Pfizer to Ask FDA to Authorize Covid-19 Vaccine for Children Under 5

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“Sadly, we are seeing the rates of hospitalizations increasing for children 0 to 4, children who are not yet currently eligible for Covid-19 vaccination,” Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, told reporters this month. She said the high rate of transmission of the Omicron variant was likely to blame.

The F.D.A. and C.D.C. are both expected to convene committees of outside vaccine advisers before a decision on whether to clear the shots. That will give independent experts a chance to discuss the data the companies have gathered. Most senior federal health officials are strongly behind the strategy, two officials said, but they want the outside experts to weigh in.

Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek F.D.A. clearance for three doses for young children, a strategy that she said would allow for “a consistent three-dose vaccine approach for all ages.” The company switched its plan because the F.D.A. was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.

The C.D.C. now considers three doses of the vaccine to be an “up-to-date” regimen for those eligible for extra shots, including those 12 and up. Regulators have authorized booster doses given five months after second injections. Children as young as 5 who have weakened immune systems are also eligible for extra shots.

The deliberations in the coming weeks could affect how quickly parents get their youngest children vaccinated. The pace of vaccination for America’s 28 million children between 5 and 11 remains even lower than health experts had feared. Roughly 30 percent of children in that age group have received at least one dose, according to C.D.C. data.

The reasons more young children have not gotten shots vary. Some parents are put off by misinformation about the vaccine; others do not believe the virus is enough of a threat to vaccinate their children. Some simply have not yet found the time to take their children in for shots, health officials report.

The C.D.C. released research in late December that showed very few reports of serious problems among children 5 to 11 who had received Pfizer-BioNTech shots. Another study of hundreds of pediatric hospitalizations in six cities last summer, released by the agency, found that nearly all of the children who became seriously ill had not been fully vaccinated.



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