Moderna asks FDA to authorize vaccine for kids under 6

Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to submit an application for young children. 

There are currently no vaccines authorized for children under five, which has led to some frustration among parents over the pace as they are eager to see a vaccine become available.

Moderna’s move is a step forward on that front, but it still could be a few weeks before the vaccine is authorized.

The company said the application would become fully complete next week, and there still needs to be time for the FDA to review it and for an outside advisory committee to meet, which could be in June. 

Pfizer has previously said that authorization for its vaccine in children under five could be in June, though previous timelines have been pushed back before. 

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, Moderna’s CEO. “We believe [the vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

The company had previously announced that its vaccine for children under six produced a similar antibody response as the adult vaccine, a positive sign. 

The numbers on effectiveness, though, could be seen as relatively low: 51 percent for children under two, and 37 percent for children two to five. Still, experts have noted those data came during the omicron surge, and that the numbers for preventing severe disease are likely significantly higher. 

The FDA has said it is seeking to ensure that it follows its thorough process for review, with concern that parents need to have confidence in the vaccine. It has noted that for children 5-11, where a vaccine is currently available, uptake has been low, with only 28 percent of children in that age group fully vaccinated. 

That has prompted concern that uptake will also be low for children under five, once the vaccine does become available.