Moderna has asked the Food and Drug Administration for emergency use authorization of itswho 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 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 needs in order 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 has been seen in adults against the . The vaccine also had a favorable safety profile in both groups studied: children ages 6 months to 2 years and children ages 2 through 5.
The same trial also studied a vaccine for children ages 6 to 11 years. In March, Moderna said it will also ask the FDA to authorize COVID-19 vaccines for kids 6 to 11 and 12 to 17. If Moderna's vaccine for those age groups is authorized, there will be a second vaccine option for children in the US.
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 Pfizerto wait for additional data on a third dose for that age group. Pfizer and BioNTech are expected to complete their submission process soon.
In an interview with CNN Plus earlier this month, Chief Medical Advisor to the President Dr. Anthony Fauci suggested that the FDA might wait to review and compare data on Pfizer's and Moderna's child vaccines before issuing an EUA. Citing people with knowledge of the situation, Politico reported on April 21 that the FDA could authorize a vaccine for younger children as late as June.
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.
About 75% of children and teens in the US have had COVID-19 as of February 2022, according to a report published Tuesday by the US Centers for Disease Control and Prevention. During the omicron surge this winter from December through February, the COVID-19 hospitalization rate was about twice as high in children ages 5 to 11 who weren't vaccinated compared with kids who were vaccinated, according to a recent CDC report. Three in 10 children hospitalized during the omicron wave had no underlying conditions, the CDC said.
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