The Food and Drug Administration’s review for an emergency use authorization of Moderna’s COVID-19 vaccine for adolescents as young as 12 years old is being delayed as the agency takes a deeper look into a possible rare heart risk, Moderna said on Sunday.
The review of the possible heart risk, a heart muscle inflammation called myocarditis, may push back approval until early 2022, the agency warned Moderna.
“The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said in a statement on Sunday.
According to the Centers for Disease Control and Prevention (CDC), reported cases of myocarditis have occurred usually a few days after getting the COVID-19 vaccine and mostly after receiving the second dose.
The CDC said that the heart risk has been reported after receiving either the Pfizer or Moderna COVID-19 vaccine mostly among young adults and male adolescents.
Moderna said that as a result of the delayed FDA assessment, it would delay filing a request to seek emergency use authorization of its COVID-19 vaccine for children ages 6 to 11.
“It is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population,” the company said.
“Moderna is committed to conducting its own careful review of new external analyses as they become available,” it added.
Moderna announced in June that it had filed for emergency use authorization for its COVID-19 vaccine for adolescents, after saying in late May that it was 100 percent effective in study participants.
So far, Pfizer is the only company whose vaccine is authorized for children as young as 12 years old. On Friday, the FDA also authorized its vaccine for children between the ages of 5 and 11 years old for emergency use, and it now awaits a decision by the CDC.