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Coronavirus

FDA advisers weigh COVID-19 shots for youngest kids

Published: Updated:

US government advisers are meeting Wednesday to decide whether to endorse COVID-19 shots for babies, toddlers and preschoolers, moving the nation closer to vaccinations for all ages.

Kids under 5 are the last remaining age group to get vaccinated and many parents have been anxiously waiting for months for regulators to act.

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An independent advisory committee will hear presentations from Moderna and Pfizer at an all-day meeting before voting on whether to recommend Food and Drug Administration authorization.

While only about 3 percent of US COVID cases are in the age group 6 months to 4 years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said protecting this group is important.

Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge’’ in young children’s hospitalizations during the omicron wave.

He noted 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said.

“We have to be careful that we don’t become numb to the number of pediatric deaths,” Marks said. “Each child that’s lost essentially fractures a family.”

FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting.

Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.

The two vaccines use the same technology but there are differences.

In a call with reporters earlier this week, vaccine experts noted that the shots have not been tested against each other, so there’s no way to tell parents if one is superior.

If the FDA clears the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday.

If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies.

Roughly 18 million youngsters would be eligible.

Read more:

US: Pfizer COVID-19 shot appears effective for kids under five

US to drop COVID testing for incoming international air travelers

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