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 includeCenters for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda: Draft Recommendations: Addendum on April 10, 2008
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.”
Interestingly, vaccines are even used off-label sometimes.
Off-Label Use of COVID Vaccines for Kids
So what would keep a provider from giving a Pfizer COVID vaccine off-label, to a child who is under age 12 years of age?
For one thing, the Pfizer COVID vaccine is only FDA approved for individuals 16 years of age and older.
“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”FDA Approves First COVID-19 Vaccine
For younger kids, 12 to 15 years, it still has an emergency use authorization (EUA).
Anyway, off-label use of COVID vaccines is not authorized.
So your in addition to the CDC, FDA, and AAP, your pediatric provider will likely say no if you ask about off-label use of COVID vaccines for your younger kids.
More on COVID Vaccines for Kids
- Are COVID-19 Vaccine Manufacturers Exempt from Liability?
- Treating Kids with COVID Monoclonal Antibodies
- 7 Things to Know About COVID-19
- EUA vs Licensure of COVID Vaccines for Younger Kids
- COVID Vaccines for Children Should Get Emergency Use Authorization
- Kids and Young Adults Should Get a COVID-19 Vaccine
- Did the WHO Say That Children Should Not Be Vaccinated Against COVID?
- The Truth About COVID-19 Vaccines
- I’m Not Anti-Vaccine, I Just Don’t Believe in the COVID-19 Vaccine
- Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?
- FDA – Understanding Unapproved Use of Approved Drugs “Off Label”
- FDA – FDA Approves First COVID-19 Vaccine
- CDC – COVID-19 Vaccine FAQs for Healthcare Professionals
- AAP: Don’t use COVID-19 vaccine off-label for children
- American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12
- CDC: Clinicians administering COVID-19 vaccines off-label risk losing liability protection, payment
- AAP – Off-Label Use of Drugs in Children
- FDA approval of Pfizer COVID vaccine – why did it take so long?
- Off-label vaccines – An introductory guide for healthcare professionals
- Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda: Draft Recommendations: Addendum on April 10, 2008