Moderna has submitted an application to be able to vaccinate children aged 6 to 11 in Europe

The Moderna vaccine is currently approved for people over 12 years of age by the EMA
Moderna has submitted an application for approval of its Covid-19 vaccine for children aged 6 to 11 to the European regulator, the US biotechnology company announced on Tuesday.

The dosage of two injections, given four weeks apart, was adjusted to 50 micrograms, instead of the 100 micrograms used in older people.

“We are pleased to announce the submission of this variant to the EMA,” said Stéphane Bancel, head of Moderna, in a statement. “This marks our first application for use in this age group,” he said.

The Moderna vaccine is currently approved for those aged 12 and over by the EMA. But many countries, including France on Monday, have advised against using Moderna in those under a certain age (30 in France), due to concerns about the risk of myocarditis.

This side effect has been detected mainly in teenagers and young adults, especially men. However, at the end of October, Moderna announced positive results in its clinical trials for children aged 6 to 11, in which the vaccine provoked “a strong immune response” with “robust” antibody levels.

On Tuesday, the company released more details, saying that two weeks after the first dose, the vaccine was 100% effective against confirmed cases of Covid causing symptoms (such as fever, cough, loss of taste, etc.), or one of those symptoms and pneumonia. These results, however, remain preliminary.

The EMA is also studying data from Pfizer, which has applied for approval of its vaccine for children aged 5 to 11. That first review could be completed in December, it was reported last week.

The Pfizer vaccine has already been approved for this age group in the United States, while Moderna’s vaccine is not yet approved for use by people over 18 years of age.

The company announced in late October that it would not submit its application for the 6- to 11-year-old group to the U.S. Food and Drug Administration (FDA) until the agency completes its review of the vaccine for 12- to 17-year-olds.

The FDA has delayed approval of the Moderna vaccine for people ages 12 to 17 to allow time to better evaluate the risks of myocarditis. That evaluation may take until January 2022.

Fuente
AFP

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