Review of Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age—Walter 2021

"This is a brief audio review. In the article Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age published, 2022 by Walter and Colleagues, The outcomes and key points are as noted: BACKGROUND: Children younger than 12 require safe, effective vaccinations against Covid-19. METHODS: A phase 1, dose-finding research and an ongoing phase 2-3 randomized trial are investigating the safety, immunogenicity, and efficacy of two BNT162b2 vaccination doses provided 21 days apart in children 6 months to 11 years old. 5-to-11-year-olds are analyzed. In phase 2-3, subjects were randomly randomized in a 2:1 ratio to receive two doses of BNT162b2 vaccination at the dose level determined in phase 1 or placebo. Immune responses 1 month after the second BNT162b2 dosage were immunologically comparable to those in 16-to-25-year-olds from the pivotal study. After 7 days after the second dosage, Covid-19 vaccine effectiveness was evaluated.
48 children aged 5 to 11 got 10 grams, 20 grams, or 30 grams of the BNT162b2 vaccination in phase 1. (16 children at each dose level). Based on reactogenicity and immunogenicity, 10 g was studied. In the phase 2-3 trial, 2268 children received the BNT162b2 vaccination (1517) or placebo (751 children). Median follow-up was 2.3 months at data cutoff. The BNT162b2 vaccination demonstrated a good safety profile in 5-to-11-year-olds. There were no significant vaccine-related adverse effects. One month after the second dose, the geometric mean ratio of SARS-CoV-2 neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), meeting the pre-specified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, 0.8). Three BNT162b2 vaccine users and 16 placebo recipients reported Covid-19 7 days after the second dose (vaccine efficacy, 90.7 percent ; 95 percent CI, 67.7 to 98.3).
Two 10-gram doses of BNT162b2 administered 21 days apart were safe, immunogenic, and effective in 5 to 11-year-olds. (BioNTech and Pfizer funded; NCT04816643)."