Tue, 30 Nov 2021

Moderna not yet approved for vaccinating U.S. teens

Robert Besser
21 Oct 2021, 10:38 GMT+10

WASHINGTON D.C.: Before granting approval for use in young people, the Food and Drug Administration (FDA) is studying whether Moderna's COVID-19 vaccine could increase the risk of a rare inflammatory heart condition in teenagers.

Sweden, Denmark, Finland and Norway have limited or suspended the use of the Moderna vaccine for people under the age of 30, due to concerns of it causing an inflammation of the heart in younger men.

The Moderna and Pfizer vaccines have also both been linked to rare cases of myocarditis in children.

The FDA is re-assessing related data and comparing the results to statistics on the Moderna and Pfizer vaccines, but regulators have not determined if either vaccines carries increase risks.

Until the review is complete, the Moderna vaccine cannot be given to young people, while the Pfizer vaccine has emergency approval for use on children aged 12 to 15, as the company has submitted related trial data.

In an interview with the Wall St. Journal, Moderna Chief Medical Officer Paul Burton said, "I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products."

FDA data on vaccinations among those aged 18 to 25 showed no significant difference in the rate of myocarditis among people who were vaccinated with Moderna or Pfizer, he added.

In a study on 3,700 adolescents given the Moderna vaccine, none developed myocarditis.

The study was submitted by Moderna to the FDA, in a bid to have its vaccine approved for its use in children aged 12 to 17 years old.

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