Pfizer COVID vaccines are safe for young children, FDA staff say

U.S. Food and Drug Administration (FDA) staff reviewers said Sunday that Pfizer-BioNTech’s COVID vaccines are safe and effective for children ages 6 months to 4 years.

FDA reviewers said in briefing papers released late Sunday that their evaluation revealed no new safety issues related to the use of the vaccine in young children.

The FDA’s analysis of Pfizer’s trial data was released ahead of a June 15 meeting of its outside advisers. The recommendations of these external advisers will determine the FDA’s decision on the vaccines.

“Available data support the efficacy of the primary 3-dose series of the Pfizer-BioNTech COVID-19 vaccine in the prevention of COVID-19 in the age group 6 months to 4 years,” said the staff of the FDA in review.

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

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

(With agency contributions)

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Post expires at 10:44am on Thursday June 23rd, 2022