A difficult reality, though, is that many are already used off-label in children; Before 2003, when the law The licensing rules have changed, There was no need to test their medication before the children were prescribed. A 2019 study It was found that doctors used off-label medications for children during five outpatient visits, usually antibiotics, although other classes were also prescribed off-label. This type of frequent use creates challenges for physicians and pharmacists who stress that Covid is different.
“In other cases of off-label prescription of drugs approved for adults, pediatric use is very slow, usually one case report at a time, unless there is sufficient knowledge base to stop or expand pediatric use,” said Shannon Monji, an assistant professor of pediatrics and Harvard. The director of safety and quality at the medical school’s pharmacy department told Wired via email. “If thousands of children receive the vaccine at once, without adequate time to review the vaccine manufacturer’s test in children, we have lost the ability to confirm efficacy and identify any problems before they reach the general public.”
Still, Manji writes, pharmacists are already feeling the pressure to give the vaccine. Ashley Duty, pharmacy manager at Children’s Mercy Hospital in Kansas City, Missouri, said the same. “When we heard that the FDA was going to approve the Pfizer vaccine, our team started a conversation and made sure we were going to get together on this,” he said. “The feeling I’ve heard from everyone I’ve talked to is that we feel pressure – but we’re not comfortable with what was allowed and under 12 because we’re still in the middle. Pediatric research to determine the best dose. “
The Pfizer trial design divides children under 12 from 6 to 23 months, from 2 years to just 5 years, and then from 5 to 11 years, and determines different doses for each group based on their average age, size. Potential maturation of their immune system. Those doses have been made public, and clinics at some social chat last week Post them again, As a hedge against anyone who is mistakenly trying to use the vaccine off the label. “The first thing is to make sure they use the right dose, because if you use the adult dose, people will have a lot of side effects,” said David Boulevard, an adult infectious disease physician and professor at the University of Minnesota Medical School. “Hopefully, if people use the vaccine off-label, they will use the same dose in third-degree pediatric tests.”
Getting the vaccine off-label may not be as easy as it sounds. For one thing, babies are dosed Tiny, Doses as low as 3 micrograms are not prepackaged individually; It must be pulled from a vial. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-Systems Pharmacists, said now that the vaccine is being used from vials, it will be easier to make incomplete and very large doses. Once the vaccine is fully approved, it is expected to change, with a different formula or thinner version available for children. But now it’s a hurdle.
Another hurdle: the unique way of distributing the covid vaccine. These are still under the control of the federal government, which pays for them, so getting them from a hospital pharmacy or medical office is not as easy as asking a medical-product distributor for delivery. Institutions that have signed the vaccine Promise In advance with the CDC about how they will distribute them. Breaking these can lead to professional reactions. In fact, during Monday’s ACIP meeting, there was an unspecified addition to the program: a brief statement from a CDC staff member who, without mentioning any recipients, warned that using the vaccine off the label could prevent providers from compensating for the vaccine-injury. Make them legally liable for the claim, and jeopardize their permission from the CDC to supply the vaccine.