In a briefing document released Sunday, the Food and Drug Administration (FDA) deemed Pfizer and BioNTech’s COVID-19 vaccine safe and effective for use in the only age group not yet eligible for vaccination in the US – children under 5.
FDA’s review also shows that despite the babies, toddlers, and preschoolers only making up about 3% of cases in the US, Covid hospitalizations and deaths for children 6 months to 4 years old are higher than for children in other age groups.
According to the documents cited by the agency, the vaccine has proved effective in preventing symptomatic COVID-19 for 75.6% of children ages six to 23 months old and 82.4% for children between ages 2 and 4.
The overall, combined effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series (3 µg each dose) in both groups, as the FDA said, was 80.4 percent.
The analysis of the vaccine’s safety among the over 3,000 vaccine recipients also showed no safety concerns compared with the safety profile described in older age groups.
The agency posted a similar analysis last week showing Moderna’s COVID-19 vaccine is both effective and safe for children under the age of 6 though the effectiveness percentage at preventing milder infections, in this case, was only about 40% to 50%.
The review has been published ahead of the scheduled Wednesday meeting in which FDA’s outside independent experts will consider granting an emergency use authorization (EUA) vote if both jabs are ready for the nation’s youngest population.
Although FDA is not required to follow the advisory committee’s recommendation, it usually does so this could quickly pave the way for widespread availability of the vaccines which could be available as early as next week should the FDA and the Centers for Disease Control and Prevention (CDC) sign off on the shots for younger children.
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