Pfizer and Moderna are expanding the size of their COVID-19 vaccine studies in children ages 5 to 11, according to a new report.
The decision, which came after a push from the Food and Drug Administration, according to, is intended to detect rare side effects in young people under the age of 30, such as myocarditis and pericarditis . The original size of the studies was too small to detect those rare side effects.Pfizer declined to comment on The Times' report to ABC News and pointed to a vaccine timeline the pharmaceutical company had previously released.
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." It's unclear what effect these changes might have on the timeline for emergency use authorization for COVID-19 vaccines in children."The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events," according to Moderna."Timelines are regularly reevaluated based on agency discussions and requests.
"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," the agency told ABC News in a statement. In a statement last week, the FDA said:"Some of the advisory committee members have said they'd like to see a longer median follow up time after vaccination – more than the 2 months used to support FDA’s emergency use authorizations for older age groups – in the trials in the younger ages, which is something that the agency intends to take into consideration, though it is not bound by the recommendations of advisory committees or statements from advisory committee members during the...
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