FDA seeks to increase numbers of children in COVID-19 vaccine clinical trials, reports say

Coronavirus

RALEIGH, N.C. (WNCN) — The FDA is asking COVID-19 vaccine makers to increase the number of children in their clinical trials, according to an article by the New York Times.

Kira Kroboth can’t wait for her three children to get their COVID-19 shots.

“I feel like our kids are about to get slammed with the new variant coming out,” she said. “It’s hitting the unvaccinated, and they’re unvaccinated.”

Though shots aren’t usually high on the wish lists of children, 11-year-old Asher Kroboth is ready for the vaccine.

“I’m excited about it,” he added.

Clinical trials are already underway for children under 12, but according to the New York Times, the FDA has asked Pfizer and Moderna to increase the number of children in the studies.

“They really want to augment the numbers they initially came up with with the companies just to make sure they could look for any of the really rare side effects,” said UNC Infectious Disease Specialist Dr. David Wohl. “Especially the heart problems we’ve seen in some young people that transiently can happen after the vaccine.”

Heart inflammation cases were not seen during clinical trials in other age groups, but the FDA and CDC say they’ve confirmed 674 cases of myocarditis or pericarditis in vaccine recipients. Those numbers are out of more than 177 million people vaccinated.

Infectious disease experts say the more children in the study, the more confident people can feel about the results.

“I think it comes down to really statistics — we just need ‘X’ number of people so we can say with confidence that this is extremely rare,” he said.

“The benefits do have to outweigh the risks — we do have to understand what risks there would potentially be,” added RTI Epidemiologist Dr. Pia MacDonald. “It’s also very important for the public to trust this vaccine when it comes out for children. We need to know that it’s gone through all the right steps and there are no quick and unsubstantiated decisions.”

Having additional children in the studies may mean more time before the vaccine could go up for authorization.

“This gives them more power, if you will, to detect unusual type events, so I think the FDA is saying this would be worth it,” said Wohl.

Although Kroboth is eager for her children to be vaccinated, she says she understands the reasoning behind adding more children to the study.

“I feel like my kids are more at risk of COVID itself right now with their underlying health conditions, but I do want due diligence to be done science-wise and if they see a red flag, investigate it further,” she said. “We have to do right by our kids either way.”

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