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Food and Drug Administration scientists found the Pfizer-BioNTech COVID-19 vaccine is safe and effective for children younger than 5, according to a review published Sunday.
Why it matters: The FDA scientists' briefing document comes ahead of Wednesday's scheduled meeting of the agency's independent experts, when they will consider Pfizer and BioNTech's request for emergency use authorization of the vaccine for young children.
- FDA scientists also found Moderna to be safe and effective for young children and infants, and the independent experts will consider a request for it to be used in children younger than 6.
- Young children remain the only people in the U.S. ineligible to receive a coronavirus vaccine.
What they found: Preliminary data shows the Pfizer-BioNTech vaccine is 75.6% percent effective in preventing symptomatic COVID-19 for babies and toddlers in 6-23 months age group, 82.4% effective in 2- to 4-year-old children and 80.4% effective in a combined analysis of both groups, according to the briefing document.
What they're saying: "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," the FDA scientists say in their analysis, noting that it's too soon to reach "definitive conclusions."
The bottom line: The "available safety data from a total database of over 3,000 vaccine recipients do not suggest any new safety concerns compared with the safety profile described in older age groups," according to the briefing document.