Off-Label Use of COVID Vaccines for Kids

Now that the Pfizer COVID vaccine is officially FDA approved, lots of folks are asking about the off-label use of this COVID vaccine for kids.

Of course, many of these parents are only interested because they want their kids vaccinated and protected, especially as COVID cases surge in their areas.

Off-Label Use of Vaccines

Providers often do prescribe treatments off-label – the use of an approved drug in an unapproved way to treat a disease or medical condition.

“From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient”
Understanding Unapproved Use of Approved Drugs “Off Label”

Just consider all of the folks prescribing hydroxycloroquine, ivermectim, and azithromycin, etc. to prevent and treat people with COVID. None are approved for COVID, most providers know they don’t work, but still, many other providers are prescribing them.

More often, the off-label use is for something much more beneficial, like treating a severe infection with an antibiotic that is only approved for adults or using a chemotherapy agent that is only approved for another type of cancer.

“Off label use may be inadvertent or intentional. Examples of off label use might include
use of a product in an age group outside the recommended age group or use in a population
for whom the vaccine is contraindicated. For example, administering live, attenuated
influenza vaccine (LAIV) to a person with asthma would be an off-label use.”
Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda: Draft Recommendations: Addendum on April 10, 2008

Interestingly, vaccines are even used off-label sometimes.