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.
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{Matzav.com}
