Not enough teens are signing up for Moderna’s COVID-19 vaccine trial, a federal official said this week, potentially delaying vaccine approval for this age group.
Last month, the U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine for use in 16 to 17 year olds, as well as adults. The companies did not have enough data on younger adolescents to request use in this age group, and Moderna had only tested its vaccine in adults, so it is only licensed for those aged 18 and over. more.
About four weeks ago, Moderna started a trial with young people aged 12 to 17, but apparently the company is struggling to find enough volunteer teenagers.
Moncef Slaoui, the scientific chief of Operation Warp Speed, the government’s vaccination effort, said Tuesday that while an adult vaccine trial recruits 800 volunteers per day, the adolescent trial only receives ‘about 800 per month.
The study needs at least 3,000 participants, he said, to provide valid data on safety and efficacy and gain FDA clearance.
“It’s really, really important for all of us, for the entire American population, to realize that we can’t have that indication unless teens between the ages of 12 and 18 decide to participate,” Slaoui said.
COVID-19 disrupted schooling and killed at least 172 American children
Although teens tend not to have very severe cases of COVID-19, they can get sick and pass on the virus that causes the disease. More than 2 million minors were diagnosed with COVID-19 in 2020, and many more likely contracted the disease but were never diagnosed.
This fall, U.S. counties with large colleges or universities that ran in-person classes saw a 56% increase in COVID-19 cases after classes started, and students fueled the 19 hottest outbreaks in the states United during the fall semester.
Children and adolescents may not bear much of the burden of infection, but they “bear a burden disproportionate to the overall impact of the pandemic,” 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 this.”
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The children’s education was disrupted, as well as their social and extracurricular life. Occurring at a time when their brains are still growing and developing, “there is potential for longer-term impacts for them,” than for adults, Beers said. “It really is a crisis situation.”
Although 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 as of December 17, compared with 166 deaths from the flu during the 2019-20 flu season.
A spokesperson for Pfizer said the company expects to have data on children ages 12 to 15 by the start of this year and, based on those results, may begin a trial in young children in the spring.
For her part, Moderna said her trial was going very well. “Although registrations have been lower over the holiday season, we expect to see an increase in the New Year as expected. We are on track to provide updated data around mid-2021,” said said a spokesperson by e-mail. (More details about the trial are available here.)
Vaccines tend to be tested in adults and then adolescents before being tried in young children and babies, who may need lower doses or have different reactions.
Dr Yvonne Maldonado, an infectious disease and global health specialist at Stanford University School of Medicine, said getting vaccine data for children of all ages was crucial.
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“A lot of us want to see children vaccinated – for our own safety of course, but also because it really cuts the chain of transmission,” said Maldonado, chair of the American Academy of Pediatrics’ infectious disease committee.
But the fact that COVID-19 is generally so mild in minors makes it difficult for parents to justify enrolling their children in trials, she said.
“If the disease was something that was very clearly affecting them in an extremely negative way, you would probably see more interest in it,” she said.
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Even if parents want their children to participate, it can be difficult to get a busy teenager to participate in the two-step process. “It’s a pretty recalcitrant group in general,” said Maldonado, the mother of three, now an adult.
By law, children over the age of 7 must agree to participate in a trial, even if their parents sign it.
Trial volunteers receive two injections of the vaccine 3-4 weeks apart and their blood is drawn several times.
Still, many parents and teens want to participate in vaccine trials, said Dr Barbara Pahud, pediatric infectious disease specialist and research director for the infectious disease division of the Children’s Mercy Hospital in Kansas City.
Pahud is yet to help run pediatric trials, but she plans to do so and expects many in her community and elsewhere to want to join in on the news of the trials.
“In a month the situation could be very different,” she said.
Pahud said she was not surprised Moderna took longer to sign teenagers than adults. Pediatric trials, she says, are just used to a slower pace. “There’s no reason to expect them to register at the same rate” as the adult trials, she said.
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The federal government and vaccine makers haven’t put as much emphasis on vaccine testing in children or pregnant women as they did in adults, Pahud said – by not including either group in the initial studies – and that has to change if they are to pick up the pace. .
Dr Robert Frenck Jr., director of the Cincinnati Children’s Hospital Medical Center Vaccine Research Center, said he was also not surprised that recruitment so far has been slow in Moderna’s essay.
“Every time you enter a new age bracket for a vaccine / drug, it takes a little bit of time to build momentum,” he said via email.
The timing also makes it more difficult to vaccinate minors, he said. While clinical trials are usually held during the working day, children are only available after school hours, reducing the time available to register them, he noted.
Frenck, who helps lead the Pfizer trial in adolescents, said his pace was also slow at first.
“But, as the teens signed up, many told their friends about the study which drastically boosted enrollments,” he said, adding that he expects this also happens with the Moderna essay.
If they can stick to current schedules, both vaccines may be available to adolescents before the start of the 2021-2022 school year, although it is not clear when they would be permitted for use in adolescents. young children.
Contact Karen Weintraub at firstname.lastname@example.org.
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