FDA advisers recommend COVID shots for 5 and under

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(The Hill) — Long awaited COVID-19 shots for the youngest children are one step closer to being available after a Food and Drug Administration advisory panel on Wednesday recommended the agency grant emergency authorization to vaccines from Pfizer and Moderna.

An outside Food and Drug Administration advisory panel on Wednesday unanimously recommended the vaccines should be authorized; Moderna’s for children between the ages of 6 months and 5 years, and Pfizer’s for kids 6 months to 4 years old. 

The FDA’s vaccine advisors voted 21 to zero to recommend authorizing Moderna’s vaccine, and then again 21 to zero in favor of Pfizer.

An advisory panel for the Centers for Disease Control and Prevention will meet this weekend to issue its own recommendation. If the panel votes in the affirmative and the CDC director signs off, children could start to get vaccinated as early as next week.

More than a year and a half since vaccines began rolling out for adults, kids under 5 are the last group eligible to be vaccinated. There are about 18 million of them who would become eligible. 

Peter Marks, the FDA’s top vaccine regulator, led off the meeting with a reminder that contrary to popular belief, young kids are at risk from COVID-19 even if they don’t get sick as often as adults.

According to Marks, 442 children younger than 5 had died of COVID through the end of May, a toll higher than for many other vaccine-preventable illnesses.

“We have to be careful not to become numb to the number of pediatric deaths because of the overwhelming number of older deaths. Every life is important and vaccine preventable deaths is something we’d like to do something about,” Marks said.

“Each child that’s lost essentially fractures a family,” Marks said.

But while the vaccines are largely interchangeable for adults, the pediatric versions are very different. The shots haven’t been tested against each other, so there’s no way to tell parents if one is superior.

Moderna’s two-dose mRNA vaccine is intended to be administered four weeks apart, and is one quarter the strength of an adult dose. Pfizer’s vaccine is three doses, spread much further apart. 

The first two doses of Pfizer’s shot are given three weeks apart, but the company recommends giving the third dose eight weeks after the second. The doses are also just one-tenth the strength of an adult vaccine, and the company found essentially no protection after two doses. 

FDA previously said the vaccines are safe and effective, though neither performed very well in preventing symptomatic disease, mainly against the omicron variant. 

Moderna found its vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children 2 through 5. Pfizer’s vaccine was only found to be about 28 percent effective against infection, though both prevented serious illness.



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