FDA staff says Pfizer vaccine effective, safe for young children, final review set for Wednesday

Food and Drug Administration staff reviewers said Sunday that Pfizer-BioNTech's COVID-19 vaccines were effective and safe for children ages 6 months to 4 years.

The reviewers announced their evaluation in briefing documents that did not state any new safety concerns related to the use of the vaccine in young children, according to Reuters.

The FDA's analysis of data from the pharmaceutical firms' trial was published ahead of a meeting Wednesday of its outside advisers, whose recommendation will be the final consideration for the agency on the vaccines.

An early analysis of data from the firms' vaccine based on symptomatic COVID cases when the Omicron coronavirus variant was dominant suggested an efficacy of 80.3% in children under 5, the wire service also reports.