MODERNA VACCINE PROMPTS STRONG RESPONSE IN KIDS
Review of company’s data on children, teens had stalled
Moderna’s coronavirus vaccine elicits a strong immune response in children ages 6 to 11, researchers reported Wednesday — another signpost in what has become a long and tortuous road to protecting young children against the virus, even as cases again inch upward.
On Monday, Moderna requested authorization from the Food and Drug Administration for the vaccine’s use in this age group. But authorization, if granted, is unlikely to bump up the low immunization rates among young children by much.
The Pfizer vaccine has been available for children ages 5 to 11 since November, but as of Wednesday, 28.7 percent had received two doses. There is no coronavirus vaccine available for children younger than 5, forcing parents to rely on less reliable protective measures.
Last month, Moderna asked the FDA to authorize its vaccine for use in children 6 months to 6 years old. The agency is already reviewing the company’s data on adolescents and is expected to decide on use of the Moderna vaccine in children of all ages in June.
In February, Pfizer and its German partner BioNTech also sought authorization of their vaccine for use in the youngest children but withdrew the application after data suggested that two doses did not produce adequate protection against the Omicron variant.
The companies are banking on a third dose to shore up immunity in children, and the FDA is expected to review that data in June, as well.
“We really can’t do it this way in the future — we can’t leave children to the very last,” said Dr. Sallie Permar, an expert in pediatric vaccines at Weill Cornell Medicine in New York.
The process has been particularly confusing and unfair for parents of the youngest children, who still do not have access to a vaccine more than two years into the pandemic, she said.
It has been nearly a year since Moderna requested FDA authorization for use of its vaccine in adolescents ages 12 to 17. While the agency gave the go-ahead to Pfizer’s vaccine for use in that age group in just three weeks, its review of Moderna’s vaccine had stalled.
The delay in authorization has been longest in the United States. Europe’s drug regulators approved Moderna’s vaccine for adolescents ages 12 to 17 this past summer, and has recommended approval for children ages 6 to 11.
In the United States, just more than 1 in 4 of the 28 million children ages 5 to 11 have been immunized against the coronavirus.