Following a routine review by the external independent Data Monitoring Committee (DMC), Pfizer and BioNTech said they will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to under 5 years of age. The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series.
If the three-dose study is successful, the companies said they plan to submit data to regulators to support an emergency use authorization (EUA) in the first half of 2022 for children 6 months to under 5 years of age.
They said that while the study is “ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which 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 in this analysis. “
Pfizer and BioNTech said they also plan to evaluate a third dose of the 10-µg formulation in children 5 to under 12 years of age. The companies have initiated a low dose sub-study of a third dose of 10 µg or 30 µg in approximately 600 adolescents aged 12- to 17.