(CMR) Pfizer and Moderna are expanding the sizes of their Covid-19 vaccine trials in children ages five to 11 at the request of the Food and Drug Administration (FDA), The New York Times reported Monday.
The move has been characterized as a precautionary measure to understand better rare side effects that have turned up in some young people under 30, such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart).
The original size of the studies was too small to detect those rare side effects, ABC News reported. The FDA has reportedly asked that 3,000 children in the 5-11age group be included in the studies.
The Centers for Disease Control and Prevention (CDC) released data last month showing around 500 of the 1,200 Americans who developed heart inflammation issues after receiving mRNA vaccines were under the age of 30.
Moderna told ABC News in a statement: “It is our intent to expand the trial, and we are actively discussing a proposal with the FDA.”
“The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” Moderna said.
The expansion of the trial could also see the vaccine approved for younger children by the end of 2021 to early 2022.