Staff reviewers of the American Food and Drug Administration stated on Sunday that Pfizer-BioNTech’s COVID-19 vaccines were safe and effective for children between the ages of 6 months to 4 years. Moreover, the FDA reviewers said the same in the briefing documents published on Sunday evening. Their evaluation did not reveal any new safety issues concerning the use of the vaccine in young children.
The FDA analysis of data from Pfizer’s vaccine trial was published ahead of a June 15 meeting. Recommendations from these external advisers will determine the FDA’s decision on the vaccines. The FDA staff said:
Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years.
Details of analysis by FDA
An early analysis of data by the FDA from Pfizer-BioNTech’s vaccine was based on 10 symptomatic COVID-19 cases. They were identified when the Omicron coronavirus variant was dominant. The analysis suggested a vaccine efficacy of 80.3% in the under-5 age group. COVID-19 vaccines for children under the age of 6 years are not yet approved in most countries. This is because of the low demand for vaccines for kids aged 5 to 11 years, as informed by FDA. It is also not known how many parents would get their young ones vaccinated.
