Now that the Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, that means it can legally be used off-label. The million-dollar question is should doctors prescribe it for young children for whom no COVID-19 vaccines are recommended?
There's a lot to unpack here, so let's begin with the FDA approval.
Pfizer COVID-19 Vaccine Gets Full FDA Approval
On Aug. 23, 2021, the FDA announced it approved the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 infection in people age 16 years and older. The vaccine will be marketed under the brand-name Comirnaty.
The vaccine has been administered to millions of Americans under the emergency use authorization (EUA). This designation, which has also been granted to COVID-19 vaccines manufactured by Moderna and Johnson & Johnson's Janssen Pharmaceuticals, enables the FDA to accelerate the review of medical countermeasures, such as vaccines, to make them available during public health emergencies, such as a global pandemic.
The Pfizer-BioNTech COVID-19 vaccine will continue to be administered to adolescents ages 12 through 15 under the EUA. No vaccine is currently recommended for children younger than 12.
Before a medication is approved, the manufacturer must submit clinical data and other information to the FDA for review showing that the drug is safe and effective for its intended uses. The approval of the Pfizer-BioNTech COVID-19 vaccine means the FDA has deemed that, despite any side effects, the benefits of the medication outweigh the risks.
What Is Off-label Use?
Doctors have the authority to prescribe an FDA-approved medication for unauthorized use — sometimes called off-label use — if they judge that it is medically appropriate for a particular patient. However, drug companies cannot market a medication for any use that the medication is not already approved for.
As many as 20 percent of all medications are prescribed for off-label use, including these FDA-approved drugs:
- Hypertension drug prazosin (brand name Minipress) is often used to treat nightmares related to post-traumatic stress disorder (PTSD).
- The female fertility drug clomiphene (brand name Clomid) is sometimes used to treat male infertility.
- The beta-blocker propranolol (brand name Inderal), used to treat hypertension, is occasionally used to treat anxiety.
Now that the Pfizer-BioNTech COVID-19 has been fully approved by the FDA, it can legally be prescribed off-label by physicians on a case-by-case basis. Considering that, as of the week ending Aug. 19, the AAP reported 180,000 new cases of COVID-19 among children and adolescents, and coupled with the fact that doctors are beginning to worry that the delta strain may be more dangerous to children, the question has been floated whether to vaccinate younger children, off-label.
Both the American Association of Pediatrics (AAP) and the FDA are warning against it.
And many doctors agree. "I support the AAP recommendation," Landon S. Combs, M.D., FAAP, BCCI, a pediatrician at Holston Valley Medical Center in Gray, Tennessee, says via email. "These types of decisions are made with the best interests of the patients and public in mind."
Why Not Give the Vaccine to Children Off-label?
One concern is that off-label prescribing has been linked to a higher rate of side effects — 44 percent greater compared to when medications are given for indications for which they are approved, according to a 2016 JAMA Internal Medicine study of 46,021 adults.
Another is that the dose of the adult vaccine is much higher than the doses being tested in children younger than 12, the AAP said in a statement. Health officials don't want children getting doses that are too large because it could expose them to more side effects. Nor do they want doctors trying to calculate what dose would be safe for young children.
Instead, says Yvonne Maldonado, M.D., FAAP, chair of the AAP Committee on Infectious Diseases, in the statement, "We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials."
Clinical trials for the COVID-19 vaccine in children younger than 12 are currently underway. In July, the FDA urged Pfizer-BioNTech and Moderna, makers of the two mRNA vaccines, to expand their clinical trials in children ages 5 to 11 to 3,000 children, according to The New York Times. Doing so will help uncover any side effects, such as a rare heart inflammation that's been seen in vaccinated people younger than 30.
"With the possibility of different ages requiring different dosages, waiting for the results of those studies before emergency authorization for use and/or approval for use is granted follows those tenets of making decisions based on the best interests of the patients and the public," Combs says. "We are all hoping for rapid but thorough research that will allow approval for all children as soon as possible to end this pandemic."
In the meantime, Combs recommends that patients continue to practice social distancing when and where possible, limit trips and exposure, continue with wearing masks for age-appropriate groups, taking appropriate measures to prevent spread (such as hand-washing and not touching one's own face or mask), and quarantining if they become ill with the virus.
"While we wait for a vaccine to be authorized for younger children, it's important that everyone who is eligible now get the vaccine," adds AAP President Lee Savio Beers, M.D., FAAP, in the statement. "That will help reduce the spread of the virus and protect those who are too young to be vaccinated."