The FDA review for an emergency use authorization of Moderna’s Vaccine for adolescents as young as 12 years old is being delayed as the agency takes a deeper look into a possible 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.


According to the CDC, reported cases of myocarditis have occurred usually a few days after getting the COVID 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 their COVID-19 vaccine for children aged 6 to 11.


“It is estimated that over 1.5 million adolescents have received the Moderna COVID 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.


Pfizer is the only company whose vaccine is authorized for children as young as 12. On Friday, the FDA also authorized its vaccine for children between the ages of 5 and 11 years old for emergency use.

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