FDA Requires Pediatric COVID-19 mRNA Trials to Include Younger Children

The US Food and Drug Administration (FDA) has required COVID-19 mRNA vaccine developers expand their ongoing pediatric clinical trials to now include children aged 5-11 years old, in order to evidence potential risk of rare adverse events including myocarditis and pericarditis, according to a report Monday.

The requirement sent to Pfizer-BioNTech and Moderna includes an expectation of 3000 children from this age group included in the companies’ assessments of two-dose mRNA vaccines BNT162b2 and mRNA-1273, respectively, for the prevention of COVID-19 in children.

Timelines shared by Pfizer and Moderna spokespersons at the time of the report indicate the former company may be able to expand its pediatric trial size in time for an Emergency Use Authorization (EUA) indication for children by the end of September, while the latter company would seek an EUA in late 2021 or early 2022 depending on new younger pediatric patient recruitment.

The prevalence of myocarditis and pericarditis in younger persons vaccinated for COVID-19 is rare, yet nonetheless a point of concern for possibly expanded EUAs into pediatric populations. A report from the Centers for Disease Control and Prevention (CDC) last month showed BNT162b2 and mRNA-1273 administrations may been linked to approximately 1200 Americans experiencing either adverse event; about 500 such patients were younger than 30 years old.

That said, the incidence of (frequently mild) cases occurred at a rate of <13 cases per 1 million second vaccine doses—and COVID-19 infection itself is associated with increased risk of myocarditis and/or pericarditis.