F.D.A. to meet Feb. 15 to consider approving Pfizer vaccine for children 0-5 years old

Filed Under: Costs

syringe

Authorization of a Covid vaccine made by Pfizer-BioNTech for children younger than age 5 will be considered by he Food and Drug Administration at a meeting on Feb. 15, the F.D.A. reported.

Children 6 months to 4 years old would be affected by an F.D.A. decision. The Pfizer-BioNTech vaccine was authorized for children 5 through 11 in October 2021.

“As of Dec. 19, 2021, according the Centers for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to kids 5 through 11 years of age, which is about one-third of the approximately 24 million U.S. kids this age in the U.S.,” a press release said. “There are approximately 23 million children less than 5 years of age in the U.S.”

The standard procedure has been that the Centers for Disease Control will approve an F.D.A. recommendation for an “emergency use authorization,” which is the approval that is currently governing all Covid vaccines in the United States, a few days later. After that, the actual appointments can be scheduled by providers, and vaccination can be made. The F.D.A. has responsibility for approving products for market, while the C.D.C. has jurisdiction over public health.

It’s not clear how big the dose will be. The dose for children 5 to 11 is 10 micrograms, a third the amount recommended for older children and adults.

Many parents of younger children have been eagerly awaiting this approval. “In December, Pfizer extended its vaccine trial in younger children after two child-sized doses of the vaccine did not produce the expected immunity in 2- to 5-year-olds, although it did so for the babies up to age 2,” CNN reported. “The companies said data on a third dose given at least eight weeks after the second dose is expected in the coming months, which will also be submitted to the FDA.”