Since this article was first published, both the FDA and the American Academy of Pediatrics have issued strong statements against using the Pfizer vaccine off-label in children under 12. Acting FDA Commissioner Janet Woodcock called the issue a "matter of great concern." The AAP’s position has shifted from earlier support for approval based on existing data, which makes off-label use in this age group less likely and more controversial. In contrast, booster shots for vaccinated adults appear to be less contentious.

With the FDA expected to fully approve the Pfizer COVID-19 vaccine today, one key implication has been overlooked: full approval will legally allow off-label use. While the news is being celebrated for its potential to boost public confidence, it also opens the door for doctors to prescribe additional doses before formal approval for those uses.

Previously, the Pfizer vaccine operated under an Emergency Use Authorization (EUA), which limited how and when it could be used. Now, with full approval, the FDA will define “on-label” uses, but doctors can still prescribe the vaccine in other ways—known as “off-label” use. This is common practice in medicine, with about one in five prescriptions being off-label. For example, a drug approved for epilepsy may be prescribed for migraines.

Starting Monday, doctors will be legally allowed to prescribe the Pfizer vaccine for:

• Children
• Third doses for adults
• Boosters for people who received the Johnson & Johnson or other vaccines
• Adaptive dosing based on antibody levels
• Other uses not yet anticipated

This could mean that people might get vaccinated for these purposes before they are officially approved. Third doses for adults are expected to start in late September, even though data shows waning immunity after just five months. Meanwhile, pediatric doses may not be approved until October, despite schools already starting up.

To access the vaccine off-label, individuals would need a doctor’s prescription and a pharmacy willing to fill it. While more Pfizer doses are arriving at primary care clinics, it's unclear when this will happen. It's also uncertain whether major pharmacies will accept off-label prescriptions—but I suspect many will.

As a result, it's unclear whether off-label use will be widespread or rare, or whether it will spark debate or go largely unnoticed. We’ll be keeping a close eye on developments following today’s approval and will update you as things unfold.

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