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Wired: Are Off-Label Prescriptions a Backdoor to Giving Kids COVID Vaccines?

Children's Mercy vaccine clinic

By Maryn McKenna

The Food and Drug Administration’s decision to give full approval to the Pfizer Covid vaccine was only a few hours old last week when groups on Facebook lit up with questions.

But that was only for people 16 years old and up. For teens 12 to 15, the FDA left the Pfizer formula under emergency authorization. For children younger than 12, it kept the vaccine entirely off-limits until the conclusion of kids’ clinical trials, which are now due sometime in late fall. That immediately ignited debate among parents about whether they could find a way to get younger kids the shot, as well as whether they should.

Parents weren’t the only ones talking. Online circles of physicians and scientists fired up just as fast, arguing the ethics of administering the vaccine outside the bounds of the approval—through a process called “off-label” prescribing—versus waiting for data and for the FDA to rule.

Pharmacists are already feeling pressure to dispense 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 was going to approve the Pfizer vaccine, our team started a conversation and made sure we were going to be united on this,” she said. “The sentiment I’ve heard from everyone I have talked to is that we do feel the pressure—but we don't feel comfortable expanding upon what was approved and going any lower than age 12. Because we're still in the middle of the pediatric studies to determine the best dose.”


Read the full article via Wired

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