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When Pfizer’s COVID-19 vaccine was approved in August, it was only approved as a two-dose series for children aged 16 and over. However, because fully approved vaccines and drugs can be used “off-label”, many of us wondered whether providers could give the vaccine to children or give a booster to people who were otherwise out of the question. Unfortunately, that’s probably not the case. The reason relates to some specific government papers, but first let’s talk about what “off-label” means.
What does “off-label” mean?
Drugs (and vaccines) are approved by the FDA for specific purposes. But providers are allowed to use their judgment to decide when and how to prescribe something. For example, a chemotherapy drug may be approved for one type of cancer but prescribed for another type of cancer. This is one of the examples the FDA cites your explainer of off-label use; Perhaps there isn’t an approved drug for your condition, or you tried the approved drugs and they didn’t work.
So, in theory, a provider could give a vaccine to an age group or for a purpose for which it is not approved. That would not be recommended, but it would be legal.
Why the COVID vaccine is different
The way COVID vaccines are distributed in the US is different from most vaccines or drugs. All doses of the vaccines were actually purchased from the federal government and not ordered directly from the vendors. Providers must comply with the terms of the CDC COVID-19 vaccination programwhich only involves administering the vaccines as recommended.
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If a provider were to off-label the vaccine anyway, they could be kicked out of the program and unable to deliver future doses of the vaccine. They may also not fall under the Public Standby and Emergency Preparedness Act (PREP Act)that provides immunity from liability in the event that something should go wrong.
There are also disadvantages from the patient’s point of view, as the CDC explains here. For one thing, the insurance company may not pay the vaccine administration fee, so patients or parents will have to take this into account. And if the person receiving the vaccine has side effects caused by the vaccine, they are not eligible for compensation like they are for other vaccination violations.
the The American Academy of Pediatrics also advises against off-label use for children, notes that the doses being tested in childhood vaccine trials are different from those of the adult vaccine and that we do not yet have enough information on the safety of the vaccine in children. Pfizer says they are expected to apply for an emergency permit for ages 5-11 by the end of September so we may not have to wait long. And if you’re hoping for a booster for yourself, that could (legally) come as early as September 20th, so just stay seated.