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Advisers’ Backing on Vaccine for Kids Wins NIH Chief’s Support

Oct. 27, 2021, 7:05 PM

The NIH chief said he agreed with a scientific advisory panel’s decision to back Pfizer’s Covid-19 vaccine for kids, although he acknowledged gaps in data leave important questions looming.

“I side with the majority of the 17 people who voted yes. I would have voted that way too,” Francis S. Collins said in an interview Wednesday.

The comments from the longtime director of the National Institutes of Health—who’s stepping down by the end of the year—follow a recommendation from the Food and Drug Administration’s vaccine advisory committee. The committee voted Tuesday that the benefits of the vaccine by Pfizer Inc. and BioNTech SE exceed its risks for 5- to 11-year olds.

The vote is a critical step toward making vaccines available for all school-age children in the U.S. Pfizer’s vaccine has been authorized for everyone 12 and up since May, but everyone in that group receives the same 30 microgram doses. The 5- to 11-year old vaccine is a third of the adult dose.

Making a vaccine available to children in elementary school would mark a major milestone in the pandemic. Though kids generally don’t get as sick from Covid-19 as adults, schools have been at the center of public debate over U.S. virus policy, and providing children with a shield against infection is likely to be welcomed by many parents.

But even though the vote came out 17-0 with one abstention, the daylong meeting included extensive debate and concern about a lack of data on the side effects of the prevalence of previous Covid-19 infections in children and the shot’s ability to protect from variants.

“It is exactly the kind of conversation that should have happened because these are kids and you want to be sure you’re making a decision about a medical intervention, that you’ve looked at all the information and really sized up the benefits and risks,” Collins said.

One of the big questions during the debate focused on myocarditis, a heart inflammation that has been seen in some young males who have received messenger RNA vaccines. But in the study of about 3,000 kids ages 5 to 11, there were no cases of myocarditis seen in the clinical trial.

So it’s unknown whether myocarditis is going to be an issue for that age group, or if it’s basically something for older adolescents and young adults to make a benefit-risk calculation when deciding whether to get vaccinated, Collins noted.

“We had this big question mark in the middle of it,” Collins said. “What really is the risk in this age group? And we don’t know.”

The committee noted the risk of myocarditis with the vaccine tends to be rare, limited, and short-term, whereas the risk of myocarditis when caused by the disease itself is 37 times higher compared with those who haven’t been infected.

“So you shouldn’t compare a case of myocarditis from the vaccine with a case of Covid-19 that puts a kid in the ICU. One is much worse than the other,” Collins said.

Pfizer’s vaccine for 5- to 11-years will unlikely be available until next week at the earliest.

The FDA still needs to decide whether it will authorize the vaccine, which could happen in the next few days. If it does, the Centers for Disease Control and Prevention must conduct its own vetting in terms of who should get the shots. The CDC’s advisory committee is expected to meet Nov. 2-3.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editors responsible for this story: Brent Bierman at bbierman@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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