COVID-19 mRNA Vaccine Trials in School-Aged Children
November 22, 2021
COVID-19 mRNA Vaccine Trials in School-Aged Children
Deborah Lehman, MD, reviewing
Two 10-µg doses of BNT162b2 (Pfizer-BioNTech) vaccine 21 days apart were safe and effective in children aged 5 to 11 years.
Children younger than 18 years account for an increasing proportion of COVID-19 cases in the U.S., where >700 children have died. opens in new tab since the pandemic began. COVID-19 vaccines received emergency use authorization for children aged >12 years in May 2021.
Manufacturer-supported studies of the BNT162b2 (Pfizer-BioNTech) vaccine were conducted in children aged 5–11 years to determine an appropriate dose (10 µg, 20 µg, or 30 µg) as well as its safety, immunogenicity, and efficacy. Results include the following:
- Most reactions were local (pain at injection site), transient, and most often reported following the 30-µg dose.
- Serum neutralizing geometric mean titers (GMT) 1 week after the second dose were high (4163 and 4583 for 10 µg and 20 µg, respectively), supporting the use of a 10-µg regimen.
- Serum neutralizing GMTs 1 month after receipt of the second 10-µg dose were similar in 5- to 11-year-old children as in with those aged 16 to 25 years who received the 30-µg series.
- Three children in the vaccine group tested positive for SARS-CoV-2 compared with 16 in the placebo group, for an efficacy of 90.7%.
CITATION(S):
Walter EB et al. Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. N Engl J Med 2021 Nov 9; [e-pub]. (https://doi.org/10.1056/NEJMoa2116298. opens in new tab)
COMMENT
The BNT162b2 mRNA vaccine performed well in this younger age group. As the pandemic continues, children remain at risk for severe disease requiring hospitalization, multisystem inflammatory syndrome, and even death. Vaccinating younger children provides hope that the significant impact this pandemic has had on all children may begin to diminish.