Moderna Asks FDA to Authorize COVID Vaccine for Kids Under 6 – CNET [CNET]

If authorized, it will be the first COVID vaccine available for very young children.

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Moderna has asked the Food and Drug Administration for emergency use authorization of its COVID-19 vaccine for children who are 6 months through 5 years old, the company said Thursday. 

If authorized, it will become the first COVID-19 vaccine available to babies and toddlers. Pfizer’s and BioNTech’s COVID vaccine is currently authorized and available for children 5 and older. Moderna said its full submission will be complete next week, which will include more data that the FDA will need to grant an EUA. 

The pharmaceutical company announced promising trial results in March and said it planned to seek FDA authorization for younger kids based on results on two doses of its 25 microgram vaccine (one-fourth of the volume of the adult Moderna dose). According to Moderna, the clinical trial found neutralizing antibody responses similar to what’s seen in adults and a favorable safety profile in both groups studied: children ages 6 months to 2 years and children ages 2 through 5.

Pfizer continues to work toward emergency use authorization for its COVID-19 vaccine for children under age 5. A Pfizer EUA was the initial hope for many parents waiting to get young children vaccinated against COVID, but Pfizer postponed its application to wait for additional data on a third dose for that age group.

The FDA said in a statement that it will share information soon on scheduling a meeting with its independent advisory committee, which will discuss Moderna’s request. 

“We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach,” an FDA spokesperson said. 

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