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Multiple sources told The New York Times that the move is to help detect cases of rare heart inflammation that have occurred in vaccinated people under age 30.
When the studies began, Pfizer and Moderna has been asked to include at 3,000 children between ages five to 11.
However, the companies are now being asked to as much as double the number of pediatric participants.
Pfizer-BioNTech and Moderna are being asked by the FDA to expand the number of children aged 5-11 in their COVID-19 vaccine clinical trials. Pictured: Eloise LaCour, three, gets either a vaccine or placebo as part of Phase 1 clinical trials of use of the Pfizer-BioNTech vaccine
Pfizer has previously said it hoped to apply for emergency use authorizations for its vaccine among ages five to 11 in late September or early October.
A spokeswoman for the company told The Times on Monday that the timeline was still on schedule despite the FDA request.
Meanwhile, Moderna spokesman Ray Jordan confirmed to the newspaper that the company is increasing the size of its trial ‘to enroll a larger safety database which increases the likelihood of detecting rarer events.’
Jordan says Moderna plans to file for emergency authorization for its vaccine in children above age five in ‘winter 2021/early 2022.’
An FDA spokeswoman, Stephanie Caccomo, declined to provide details in including when the decision to expand the trials was made and why.
‘While we cannot comment on individual interactions with sponsors, we do generally work with sponsors to ensure the number of participants in clinical trials are of adequate size to detect safety signals,” she told The Times.
Last month, an advisory group for the Centers for Disease Control and Prevention say there is a ‘likely link’ between rare cases of heart inflammation in adolescents and young adults and the Pfizer/BioNTech and Moderna COVID-19 vaccines.
In a presentation released on Wednesday, the COVID-19 Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of the heart inflammation, known as myocarditis, in vaccinated adults under age 30.
Myocarditis can be caused by a variety of infections, including a bout of COVID-19, as well as certain medications.
At the time, around 90.6 million young Americans under age 30 had received one or both doses of the Pfizer and Moderna vaccines, meaning just 0.000534 percent of people who have been administered the shots have reported such an effect.
However, the group did not detail any cases that occurred in children under age 12.
Although children can contract COVID-19 and pass it on to adults, they are much less likely to fall severely ill and die.
Currently, children under age 18 make up 14 percent of all cases to date and just 0.1 percent of all Covid-related deaths in the U.S., according to the American Academy of Pediatrics.
Polls suggest that parents are 50/50 about vaccinating children with a recent CDC report suggesting 56 percent of parents of 12-to-17-year-olds plan to vaccinate their children.
This is a breaking news story and will be updated.