FDA delays decision on Moderna vaccine for adolescents

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A nurse holds a vial of the Moderna COVID-19 vaccine. The company said Sunday that the U.S. Food and Drug Administration has delayed making a decision on approving emergency use of the jab on minors 12-17 years old over international instances of myocarditis. Photo by Debbie Hill/UPI | License Photo

The U.S. Food and Drug Administration requires more time to decide on whether to approve use of Moderna’s two-dose COVID-19 vaccine on adolescents 12 to 17 years of age, the pharmaceutical company said.

Moderna said in a statement on Sunday that it was notified Friday by the FDA concerning the need for more time to “evaluate recent international analyses of the risk of myocarditis after vaccination.”

An increased risk of myocarditis, the inflammation of the heart, has been associated with COVID-19 vaccines, including that which is made by Moderna, particularly in young men following the second dose.

In Japan, health authorities have allowed men under 30 who have received the Moderna vaccine for their first shot to receive a Pfizer-BioNTech jab for their second due to the risk, The Japan Times reported.

Japanese health officials have reported 21.60 suspected myocarditis cases per 1 million boys ages 10 to 19 who received the Moderna shot, which is a higher incidence rate compared to the 1.87 per 1 million who received the Pfizer-BioNTech shot.

In northern Europe, the Finnish Institute for Health and Welfare paused the administration of the jab to boys and men under 30 as have other Scandinavian countries.

The delay means Moderna, which had asked for emergency use authorization for minors in June, does not expect the review of its vaccine to be completed before January, it said.

“The safety of vaccine recipients is of paramount importance to 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,” it said.

The announcement was made days after the FDA cleared use of the two-dose COVID-19 vaccine by Pfizer-BioNTech for use in children ages 5 to 11 on Friday.

Moderna explained Sunday that more than 1.5 million adolescents have received its COVID-19 vaccine and the observed rate of myocarditis reported in this demographic does not suggest an increased risk of the illness in this population.

“Moderna is committed to conducting its own careful review of new external analyses as they become available,” it said, adding that it has yet to receive access to some of that recent international analyses.


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