Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021

“…This report provides preliminary safety findings from VAERS and v-safe data collected during the administration of approximately 8 million doses of Pfizer-BioNTech COVID-19 vaccine to children aged 5-11 years. The findings summarized in this report are similar to the safety data from preauthorization trials for Pfizer-BioNTech COVID-19 vaccine administered to children aged 5-11 years (4,5). Trial participants who received Pfizer-BioNTech COVID-19 vaccine frequently reported local (86.2%) and systemic (66.6%) reactions that were mostly mild (i.e., did not interfere with normal daily activities) or moderate (some interference with normal daily activities); no serious adverse events judged to be related to vaccination were reported (3).…”

“…Approximately 42,504 children aged 5-11 years were enrolled in v-safe after vaccination with Pfizer-BioNTech COVID-19 vaccine; after dose 2, a total of 17,180 (57.5%) local and 12,223 systemic (40.9%) reactions (including injection-site pain, fatigue, or headache) were reported. The preliminary safety findings are similar to those from preauthorization clinical trials (4,5). The Advisory Committee on Immunization Practices (ACIP) recommends the Pfizer-BioNTech COVID-19 vaccine for children aged 5-11 years for the prevention of COVID-19 (6).…”

Covid-19 in Children and Adolescent: Characteristics and Specificities in Immunocompetent and Oncohematological Patients

“…After a median follow-up of 2.3 months from the second dose, the vaccine efficacy against documented COVID-19 was 90.7%; moreover, no vaccine-related serious adverse events were noted, and the serum antibody level of neutralizing antibodies against SARS-CoV-2 was comparable to that observed in a control group of subjects of 16-25 years vaccinated with the adult dose of 30 mg BNT162b2 vaccine. 140 Although mRNA vaccines' safety and tolerability profile is favorable, myocarditis has been reported as a rare complication, especially in adolescent or young adult males. A recent Israeli study 141 showed that the incidence of myocarditis, albeit low, was increased in 16-19-year-old males who received the BNT162b2 mRNA vaccine (8.62 events / 100,000).…”

Tom Nolan’s research reviews—19 November 2021

“…The phase II/III double-blind randomised controlled trial of Pfizer’s BNT162b2 vaccine in 5-11 year olds has been published in NEJM 1. It contains another classic covid incidence-versus-time graph, where the placebo arm ascends like an alpine pass and the BNT162b2 arm has the gentle ascent of a stroll in Norfolk.…”