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The Secret To Vaccinating Children: Off-Label Vaccinations

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Jessica Flanigan | 9.1.2021 3:15 PM

With the Pfizer vaccine for COVID-19 granted full approval by the Food and Drug Administration (FDA) for use on anyone ages 13 and up, pediatricians can actually now legally give it to patients under 12 years old, even though the drug is not yet technically approved for this age group. This is because once a drug is FDA approved, physicians can legally prescribe drugs off-label, beyond the scope of the drugs' initial approval, if they judge that it is medically appropriate. Yet while some parents have successfully scheduled vaccines for their younger children, pediatric vaccination is likely to remain unavailable to most families even as children return to school in communities that are facing a resurgence of COVID-19 cases and pediatric hospitalizations are on the rise.

Pediatric vaccination is unlikely to become widely available for two reasons. First, FDA marketing restrictions prevent manufacturers from publicizing information about off-label vaccination for kids younger than 12. Second, public health authorities at the FDA and the Centers for Disease Control and Prevention (CDC) are discouraging off-label prescribing, citing a lack of data regarding the safety and efficacy of vaccines for younger patients, and many parents and providers follow the guidance of those officials.

So, in essence, public health officials are censoring the information that would help people make an informed choice, and then saying that parents and pediatricians can't make an informed choice because they don't have enough information about off-label pediatric vaccination.

Off-label prescribing is very common for kids, since many drugs are not approved for pediatric prescribing. Pediatricians know that "off label is not synonymous with off evidence" and it's often worth it for doctors, parents, and patients to choose to use a drug in ways that differ from its approved use. But the FDA prohibits any drug marketing except for........

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