Moderna says its vaccine for ages under 6 will be ready for U.S. review in June

A healthcare professional prepares a syringe with the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the COVID-19 pandemic in Manhattan, New York City, on January 29, 2021.

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Modern’s chief physician said Sunday that the company’s vaccine for children under 6 will be ready for review by a Food and Drug Administration panel when it meets in June.

On Thursday, Moderna sought permission for emergency use from the FDA.

An advisory panel of experts to the U.S. Drug Regulator will meet in June to review the request.

“I think the FDA now has all the basic data they need to be able to begin an application review. So yes, we are very confident,” said Dr. Paul Burton, the company’s chief physician, in an interview with CBS ‘”Face the Nation.”

Moderna’s vaccine may be the first to win US approval for children under 5 years of age. Pfizer also expects to have its vaccine data for children under 6 ready by the June review.

“The safety profile we have seen in this vaccine in these very young children is very reassuring – actual rates of safety incidents are even lower than we have seen in the 6-year-olds to 12-year-olds, and it is amazing.” said Burton.

Modern vaccine is FDA approved for use in adults 18 years and older. However, it has not yet been approved for 6- to 17-year-olds in the United States, despite being approved for that age group in Australia, Canada and the EU. U.S. regulators have asked the company for more safety data.

Burton said Sunday that the company is testing another booster shot, which he believes will be superior to booster results, as the company announced on April 19. The booster shots target the Beta variant plus the original coronavirus.

Moderna expects to have large quantities of a new booster vaccine by the fall to protect against Omicron and other Covid-19 variants, he said.

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