Is Off -Label Prescriptions a Backdoor to Providing Covid Vaccines to Children?
A difficult reality, however, is that many medications are already being used unmarked in children; before 2003, when to legislate revised licensing rules, there is no need for medications to be tested on children before they are taught. A Study in 2019 found that doctors used unmarked medications for children in nearly one in five outpatient visits, usually antibiotics, although other classes were also prescribed unmarked. Such frequent use presents challenges for physicians and pharmacists under pressure to prove that Covid is different.
“In other cases of prescribing off-label medications approved for adults, the child’s use occurs slowly, usually a case of reporting each time, until there is a sufficient basis of knowledge to stop or increase use in children, ”Shannon Manzi, an assistant professor of pediatrics and director of safety and quality at the Harvard Medical School Department of Pharmacy, told WIRED via email. “If thousands of children receive the vaccine simultaneously, with no time for adequate analysis of data from the pediatric vaccine manufacturer’s trials, we lose our ability to ensure effectiveness and detection. any issues before reaching the majority of the population. “
However, Manzi writes, pharmacists have felt pressure to give the vaccine. Ashley Duty, the pharmacy manager at Children’s Mercy Hospital in Kansas City, Missouri, said the same. “When we heard that the FDA had approved Pfizer’s vaccine, our conversation started and made sure we were together about it,” he said. “The sentiment I hear from everyone I’ve talked to is that we’re feeling the pressure – but we’re not comfortable expanding on what’s approved and going even further under the age of 12. Because we’re still in the middle. in the child’s studies to determine what the best dose is. ”
Pfizer’s trial plan divides children under 12 into three ages – 6 to 23 months, 2 years to under 5, and after 5 to 11 years – and gives different doses to each group accordingly. of their average age, size, and the likely maturity of their immune systems. Those doses were made public, and in some social talk last week, clinics they were posted again, as a fence against anyone who tries to use the unmarked vaccine to be mistaken. “The first thing is to make sure they use the right dose, because if you use the dose in adults there are a lot of side effects,” said David Boulware, an adult infectious disease physician and professor. at the University of Minnesota Medical School. “Hopefully, if people use the vaccine unmarked, they will use the same dose studied in the Phase III pediatric trials.”
Getting the vaccine -marked vaccine may not be as easy as it sounds. For one thing, the child’s dose small, as low as 3 micrograms. That dose is not individually limited; it must be removed from a bowl. Working ad hoc from the vaccine bowls in use today, can easily be inaccurate and produce multiple doses, said Michael Ganio, who is senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Once the vaccine is fully approved, it is expected to change, with a different formula or diluted version available for children. But it’s an obstacle now.
Another hurdle: the unique way in which Covid vaccines are delivered. They are still under the control of the federal government, which pays for them, so getting them on behalf of a hospital pharmacy or medical office is not as simple as asking a distributor of medical products for a delivery. The entities that issue the vaccines are signed commitments with the CDC being advanced on how they will deliver it. Violating that can have professional consequences. In fact, at the ACIP meeting on Monday, there was an unscheduled addition to the agenda: a brief speech by a CDC staffer who, without specifying which recipients he was referring to, warned that the use of branded vaccines could prevent providers from paying, make them legally liable for vaccine damage claims, and jeopardize their approval from the CDC to continue delivering the vaccine.