safe for use in children aged 6 months to 4 years, reports said citing the U.S. Food and Drug Administration staff reviewers.
FDA staff stated that the available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years.
The agency’s staff said that their evaluation did not reveal any new safety concerns related to the use of the Pfizer-BioNTech vaccine in young children.
Pfizer and BioNTech completed their application to the FDA recently, seeking emergency use authorization of their Covid-19 vaccine for children ages 6 months to 5 years.
The companies said that data from a phase 2/3 trial of the vaccine included 1,678 children who received the third dose during the Omicron wave. The trial results, which were released on May 23, revealed that the vaccine was safe and had a strong immune response among the children.
The latest FDA analysis of data from Pfizer’s vaccine trial was published ahead of an upcoming key meeting of external advisers, whose recommendations will determine the agency’s vaccine decisions.
The FDA advisers are meeting for two days starting Tuesday to discuss mRNA vaccines in children. As per the reports, Pfizer’s application for vaccine clearance in young children will be discussed on June 15.
The vaccine approval application of another vaccine maker Moderna for children aged 6 months through 5 years will also be considered simultaneously. Last week, the FDA had said that Moderna’s vaccine is effective in children under 6 in preventing symptomatic infection without causing worrisome side effects. Moderna submitted its vaccine data for children 6 months through 5 years to the FDA in late April.
Children younger than 5 years are the only age group who are not eligible for vaccination against Covid-19 in the U.S.
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