The U.S. Food and Drug Administration has urged Pfizer and Moderna to expand their clinical trials for children 5 to 11 years old, amid cases of heart inflammation among those under 30 years of age who had been vaccinated, The New York Times reported Monday.
Emergency-use authorization (EUA) for pediatric vaccinations will be coming soon, President Joe Biden vowed last week, but he did not provide a specific timeline. The report could not make clear whether the expanded studies of younger vaccine candidates would slow the process.
The FDA has determined that the scope of Pfizer-BioNTech and Moderna pediatric vaccination studies was not adequate to detect inflammation of the heart muscle (myocarditis) and inflammation of the lining around the heart (pericarditis), sources familiar with the trials told the Times.
The FDA is asking the companies to study 3,000 children 5 to 11 years old, reportedly twice the number included in the original trials, sources added.
Moderna plans to expand its trial "to enroll a larger safety database which increases the likelihood of detecting rarer events," spokesman Ray Jordan told the Times, adding that Moderna is "actively discussing" the FDA proposal.
Pfizer might be ahead of Moderna, according to the Times, with the potential to accommodate the FDA parameters and file a EUA by the end of September, which would be near the start of the new school year across the U.S.
It would take a least a few weeks to review the data and study before EUA could be granted by the FDA, the Times reported.
Despite the rare cases of heart inflammation, the Centers for Disease Control and Prevention's COVID-19 vaccine advisory committee has estimated the benefits of shots for those older than 12 still outweigh the risks of rare side effects, according to the report.
"There's always a human price to pay for knowledge," Dr. Paul A. Offit, an infectious disease expert and pediatrician, told the Times.
The CDC published data in June showing more than 1,200 Americans — just 500 younger than 30 — had developed myocarditis and pericarditis potentially from being vaccinated. The symptoms appeared within two weeks and were most common among boys and young men.
Pfizer received an EUA from the FDA for children 12 to 15 in April, while the Moderna vaccine has received an EUA only for those 18 and older and attached a warning in June about heart inflammation as a potential side effect.
As of last week, according to the American Academy of Pediatrics, there have been 346 deaths and more than 4 million cases of COVID-19 among American children and adolescents since the start of the pandemic.
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