When Pfizer’s COVID-19 vaccine was approved in August, it was only approved for ages 16 and up as a two-dose series. But since fully-approved vaccines and medications can be used “off label,” many of us started wondering if providers could administer the vaccine to children or give boosters to people who wouldn’t otherwise qualify for them. Unfortunately, that’s not likely to be the case. The reason relates to some specific government paperwork, but first let’s talk about what “off label” means.
What does “off label” mean?
Drugs (and vaccines) are FDA approved for specific purposes. But providers are allowed to use their judgment in deciding when and how to prescribe something. For example, a chemotherapy drug might be approved for one type of cancer, but prescribed for a different type of cancer. That’s one of the examples the FDA gives in their explainer of off-label use; maybe there is no approved drug for your condition, or maybe you’ve tried the approved drugs and they haven’t worked.
So, in theory, a provider might be able to administer a vaccine to an age group or for a purpose that it’s not approved for. This wouldn’t be recommended, but it would be legal.
Why the COVID vaccine is different
The way COVID vaccines are being distributed in the U.S. is different than most vaccines or medications. All doses of the vaccines were actually purchased by the federal government, rather than ordered by providers directly. Providers have to agree to the terms of the CDC COVID-19 Vaccination Program, which includes only administering the vaccines as recommended.
If a provider were to give the vaccine off label anyway, they might be kicked out of the program and be unable to administer future doses of the vaccine. They also might not be covered under the Public Readiness and Emergency Preparedness Act (PREP Act), which provides immunity from liability if anything were to go wrong.
There are also downsides from the patient’s point of view, as the CDC explains here. For one, insurance may not pay for the vaccine’s administration fee, leaving patients or parents with the bill. And if the person who receives the vaccine were to have any adverse events caused by the vaccine, they wouldn’t be eligible for compensation like they would for other vaccine injuries.
The American Academy of Pediatrics also advises against off-label use for children, noting that the doses being tested in vaccine trials for children are different from the adult vaccine, and that we don’t yet have enough information on the safety of the vaccine in children. Pfizer says they expect to apply for emergency authorization for ages 5 to 11 by the end of September, so we may not have long to wait. And if you’re hoping for a booster for yourself, those could start coming (legally) as soon as Sept. 20, so just sit tight.