At FDA Urging, Pfizer and Moderna to Include Thousands More Children in Clinical Trials

Citing concerns about the risk of heart inflammation associated with the vaccines, the U.S. Food and Drug Administration asked Pfizer and Moderna to expand the number of children in their clinical trials.

Pfizer and Moderna will increase the number of children in their COVID vaccine clinical trials prior to seeking Emergency Use Authorization (EUA), after the U.S. Food and Drug Administration (FDA) told the vaccine makers the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.

The rare side effects cited by the FDA include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, multiple people familiar with the trials told The New York Times.

Moderna’s shot is authorized for emergency use in people 18 and up, and Pfizer’s vaccine is authorized for children as young as 12. No COVID vaccines have yet received EUA approval for children younger than 12.

Expanding the pediatric trials means thousands more children as young as 6 months old may soon be recruited and enrolled in COVID vaccine trials.

According to the Times, the FDA asked the companies to include 3,000 children in the 5- to 11-year-old group, the group for whom results were expected first.

One person, granted anonymity by the Times to speak freely, described that figure as double the original number of study participants.

Moderna researchers had intended to test the vaccine in about 7,000 children, with some as young as 6 months, according to ABC News, but the company told the news outlet today in an email they never decided on how many kids would be added to the trial.

Pfizer began testing its vaccine in children ages 5 to 11 on June 8, with those younger than 5 being included as of June 21. The study will involve up to 4,500 subjects from the U.S., Finland, Poland and Spain, according to the Wall Street Journal, which also reported the company declined to say whether the recent request from the FDA will change the timing of any authorization submissions.

Last month, Pfizer and Moderna said their vaccines for children 5 through 11 could be ready as early as September. Pfizer, which is on a faster timetable than Moderna, may be able to meet the FDA’s expectations on a bigger trial size and still file a request for expanded EUA by the end of September, the Times reported.

A federal official, who spoke to the Washington Post on the condition of anonymity because they were not authorized to speak publicly, predicted authorization of a COVID vaccine for children 5 through 11 might come by late October or early November.

The government is not expecting it will be a big problem to enroll more children because so many parents are eager to get their children vaccinated, the official said.

Heart inflammation in teens raises red flag

Moderna spokesman Ray Jordan told the Post the goal is “to enroll a larger safety database which increases the likelihood of detecting rarer events.”

According The Washington Post:

“The FDA wants to be particularly careful about the possibility of children developing myocarditis, or heart inflammation, after receiving a coronavirus vaccine. Adolescents who receive the vaccines are more likely to develop myocarditis than adults — though the risk remains small — and officials want to increase the chances that the trials will indicate whether there is increased incidence of heart inflammation in children.”

The Centers for Disease Control and Prevention in June acknowledged 1,200 cases of heart inflammation in 16- to 24-year-olds, and said mRNA COVID vaccines should carry a warning statement. The FDA followed by adding the warning.

According to the latest data available, the CDC’s Vaccine Adverse Event Reporting System has received 383 reports of myocarditis and pericarditis in vaccine recipients between the ages of 12 and 17 years old, with 379 cases attributed to Pfizer’s vaccine.

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