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The difficult reality, however, is that many medications in children are already used off-label; Before 2003, then legislation has changed the licensing rules, there were no conditions before the drug was ordered to be tested on children. A 2019 study found that doctors had been using children’s medications without registration for nearly five outpatient visits, mostly antibiotics, although other classes were also prescribed without a label. Using it so often poses challenges for doctors and pharmacists who are under pressure to prove that Covid is different.
“In other unlabeled medications approved for adults, child use occurs very slowly, with a case-by-case report each time until there is enough knowledge to stop or expand children’s use,” said Shannon Manzi, assistant professor of pediatrics and director of safety and quality at Harvard Medical School. , He told WIRED by email. “If thousands of children receive the vaccine at the same time, without time to properly analyze the data from the vaccine manufacturer’s tests, we have lost the ability to ensure effectiveness and detect any problems before reaching the general population.”
However, Manzi wrote that pharmacists are already feeling the pressure to get rid of the vaccine. The same was said by Ashley Duty, pharmacy director at Children’s Mercy Hospital in Kansas City, Missouri. “When we heard that the FDA would approve the Pfizer vaccine, our team started a conversation and they made sure we would agree on that,” he said. “The feeling I’ve heard from everyone I’ve talked to is that we feel pressure, but we don’t feel comfortable expanding what is allowed and being under 12. Because we’re still in the middle of determining the best dose for children’s exams.”
The design of the Pfizer trial divides children under 12 into three age groups — 6 to 23 months, 2 to 5 years, and 5 to 11 years — and assigns a different dose to each group for their average age, size, and likely maturity of their immune systems. These doses have been made public, and in some social conversations in the past week, by clinicians he has published them again, making a mistake as a cover against anyone trying to use the vaccine off-label. “The first thing is to make sure they use the right dose, because if you use the adult dose people will have too many side effects,” says David Boulware, an adult infectious disease doctor and professor at the University of Minnesota School of Medicine. “Fortunately, if people use the vaccine off-label, they will use the same dose that is being tested in Phase III children’s trials.”
Not getting the vaccine label may not be as easy as it sounds. On the one hand, they are the child’s doses tiny, As low as 3 micrograms. This dose is not individually pre-packaged; must be taken out of a bowl. Working ad hoc from the vaccine containers currently in use would make it easy to be inaccurate and overdose, says Michael Ganio, director general of pharmaceutical practices and quality at the American Association of Health System Pharmacists. Once the vaccine is fully approved, it is expected to change, with another formula or diluted version for children. But it is an obstacle now.
Another hurdle: a unique way of distributing Covid vaccines. They are still under the control of the federal government that pays them; so getting it on behalf of a hospital pharmacy or medical office is not as easy as requesting a delivery from a distributor of medical products. Entities that distribute signed vaccines commitments Find out in advance with the CDC how they will be distributed. Breaking them can have a professional impact. In fact, at Monday’s ACIP meeting, there was an unscheduled increase on the agenda: a short speech by a CDC employee, without specifying which recipients were discussing, warned them that the use of the vaccine outside the label could not be returned to providers. having legal responsibility for vaccine injury claims, and jeopardizing the CDC’s permission to continue to administer the vaccine.
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