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Moderna asks FDA to authorize first COVID-19 vaccine for very young children

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(NPR) – Moderna announced Thursday that the company has asked the Food and Drug Administration to authorize a low-dose version of its COVID-19 vaccine as the first vaccine for children younger than age 5.

In a study involving about 6,700 children, the company said two-doses of the vaccine administered 28 days apart to children ages 6 months to less than 6 years triggered levels of antibodies equivalent to what has protected older children and adults.

“We are proud to share that we have submitted for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, Moderna’s chief executive officer, in a statement. “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 vaccine appears to be about 51 percent effective for children ages 6 months to less than 2 years, and 37 percent effective for those ages 2 to less than 6 years, the company says.

“That means that you’re going to reduce your chances of getting disease by about a half. That’s very important for these kids,” Dr. Paul Burton, Moderna’s chief medical officer, told NPR in an interview.

While that level of effectiveness is lower than many had hoped, it’s not surprising given the study was conducted when omicron was the dominant variant, company officials and others say. Omicron can evade immunity better than previous variants, resulting in more “breakthrough” infections among vaccinated older children and adults.

But “the levels of antibodies that we see clearly shows that we should have very good protection against severe disease and hospitalization, which obviously is what counts most,” Burton said.

Read more.

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