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A difficult reality, however, is that many drugs are already used off-label in children; Prior to 2003, when legislation changed the authorization rules, there was no requirement that drugs be tested in children before they were prescribed. A 2019 study found that doctors used off-label medicines for children on nearly one in five outpatient visits, most often antibiotics, although other classes were also prescribed off-label. Such frequent use poses challenges for doctors and pharmacists under pressure to prove that Covid is different.
“In other cases of off-label prescription of drugs approved for adults, pediatric use occurs very gradually, usually one case at a time, until there is a sufficient knowledge base to stop or expand use in children, ”Shannon Manzi, an assistant professor of pediatrics and director of safety and quality in the Harvard Medical School’s department of pharmacy, told WIRED via email. “If several thousand children receive the vaccine at the same time, without having the time to sufficiently examine the data from vaccine manufacturers’ trials in children, we have lost this ability to ensure efficacy and to detect any problems beforehand. that it does not reach the general population. “
Yet, Manzi wrote, pharmacists are already feeling pressure to dispense 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 struck up a conversation and made sure we were going to be united on it,” she said. “The feeling I’ve heard from everyone I’ve spoken to is that we feel the pressure, but we don’t feel comfortable expanding what has been approved and going down below. 12 years old. Because we are still in the midst of pediatric studies to determine the best dose.
The Pfizer trial design divides children under 12 into three age groups – 6 to 23 months, 2 to just under 5, then 5 to 11 – and assigns a different dose to each group based on their average age, size, and likely immune system maturity. These doses have been made public, and in some of the social gossip over the past week, clinicians posted them again, as a protection against anyone trying to use the off-label vaccine is making a mistake. “The first thing is to make sure they are using the right dose, because if you use the adult dose, people will have too many side effects,” says David Boulware, adult infectious disease physician and professor at the University of Minnesota School of Medicine. “I hope that if people use the vaccine off-label, they will use the same dose being studied in phase III pediatric trials.”
Obtaining the off-label vaccine may not be as easy as it sounds. On the one hand, the doses for children are tiny, as low as 3 micrograms. This strength is not individually prepackaged; it must be drawn up from a vial. Working ad hoc from the vaccine vials currently in use, it would be easy to get inaccurate and overdose, says Michael Ganio, senior director of pharmacy practice and quality at the American Society. of Health-System Pharmacists. Once the vaccine is fully approved, that should change, with a different formula or a diluted version available for children. But it’s an obstacle now.
Another obstacle: the unique way in which the Covid vaccines are distributed. They are still under the control of the federal government, which pays for them, so obtaining them on behalf of a hospital pharmacy or doctor’s office is not as easy as requesting delivery from a distributor of medical products. The entities that distribute the vaccines have signed commitments with the CDC in advance on how they will distribute them. Breaking them could have professional repercussions. In fact, at Monday’s ACIP meeting, there was an unexpected addition to the agenda: a brief intervention from a CDC staff member who, without specifying which recipients he was talking about, warned that the Use of the vaccine off-label could prevent providers from being reimbursed, make them legally liable for vaccine injury claims, and jeopardize their CDC authorization to continue delivering the vaccine.
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