A top F.D.A. official says very young children need protection from Covid.


A meeting of outside advisers to the Food and Drug Administration to consider coronavirus vaccines for young children kicked off Wednesday morning with a plea from Dr. Peter Marks, the agency’s top vaccine regulator, about the need to protect children 5 and younger from Covid-19.

“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here,” he told the panel.

The advisory panel voted later in the day to recommend emergency authorization of the pediatric vaccine developed by Moderna, and was considering doing the same for the one developed by Pfizer with its partner BioNTech. The F.D.A. and the Centers for Disease Control and Prevention are expected to act swiftly on the recommendations, potentially clearing the way for young children to begin receiving shots early next week.

Dr. Marks, who oversees the F.D.A’s vaccine division, said hundreds of children had died of Covid in the United States, a rate that he said “compares quite terribly” with pediatric deaths during a major surge of influenza in 2009 and 2010.

“The intervention we’re talking about here is one that is something that we have accepted in the past to try to prevent deaths from influenza,” he said.

As of last month, there had been 202 deaths from Covid among children 6 months through 4 years old, according to death certificate data, considered a conservative count.

When the advisory committee met on Tuesday, officials from the Centers for Disease Control and Prevention said more than half of the children 6 months through 4 years old who have been hospitalized with Covid had no underlying medical conditions.

During the Omicron wave last winter, they said, young children were hospitalized at a higher rate than older children and adolescents, and their illness tended to be at least as severe, if not worse.

The nation’s roughly 20 million children younger than 5 are the only age group not yet eligible for coronavirus shots. If they are authorized, the Moderna pediatric vaccine would be available to children through age 5 and the Pfizer-BioNTech shot would be for children through age 4.



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