Moderna to seek emergency authorization for Covid vaccine for young kids
Moderna announced Wednesday that its Covid-19 vaccine generated immunity protection for children 6 months to 6 years old.
In a trial of roughly 6,700 children in the age groups, two doses of 25 micrograms of the vaccine generated similar immune protection against the virus in kids as two 100 microgram-doses of the vaccine did for young adults. However, as the Omicron wave hit the U.S., real-world effectiveness was less robust: Kids 6 months to 2 years were 43.7 percent protected and kids 2 to 6 were 37.5 protected against any form of disease, though no children developed severe disease.
Side effects were similar in kids as they were adults. No one in the trial developed severe side effects, including myocarditis or pericarditis.
And for older kids: The company also announced that it had begun submitting data to Food and Drug Administration to authorize its vaccine for kids 6 to 11 years old, and that it was submitting additional data for those 12 to 17.
Background: Pediatric vaccines have proven a more difficult target for vaccine developers than adults. At the moment, the only vaccine available for children 5 and older is from Pfizer-BioNTech. In the U.S., there are roughly 19 million children younger than 5 for whom Covid-19 vaccines are not available.
Pfizer and BioNTech submitted data to FDA on two doses of their vaccine for children younger than 5. However, FDA postponed a vaccine advisory committee meeting to discuss this vaccine last month, electing to wait until the companies had more data on three doses of their vaccine. The companies began testing three doses of the vaccine in toddlers after trial data showed two doses didn't produce a robust enough immune response.
Meanwhile, Moderna has hit roadblocks as it develops its vaccine for children. Initially, Moderna sought authorization for its vaccine for children aged 12 to 17 in June 2021, though it has not received it yet as public health agencies monitor the risk of myocarditis risk for teens. In July, the company announced it would expand its vaccine trial to include children 5 to 11 years old. And in fourth-quarter earnings calls earlier this year, the company said it would be decreasing the dose size for that age group as well as toddlers and infants.
In 2020, FDA said that it would only consider authorizing Covid-19 vaccines that were at least 50 percent effective at preventing symptomatic disease.
What’s next: Moderna plans to ask the FDA to authorize the vaccine for this age group in the coming weeks. It is also planning to study booster doses for kids.
