Study Assessing Pfizer-BioNTech COVID-19 Vaccine in Children Aged 6 Months to Under 5 Years Will Continue, Assess a Third Dose

Investigators in a clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to under 5 years noted that their research will continue with new changes.

Based on the trial results, investigators in the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to under 5 years explained that their research will continue with new changes. According to a press release, the study will now include an evaluation of a third dose of 3 µg at least 2 months after the second dose of the 2-dose series to provide high levels of protection in the younger age groups.

A pre-specified immunogenicity analysis was conducted on the subset of the study population 1 month following the second dose. In comparison to the 16- to 25-year-old population, where high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population, but not for the 2- to under-5-year-old population. Additionally, no safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.

If successful, the new evaluation will lead to Pfizer and BioNTech submitting data to regulators to support an emergency use authorization for children 6 months to under 5 years of age in the first half of 2022. The companies also plan to analyze a third dose of the 10 µg formulation in children 5 to under 12 years of age, according to the press release.

Both Pfizer and BioNTech have started a low dose sub-study of a third dose of 10 µg or 30 µg in approximately 600 adolescents between 12 and 17 years of age to assess safety and immunogenicity. The phase 1, 2, and 3 trial enrolled up to 4500 children between the ages of 6 months and under 12 in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. These trials were designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a 2-dose schedule in 3 age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.

REFERENCE

Pfizer and BioNtech provide update on ongoing studies of COVID-19 vaccine. Pfizer. December 17, 2021. Accessed December 17, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19