Pfizer and Moderna Double Clinical Trial Size for Ages 5-11

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Pfizer and Moderna are doubling the scale of their COVID-19 vaccine clinical trials targeting children aged 5 to 11.

The New York Times (NYT) reported on the 26th (local time), citing multiple sources, that "the U.S. Food and Drug Administration (FDA) requested this because the current trial size is insufficient to detect rare side effects such as myocarditis and pericarditis."

The vaccines developed using messenger ribonucleic acid (mRNA) technology by the two companies have been reported to cause side effects such as myocarditis and pericarditis in a very small number of recipients under 30 years old.

The FDA has ordered the number of participants in the pediatric clinical trials to be increased to about 3,000, double the previous size, to more closely monitor heart-related side effects.

The NYT stated, "It is still unclear whether the expansion of the clinical trials will delay the emergency use authorization of the vaccine for children aged 5 to 11."

However, Pfizer maintains its original schedule to apply for emergency use authorization for the vaccine for children aged 5 and older by the end of September. Moderna plans to request an expansion of emergency use authorization for children as early as the end of this year or early next year.

This content was produced with the assistance of AI translation services.