Since the publication of this article, both the FDA and the American Academy of Pediatrics have issued strong warnings 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 recent stance came as a surprise, especially since it had previously supported the approval of the vaccine for kids based on existing data. This shift may make off-label use in this age group rare or highly controversial. In contrast, off-label booster doses for vaccinated adults are less likely to spark debate.

 

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

Until now, the Pfizer vaccine was only available under an Emergency Use Authorization (EUA), which strictly limited its use. Full approval changes that dynamic. While the FDA will still define what is “on label,” it will be legal for physicians to prescribe the vaccine in other ways—known as “off-label” use. Off-label prescriptions are common, with about one in five prescriptions nationwide falling into this category. For example, a medication approved for epilepsy might be prescribed off-label for migraines.

This means that starting Monday, doctors will be able to legally prescribe the Pfizer vaccine for:

• Children under 12
• Third doses for adults
• Boosters for people who received the Johnson & Johnson or other vaccines
• Adaptive dosing based on antibody levels
• Other unanticipated scenarios

This could allow people to access the vaccine for these purposes before they are officially approved. Third doses for adults are expected to be rolled out in late September, but only after eight months from the second dose, despite evidence from Israel showing waning immunity after just five months. Meanwhile, pediatric dosing is not expected to be approved until October, even though schools are already back in session. The American Academy of Pediatrics has urged the FDA to act on the data it already has.

To get the vaccine off-label, individuals would need a doctor’s prescription and a pharmacy willing to fill it. While the arrival of more Pfizer doses at primary care clinics may help, it’s unclear when that will happen. It’s also uncertain whether major pharmacies will accept off-label prescriptions—but I suspect they will.

As a result, it’s unclear how widespread or controversial off-label use of the Pfizer vaccine will become. Will it be a slow trickle or a sudden flood? And will it generate significant public debate or pass quietly under the radar? We’ll be keeping a close eye on developments following full approval and will update you as things evolve.

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