As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization.
In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech.
Since then, FDA has substantiated the risk of myocarditis, or heart inflammation, from mRNA vaccines, which is rare and tends to be minor.
According to The New York Times, federal regulators concluded that the proposed clinical trials to study the Pfizer and Moderna vaccines in school-aged children were insufficiently powered to detect rare side effects, including heart inflammation.
[Related: AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study]
Pfizer (NYSE:PFE) and BioNTech (NASDAQ: BNTX) announced in June that it was expanding its COVID-19 vaccine trial to include up to 4,…