The difficulties in enrolling teenagers for vaccine test trials.

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Thu, 2021-02-18 17:06 — mike kraft

Teenagers contract the novel coronavirus almost twice as often as younger children but vaccines authorized in the United States are mostly for adults — Moderna’s for 18 and older, Pfizer’s for 16 and up.

While teenagers don’t become severely ill from the virus as often as adults, research suggests that because they are often asymptomatic and casual about social distancing, they can be efficient spreaders — to one another as well as to adults like parents, grandparents and teachers. Although vaccinating educators will be an important factor in keeping schools open, vaccinating students will also be a key element.

Bottom line: If widespread immunity to the coronavirus is to be achieved, adolescents are critical links. They need a Covid vaccine that works for them.

But teenagers are harder than adults to enroll and keep in clinical trials. They are difficult to wrangle and not so great with compliance, which includes keeping a symptom diary and keeping appointments, as many as six a year, that include blood draws (for some, an instant deal breaker).

To reach students, some researchers have tapped school connections, local pediatricians and social media campaigns. While waiting for appointments in the vaccine research clinics, some teenagers, ignoring advice to keep their vaccine volunteering off of social media, have posted TikTok videos, which have inspired friends to sign up. But the adolescent Covid vaccine trials will be much smaller than the adult trials — two or three thousand subjects instead of 30,000.

“You want to enroll as many kids as necessary but as few as possible, to expose as few as possible,” said Dr. Robert W. Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center.

To enroll in a trial, children must give “assent,” a legally required, age-appropriate version of “consent.” But researchers must also obtain the parent’s consent or permission. Information sessions for each can be protracted and painstaking. Objection by either child or parent terminates the application. ...

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