Not enough adolescents are signing up for Moderna’s COVID-19 vaccine trial, a federal official said this week, potentially delaying vaccine authorization for this age group.
Last month, the U.S. Food and Drug Administration OK’d use of the Pfizer-BioNTech vaccine for 16- to 17-year-olds, as well as adults. The companies did not have enough data in younger adolescents to apply for use in that age group, and Moderna had tested its vaccine only in adults, so it is authorized only for those 18 and up.
About four weeks ago, Moderna launched a trial in 12- to 17-year-olds, but apparently, the company is struggling to find enough adolescent volunteers.
Moncef Slaoui, the scientific head of Operation Warp Speed, the government’s vaccine effort, said Tuesday that while a vaccine trial in adults is accruing 800 volunteers per day, the teen trial is getting only about 800 per month.
The study needs at least 3,000 participants, he said, to provide valid safety and effectiveness data, and get authorization from the FDA.
“It’s really very important for all of us, for all the population in America, to realize that we can’t have that indication unless adolescents aged 12 to 18 decide to participate,” Slaoui said.
Although teens tend not to get very serious cases of COVID-19, they can get sick and they can pass on the virus that causes the disease. More than 2 million minors were diagnosed with COVID-19 in 2020, and many more probably contracted the disease but were never diagnosed.
This fall, U.S. counties with large colleges or universities that held in-person classes saw a 56% increase in COVID-19 cases after classes started, and college students fueled the 19 hottest outbreaks in the U.S. during the fall semester.
Children and teens may not bear much of the burden of the infection, but they are “bearing a disproportionate burden of the overall pandemic impact,” said Dr. Lee Savio Beers, president of the American Academy of Pediatrics and a professor of pediatrics at Children’s National Hospital. “We should not forget that.”
