Coming out of the ninth grade science period one recent Friday, the King twins had an excuse that is so much 2021.
© Brandon Thibodeaux for The New York Times
In Houston, Isabelle King, 14, is receiving her second dose of Jalleresse Flores’s Moderna vaccine, as her twin sister, Alexandra.
Alexandra and Isabelle, 14, had to miss the class – including a test – because they took part in an actual scientific experiment: a clinical trial with Moderna’s Covid-19 vaccine to evaluate whether the shot was effective and safe at children from 12 to 17.
“In science, we learn about genetics and things like that,” Alexandra said during the monitoring period after she was admitted to a clinic in Houston. So maybe the teacher will say, ‘Oh, you really do not have to take the test, because you’re already contributing to science. ”
Teenagers get the new coronavirus almost twice as often as younger children, but vaccinations allowed in the United States are mostly for adults – Modern for 18 and older, Pfizer’s for 16 and older. While teens are less likely to become seriously ill with the virus as adults, research suggests that they are often asymptomatic and comfortable about social distance, that they can be effective distributors – among themselves as well as adults such as parents, grandparents and teachers. . Although the vaccination of educators will be an important factor in keeping schools open, the vaccination of students will also be a key element.
© Maddie McGarvey for The New York Times
Audrey, 14, and Sam, 12, brother and sister, are taking part in the Pfizer trial in Cincinnati.
In short: if a broad immunity to the coronavirus is to be achieved, adolescents are an important link. They need a Covid vaccine that works for them.
But teens are more difficult to participate in as clinical trials than adults. It’s hard to wrestle with and is not as good with compliance, which includes keeping a symptom diary and keeping appointments, as many as six a year, which includes blood tests (for some an immediate appointment).
Some students have embarked on school connections, local pediatricians and social media campaigns to reach students. While waiting for appointments at the vaccine research clinics, some teens posted TikTok videos, which inspired friends to voluntarily keep their vaccination off social media. But the adolescent Covid vaccine trials will be much smaller than adults – two or three thousand subjects instead of 30,000.
© Brandon Thibodeaux for The New York Times
Jonah Proctor, 15, is awaiting his shot at a Covid vaccine trial site in Houston.
“You want to enroll as many children as possible, but as few as possible, to expose as few as possible,” said Dr. Robert W. Frenck, director of the vaccination research center at Cincinnati Children’s Hospital Medical Center, said.
To enter a trial, children must give ‘consent’, a legally required, age-appropriate version of ‘consent’. But researchers must also obtain permission or consent from the parent. Information sessions for everyone can be lengthy and meticulous. Objection by the child or the parent terminates the application.
“Parents may be willing to put themselves in a study, but not their children,” said Dr. James Campbell, an expert in infectious childhood diseases at the University of Maryland School of Medicine, who conducts vaccine trials, said. “Their key role in life, as parents, is to keep their children safe and they can choose to wait until a vaccine is licensed, rather than enrolling their child in a trial.”
Researchers often give young subjects extra precaution. Because information against vaccines and personal attacks is so widespread, youth volunteers should avoid discussing their role in the trial on social media.
Although the new coronavirus had far less impact on children than older adults, according to the Centers for Disease Control and Prevention, about 2.2 million children were reported in the United States and about 280 children died. About 2060 children have contracted a dangerous rare condition associated with the coronavirus called multisystem inflammatory syndrome, which can shut down the heart and other organs.
And like the calling of the enemy, the pandemic took over most children’s lives – shutting down school, sports, socializing. This has led some teens, who otherwise feel so powerless, to fight back by volunteering for vaccine trials.
Sam, 12, who entered the Pfizer trial at Cincinnati Children’s Hospital, said he wanted to participate “because it would help science and defeat the pandemic.” And that was my way of saying thank you to the frontline workers who keep us healthy. ”
His sister, Audrey, 14, who is also participating in the study, said: ‘I thought it would be a very good story I could tell my children and grandchildren – that I was trying to create the vaccine. . ‘
“And I also thought it was important to have people of different ages and races represented,” adds Audrey, who, like her brother, is Asian. (Their mother, Rachel, a nurse researcher who volunteered for a vaccine trial, requested that their surnames be withheld for privacy reasons.)
In general, the teen trials may be less diverse because results of adult trials show no observable difference in race outcomes. And because the trials for adults were so successful, up to two-thirds of teens could be offered the actual vaccine rather than a placebo.
Pfizer, whose trial is fully enrolled, expects the results of the trials for children aged 12 to 15 in the first quarter of this year, which it will then submit to the Food and Drug Administration for review. Modern is still recruiting for its adolescent trials, with data expected sometime this summer. Other businesses expect to begin adolescent trials soon. Shortly thereafter, researchers will open trials for children as young as 5 years old, probably with a more moderate dose.
As in any medical trial, investigators are treated equally when discussing risks and benefits. Instead of teaching young subjects, dr. Campbell, whose clinic will do a Modern trial for younger children, them in conversation.
“Do you remember your tetanus shot? Tell me about it, ”he can say. And then: “Here’s how it’s similar and how it’s different.” He wants to make sure that the teenager is actively involved in the decision making. “We always say, ‘Do not do this to your parents. ‘”
Dr Sarah Hasan, chief recruiter for DM Clinical Research, which oversees the Houston Fights Covid campaign and most of the city’s vaccine trials, said information sessions for adolescents and adults differ markedly. She has more fun with the teens.
“Usually adults look at the form, ask a few questions and they’re done,” she said. “But kids ask more questions than adults, and they actually listen, which is pretty fun.”
“Of course,” she added, “they also want to know if the doses will make it into zombies.”
During trials for adults, when the participants were listless and the results were unknown, no appointments were made, dr. Hasan said. But teens “arrive on time and are super-satisfying.”
Another problem with enrollment is compensation. Researchers usually offer volunteers money to cover time and travel costs, but the amount may not be substantial enough to look like an incentive. The current rate is about $ 15 per hour. The Cincinnati Pfizer trial also compensates parents by arguing that they contribute time and money as unofficial drivers for the young nationals.
In Houston, the King sisters were already fantasizing about how they would spend the money.
Alexandra’s impulses were immediately generous. Now she could buy gifts for others her father usually paid for. ‘It would definitely be something fun to do, as I deserved it by getting a shot in the arm to help people. And now I can at least buy Christmas presents for my mother, ”she said.
Her sister Isabelle hurriedly talked in that she would of course also use the money for something selfless. Then she admitted, “Well, my closet can use an update.”
This summer, Monica Mitchell, a Cincinnati Children’s Community Health Educator, participated in a Pfizer vaccine trial. Her daughter Melanie, a junior high school student, was deeply curious, but at that point volunteers had to be at least 16 years old. On the day she turns 16, Melanie calls to sign up.
Both mother and daughter became ambassadors for the vaccine. “Someone said to me, ‘You’re doing the white man’s job,’ says Melanie, who is black. “And I said, ‘No, it’s the opposite. I do the work for my people. ‘”
Dr. Mitchell, who is also a pediatric psychologist and researcher, suffered a slight setback because she allowed her daughter to be vaccinated. “Some family members asked, ” Why would you do that? ‘ But they at least understand that Melanie is quite independent and know that she has made her own decision, ‘said dr. Mitchell said.
Like most trial volunteers, children are concerned about side effects. Sure enough, after Sam got the second dose at Cincinnati Children’s Hospital, he had a hard time doing so.
In the middle of the night he wakes up with a throbbing headache. Then cold fever, low fever, muscle aches.
“He looked unhappy,” his mother, Rachel, said. “It’s one thing to talk theoretically about side effects, but as a mom it was hard to see how he felt really bad.”
She felt guilty for encouraging him to participate. “I’m so sorry,” she said.
Sam was surprised by her reaction. “I’m so happy,” he replies. “That means I have the right thing!”
Audrey, his sister, feels good after her dose. “I’m jealous,” she said.
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