The U.S. Food and Drug Administration (FDA) delayed a decision on whether to approve Moderna’s CCP virus vaccine for children aged 12 and older, according to the pharmaceutical giant on Sunday.
The health regulator is investigating the risk of myocarditis, a form of heart inflammation, in children aged 12 to 17, Moderna’s statement said. The review may not be completed before January of next year, the company said.
“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, while adding that the “safety of vaccine recipients is of paramount importance to Moderna.”
Moderna added it would delay filing a request for an emergency use authorization for a smaller dose of its mRNA vaccine among children aged 6 to 11. Late last week, the FDA granted emergency use authorization of pharmaceutical giant Pfizer’s COVID-19 vaccine for children in that age group, although the U.S. Centers for Disease Control and Prevention (CDC) has to sign off on it before it can be distributed.
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
In the United States, Moderna’s two-dose vaccine is only available to those aged 18 and older. Several Scandinavian countries, including Finland and Sweden, issued statements earlier this month against providing the Moderna shot to younger adults and children—primarily younger males—due to the risk of myocarditis.
Sweden said it would pause the vaccine for people under the age of 30, and Denmark did the same for those under 18. Finland said that males under the age of 30 shouldn’t receive the jab, while Icelandic officials added over the weekend that they would suspend use of the shot. Last week, Swedish health officials extended their pause of Moderna’s vaccine .
