HealthDay News — A 2-dose regimen of 10μg of BNT162b2 COVID-19 vaccine administered 21 days apart is safe and efficacious in children aged 5 to 11 years, according to a study published online November 9 in the New England Journal of Medicine.

Emmanuel B. Walter, MD, from the Duke Human Vaccine Institute in Durham, North Carolina, and colleagues presented results for a phase 1, dose-finding study and an ongoing phase 2 to 3 randomized trial involving 5- to 11-year-old children who received 2 doses of the BNT162b2 vaccine administered 21 days apart.

Forty-eight children received 10, 20, or 30μg of the BNT162b2 vaccine during the phase 1 study. A dose level of 10 μg was selected on the basis of reactogenicity and immunogenicity. A total of 2268 children were randomly assigned to BNT162b2 and placebo in the phase 2 to 3 trial (1517 and 751, respectively). The researchers found that the median follow-up was 2.3 months at data cutoff. As in other age groups, the BNT162b2 had a favorable safety profile in the 5- to 11-year-olds, with no vaccine-related serious adverse events reported. The geometric mean ratio of severe acute respiratory syndrome coronavirus 2 neutralizing titers was 1.04 (95% CI, 0.93 to 1.18) for 5- to 11-year-olds vs 16- to 25-year-olds at one month after the second dose, meeting the prespecified immunogenicity success criterion (geometric mean ratio point estimate, 0.8 or greater). COVID-19 with onset 7 or more days after the second dose was reported in 3 and 16 recipients of BNT162b2 and placebo, respectively (vaccine efficacy, 90.7%).

“The data reported herein support vaccination of 5-to-11-year-old children with two 10-μg doses of the BNT162b2 vaccine,” the authors write.

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Several authors disclosed financial ties to biopharmaceutical companies, including Pfizer and BioNTech, which funded the study.

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