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Not enough young people are signing up for Moderna’s COVID-19 vaccine trial, a federal official said this week, possibly delaying vaccination clearance for this age group.
Last month, the U.S. Food and Drug Administration used OK of the Pfizer BioNTech vaccine for 16- to 17-year-olds as well as adults. The companies did not have enough data from younger young people to apply for use in that age group, and Moderna had only tested its vaccine in adults, so it is only approved for 18 years and over.
About four weeks ago, Moderna launched a trial with 12- to 17-year-olds, but apparently the company is struggling to find enough young volunteers.
Moncef Slaoui, the scientific director of Operation Warp Speed, the government’s vaccine effort, said on Tuesday that while a vaccine study in adults goes to 800 volunteers a day, the teenage trial gets only approx. 800 pr. Month.
The study needs at least 3,000 participants, he said, to provide valid safety and efficacy data and obtain FDA approval.
“It’s really very important for all of us, for the entire population of America, to realize that we can not have this indication unless teens ages 12 to 18 decide to participate,” Slaoui said.
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Although teens do not have very severe cases of COVID-19, they can get sick and they can transmit the virus that causes the disease. More than 2 million minors were diagnosed with COVID-19 by 2020, and many more were likely to get the disease but were never diagnosed.
In the fall, U.S. counties with large colleges or universities holding personal classes saw a 56% increase in COVID-19 cases after classes began, and college students gave the 19 hottest outbursts in the U.S. during the fall semester.
Children and teens may not bear much of the burden of infection, but they “bear a disproportionate burden of the overall pandemic impact,” said Dr. Lee Savio Beers, president of the American Academy of Pediatrics and professor of pediatrics at Children’s National Hospital. “We must not forget that.”
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Children’s schooling has been disrupted along with their social life and leisure activities. It happened at a time when their brains are still growing and evolving, “there is the potential for long-term effects for them” than for adults, Beers said. “It really is a crisis situation.”
While COVID-19 is generally mild in children, in rare cases it can cause serious illness and even death. At least 172 American children had died of COVID-19 per. December 17 compared to 166 who died of influenza in the 2019-2020 flu season.
A spokesman for Pfizer said the company hopes to have data from 12-15-year-olds in the early part of this year and then, based on these findings, could start a trial with younger children in the spring.
Moderna, for his part, said the trial is going well. “While enrollment was lower during the holiday season, we expect to see an increase in the new year as planned. We are on track to provide updated data around the middle of the year 2021,” a spokesman said via email. (More details about the trial are available here.)
Vaccines tend to be tested in adults and then teenagers before being tested in younger children and babies who may need lower doses or have different reactions.
Dr. Yvonne Maldonado, an infectious disease and global health expert at Stanford University School of Medicine, said getting vaccine data for children of all ages is crucial.
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“Many of us want to see children vaccinated – for their own safety, of course, but also because it really reduces the transmission chain,” said Maldonado, chairman of the American Academy of Pediatrics’ Committee on Infectious Diseases.
But the fact that COVID-19 is usually so mild in minors makes it difficult for parents to justify enrolling their children in trials, she said.
“If the disease was something that very clearly affected them in a huge negative way, you would probably see more interest there,” she said.
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Although parents want their children to participate, it can be difficult to get a busy youth to participate in the two-shot process. “It’s a pretty contradictory group in general,” remarked Maldonado, a mother of three, now an adult.
Legally, children over the age of 7 must agree to participate in a lawsuit even if their parent signs it.
Experimental volunteers receive two shots of the vaccine at 3-4 week intervals and their blood is drawn several times.
There are still plenty of parents and teens who want to participate in vaccine trials, said Dr. Barbara Pahud, a specialist in infectious diseases in children and research director of the Department of Infectious Diseases at Children’s Mercy Hospital in Kansas City.
Pahud is not helping run pediatric trials yet, but she plans to, and expects many in her community and elsewhere will be involved when word of the trials comes out.
“A month from now, the situation may look very different,” she said.
Pahud said she is not surprised that Moderna takes longer to log on to teens than adults. Pediatric trials, she said, are simply accustomed to a slower pace. “There is no reason to expect them to sign up at the same rate” as adult trials, she said.
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The federal government and vaccine manufacturers have not put as much emphasis on testing vaccines in children or pregnant women as they did in adults, Pahud said – not including any of the groups in the preliminary studies – and that needs to change if they want to increase the pace. .
Dr. Robert Frenck Jr., director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center, said he is also not surprised that enrollment so far has been slow in Moderna’s trials.
“When you move into a new age group for a vaccine / drug, it takes some time to build momentum,” he said via email.
Timing also makes it harder to vaccinate minors, he said. While clinical trials are generally set to run during everyday life, children are not available until after school, reducing the time available to enroll them, he noted.
Frenck, who helps run the Pfizer trial with young people, said his pace was initially low as well.
“But when teens signed up, many told their friends about the study, which significantly increased enrollment,” he said, adding that he also expects it to happen with Modern’s lawsuit.
If they can stick to current schedules, both vaccines may be available to adolescents before the start of the 2021-22 school year, although it is still unclear when they will be approved for use in younger children.
Contact Karen Weintraub at email@example.com.
Coverage of health and patient safety in the United States DAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare. Masimo Foundation does not provide editorial input.
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