Pfizer asks FDA to authorize Covid-19 vaccine for children under 5

“Unfortunately, we are seeing an increase in hospitalization rates for children aged 0 to 4, children who are not currently eligible for Covid-19 vaccination,” said Drs. 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 probably to blame.

The FDA and CDC are both expected to convene committees of outside fax advisers for a decision on deleting the shots. This will give independent experts a chance to discuss the data the companies have collected. Most senior federal health officials are strongly behind the strategy, two officials said, but they want outside experts to venture out.

Kathrin Jansen, head of vaccine research at Pfizer, said in December that the company would seek FDA approval for three doses for young children, a strategy she said would allow “a consistent three-dose vaccine approach for all ages.” The company changed its plan because the FDA was pushing for more urgent action, two people said. As authorized, young children receive their second dose three weeks after the first, and a third dose two months thereafter.

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

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

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

The CDC published a study 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 hospitals in six cities last summer, released by the bureau, found that almost all children who became seriously ill were not fully vaccinated.

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