Why Is Your Doctor Reluctant to Give You an Unlabelled COVID Vaccine?
When Pfizer’s COVID-19 vaccine was approved in August, it was only approved for children aged 16 and over in a two-dose series. But because fully approved vaccines and drugs can be misused, many of us began to wonder if vaccine providers could give the vaccine to children or give boosters to people who would not otherwise be eligible for them. Unfortunately, this is not so. The reason has to do with some specific government documents, but first, let’s talk about what it means “off-label”.
What do you mean “off label”?
Medicines (and vaccines) are approved by the FDA for specific purposes. But service providers are allowed to use their judgment in deciding 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 example that the FDA cites in its explanation of off-label use ; maybe there is no approved drug for your condition, or maybe you tried approved drugs but they didn’t work.
So, in theory, a provider might be able to administer the vaccine to an age group or for a purpose for which it is not approved. This is not recommended but would be legal.
How the vaccine differs from COVID
COVID vaccines are distributed differently in the US than most vaccines or drugs. All doses of vaccines were actually purchased by the federal government, not directly ordered from suppliers. Providers must agree to the terms of the CDC COVID-19 Vaccine Program , which only includes administering the vaccine as recommended.
If the provider still mis-prescribes the vaccine, they may be dropped from the program and not be able to administer new doses of the vaccine. They also can not be subject to the Law on public preparedness and emergency preparedness (the PREP Act) , which provides immunity from liability if something goes wrong.
There are also downsides from the patient’s perspective , the CDC explains . First, insurance may not pay the vaccine administration fees, leaving patients or parents behind. And if the person who receives the vaccine has any side effects caused by the vaccine, they will not be eligible for compensation, as would be the case for other injuries caused by the vaccine.
The American Academy of Pediatrics also discourages the misuse of children , noting that the doses tested in the pediatric vaccine trials differ from the adult vaccine doses, and that we do not yet have sufficient information on the safety of the vaccine for children. children. Pfizer says it expects to apply for an emergency permit for children 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, they might start doing (legally) as early as September 20th , so just sit still.