Abstract of the COVID-19 vaccine in Children

- Objective: The COVID-19 still the pandamic that continues to ravage the
world. From children to the elderly can be infected with this dangerous
virus. The purpose of this study was to determine the effectiveeness of
BNT162b2, was funded by BioNTech and Pfizer, known as the COVID-19
vaccine to the children.

- Methods: The resercher conducted a phase 1 dose-finding study and

ongoing phase 2-3 safety, efficacy trial of the BNT162b2 vaccine in healthy
children from 6 months to 11 years of age. The present of the results for
children from 6 months to less than 2 years of age. In the phase 2–3 trial,
participants were randomly assigned (in a 2:1 ratio) to receive two 3-μg
doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity
results, a third 3-μg dose (≥8 weeks after dose 2) was administered starting
in January 2022, which coincided with the emergence of the B.1.1.529
(omicron) variant. Immune responses at 1 month after doses 2 and 3 in
children 6 months to less than 2 years of age and those 2 to 4 years of age
were immunologically bridged to responses after dose 2 in persons 16 to 25
years of age who received 30 μg of BNT162b2 in the pivotal trial.

- Results: During the phase 1 dose-finding study, two doses of BNT162b2

were administered 21 days apart to 16 children 6 months to less than 2 years
of age (3-μg dose) and 48 children 2 to 4 years of age (3-μg or 10-μg dose).
The 3-μg dose level was selected for the phase 2–3 trial; 1178 children 6
months to less than 2 years of age and 1835 children 2 to 4 years of age
received BNT162b2, and 598 and 915, respectively, received placebo.
Immunobridging success criteria for the geometric mean ratio and
seroresponse at 1 month after dose 3 were met in both age groups.
BNT162b2 reactogenicity events were mostly mild to moderate, with no
grade 4 events. Low, similar incidences of fever were reported after receipt
of BNT162b2 (7% among children 6 months to <2 years of age and 5%
among those 2 to 4 years of age) and placebo (6 to 7% among children 6
months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The
observed overall vaccine efficacy against symptomatic Covid-19 in children
6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to
87.6) from 7 days after dose 3 (on the basis of 34 cases).
- Conclusions: A three-dose primary series of 3-μg BNT162b2 was safe,
immunogenic, and efficacious in children 6 months to 4 years of age.