Pfizer COVID vaccines are safe for small children, says FDA staff

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years.

The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.

The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from these external advisers will determine the FDA's decision on the vaccines.

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"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," FDA staff said in the review.

An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.

COVID vaccines for children under the age of 6 are not yet approved in most countries. Due to low demand for vaccines in for kids aged 5 to 11, it is also not known how many parents would get their young ones vaccinated.

(With inputs from agencies)

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