after reviewing the results of a Phase I, II, and III clinical trial of Pfizer’s BNT vaccine in children aged 6 months to 4 years, the test results showed that the experimental group of children aged 6 months to 4 years old was induced. The immunogenicity results of neutralizing antibodies were non-inferior to those of the adolescent and adult trial groups; in terms of safety, compared with other age groups, there were no new safety concerns.
The Food and Drug Administration stated that phone database considering the urgent public health needs of the country, the experts at the meeting suggested that the project should approve the Pfizer BNT vaccine for children aged 6 months to 4 years. micrograms of mRNA), the first 2 doses should be administered at least 21 days apart, and the third dose should be administered at least 8 weeks after the second dose.
In clinical trials, the most common adverse reactions reported by children aged 6 months to under 2 years who received any dose of the vaccine included agitation, decreased appetite, injection site tenderness, injection site redness, fever and injection site swelling, the FDA said. The most common adverse reactions in children aged 2 to 4 include injection site pain, fatigue, injection site redness, fever and headache. No cases of myocarditis, pericarditis or death were found in clinical trials.