FDA Grants Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine in Children Aged 6 Months to 4 Years

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News on June 20, 2022 /BioValleyBIOON/ -- Pfizer and BioNTech recently announced jointly that the U.S. Food and DrugManagementBureau (FDA) has granted its COVID-19 vaccine (Pfizer-BioNTechCOVID-19Vaccine) Emergency Use Authorization (EUA): Three doses of 3µgImmunityVaccination regimen for ages 6 months to 4 years (also referred to as 6 months to under 5 years)ChildrenBased on safety, tolerability, and immunogenicity data, the 3μg dose was cautiously selected as the preferred dose for children under 5 years of age.

According to this EUA, the Pfizer/BioNTech COVID-19 vaccine is now authorized for use in all individuals aged 6 months and above. In clinical trials, the three-dose series of 3µg Pfizer-BioNTech COVID-19 Vaccine elicited a robust immune response in the age group of 6 months to 4 years and demonstrated a favorable safety profile comparable to placebo.

This EUA is based on data from a Phase 2/3 randomized controlled trial that included 4,526 children aged 6 months to 4 years. In the trial, children received a third dose of the 3µg formulation at least two months after their second dose of the 3µg formulation, during a period when Omicron was the predominant variant. The results showed that a strong immune response was elicited after the third dose in this age group, with a favorable safety profile comparable to placebo.

In the trial, one month after the third dose, the geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibodies in children aged 2 to 4 years was 1535.2 (95% CI: 1388.2, 1697.8), and in infants aged 6 months to 23 months, it was 1406.5 (95% CI: 1211.3, 1633.1). The antibody responses in these two age groups were comparable to those recorded in individuals aged 16 to 25 years who received two doses of the 30µg vaccine and met the predefined non-inferiority success criteria. The confirmation of non-inferiority and safety is a regulatory requirement for the potential authorization of the Pfizer-BioNTech COVID-19 Vaccine in this age group.

Three doses of 3µg vaccine demonstrated a favorable safety and tolerability profile comparable to placebo, with no new safety signals identified. The incidence of adverse reactions in children aged 6 months to 4 years was generally lower than in children aged 5 to 11 years. In the 6 to 23 months age group, 30.3% of children in the vaccine group reported adverse events, compared to 27.3% in the placebo group. In the 2 to 4 years age group, 18.8% of children in the vaccine group reported adverse events, compared to 18.9% in the placebo group. Reactogenicity events in both age groups were mostly mild to moderate in severity, of short duration, and systemic events were comparable to placebo. Reactogenicity following doses 1, 2, and 3 was comparable.

Pfizer Chairman and CEO Albert Bourla said, "Tens of millions of older children around the world have already been vaccinated with our COVID-19 vaccine, helpingPreventionSymptoms, severe illness, and hospitalization. We know that many parents in the United States have been eagerly waiting to vaccinate their children under 5 years old with an authorized vaccine, and now we are proud to offer them a vaccine option with good safety." (Bioon.com)

Source of the original text:Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age