According to FDA, The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age. Two outstanding, randomly selected, blinded, placebo-controlled clinical trials in the United States and Canada that included infants, children, and adolescents produced the effectiveness and safety data that the FDA evaluated and analyzed for the Moderna COVID-19 Vaccine to support the EUA for these pediatric populations. Derived on a correlation of immunogenicity following three doses of the Pfizer-BioNTech COVID-19 Vaccine in a subset of children in this age group to immune function among adults 16 through 25 years of age who received at least higher doses of the Pfizer-BioNTech COVID-19 Vaccine in a prior study that found the vaccine to be effective in preventing COVID-19, the effectiveness data to support the EUA in children 6 months through 4 years of age. Two age categories were studied in the study. Eighty toddlers aged between six and twenty-three months and 140 children aged between two and four years each had their immune reactions to the immunization compared to 170 of the participants who were older.
Most frequently reported side effects on clinical trial participants aged 6 to 23 months who received the vaccination:
- decreased appetite
- Swelling at the injection site
According to these FDA evaluations, both age groups of children’s immunological reactions to the vaccine were on par with those of the participants who were older. Due to the small number of COVID-19 instances that affected study participants, a second analysis regarding their occurrence was found to be unreliable. About 1,170 children aged 6 to 23 months who got the vaccine and about 600 who received a placebo were included in the safety data to support the EUA; 400 vaccine recipients were monitored for safety for at least two months after receiving the third dose. A total of 1,800 participants aged 2 to 4 years received the vaccination, 900 received a placebo, and 600 vaccine recipients were monitored for safety for at least two months after receiving the third dose.