However, a difficult reality is that many drugs have been used beyond the instructions in children. Before 2003, when the legislation Changed the permission rules, There is no requirement to test drugs for children before they are prescribed.A sort of Study in 2019 It was found that doctors used off-label drugs for children in almost one-fifth of outpatient visits, the most common being antibiotics, although other categories were also prescribed off-label. Such frequent use poses challenges for doctors and pharmacists who are facing the pressure to prove Covid is different.
“In other cases where adult drugs are approved for off-label prescriptions, pediatric use occurs gradually, usually one case at a time is reported until there is a sufficient knowledge base to stop or expand the use of children,” Shannon Manz, Harvard Medical School Pharmacy The assistant professor of pediatrics and the director of safety and quality told Wired magazine via email. “If thousands of children are vaccinated at the same time, and there is no time to fully review the data of the vaccine manufacturer’s trials in children, we will lose the ability to ensure the effectiveness of the vaccine and find any problems before it reaches the general population. .”
However, Manz wrote, pharmacists have felt the pressure to distribute vaccines. Ashley Duty, the pharmacy manager at Children’s Charity Hospital in Kansas City, Missouri, said the same. “When we heard that the FDA would approve Pfizer’s vaccine, our team started a conversation and made sure we were united in this matter,” she said. “The emotion I hear from everyone I have spoken to is that we do feel the pressure-but we are uncomfortable with expanding the approved content and being under the age of 12. Because we are still in the middle stage of pediatric research To determine the best dose.”
Pfizer’s trial design divided children under 12 years of age into three age groups—6 to 23 months, 2 to 5 years old, and then 5 to 11 years old—and based on their average age, body size, and their The immune system may be mature.These dosages have been made public, and in some social discussions last week, clinicians Post them again, As a hedge against mistakes made by anyone who tries to use off-label vaccines. “The first thing is to make sure they use the correct dose, because if you use an adult dose, people will have too many side effects,” said David Bolwell, an adult infectious disease doctor and a professor at the University of Minnesota School of Medicine. “Hopefully, if people use an off-label vaccine, they will use the same dose studied in the phase III pediatric trial.”
Obtaining an off-label vaccine may not be as easy as it sounds.On the one hand, the child dose is Tiny, As low as 3 micrograms. The dose is not individually prepackaged; it must be extracted from the vial. Michael Ganio, senior director of pharmacy practice and quality at the American Health System Pharmacists Association, said that temporary work based on currently used vaccine vials can easily produce inaccurate and excessive doses. Once the vaccine is fully approved, this situation is expected to change, providing children with different formulas or diluted versions. But this is now an obstacle.
Another obstacle: the unique way of distributing the Covid vaccine. They are still controlled by the federal government, which pays for them, so obtaining them on behalf of a hospital pharmacy or medical office is not as simple as asking a medical product distributor to deliver them.Signed by the entity distributing the vaccine promise Check with CDC in advance to find out how they will distribute them. Breaking these can have a professional impact. In fact, during the ACIP meeting on Monday, an unscheduled item was added to the agenda: a brief conversation with CDC staff, who did not specify which recipients he was discussing, warning that the use of off-label vaccines might deter providers Obtaining reimbursement places them legally responsible for vaccine injury claims and jeopardizes CDC’s permission to continue to provide vaccines.