FDA Revises Emergency Use of Paxlovid

The revision is a step toward finalizing the transition from Paxlovid’s emergency use authorization to its new drug application label, initiated in late 2023.

Pfizer's Paxlovid in a file photograph. Wolfgang Rattay/Reuters/Illustration

The U.S. Food and Drug Administration (FDA) stated in a revised emergency use authorization that Paxlovid sold in the United States is authorized for use only through March 8, 2024, or the extended expiration date stamped on the medication’s label.

Paxlovid is an antiviral medication prescribed to patients to treat mild-to-moderate symptoms of COVID-19. It is approved for use in individuals 12 and older who weigh at least 88 pounds and who are considered at high risk of the disease worsening, such as hospitalization or death. These people may include those with cancer, chronic diseases, weakened immune systems, and obesity. The drug has been used since 2021 under emergency use authorization (EUA).

The revision was announced on Monday as a step toward finalizing the transition from Paxlovid’s emergency use authorization to its new drug application (NDA) label, which began on Nov. 1, 2023.

Pharmacies with EUA-labeled Paxlovid are to return expired boxes of the medication to the manufacturer or dispose of it in accordance with federal, state, and local regulations. All remaining EUA-labeled Paxlovid in the United States after March 8 must be returned to the manufacturer or similarly destroyed or disposed of per regulations.

It is unknown how much money expiration dates could cost the U.S. health care system, but the Financial Times reported that Paxlovid expiration dates could cost European health systems upward of $2.2 billion. The Financial Times reported that 3.1 million doses are set to expire by the end of February, which could cost European governments billions. The United Kingdom is set to suffer the biggest loss, with $700 million worth of doses having expired in December 2023, according to disease forecasting company Airfinity.

How the Update Affects COVID Patients

Patients shouldn’t expect to feel an impact, the FDA noted in its updated use authorization.

Patients prescribed Paxlovid will continue to receive either an EUA-labeled or NDA-labeled version through March 8. After that date, patients will only receive NDA-labeled Paxlovid.

Any patient who received EUA-labeled Paxlovid on or before March 8 should complete their treatment, even if treatment is slated to end after March 8, the FDA said. Any patient with questions about the expiration date on the box should talk to their pharmacist.

“Thus, during the period of transition, either NDA-labeled or EUA-labeled Paxlovid can be used for the treatment of both adults and adolescents consistent with the approved and authorized labeling as appropriate,” the FDA wrote in an FAQ document.

The FDA approved Pfizer’s NDA for Paxlovid on May 25, 2023, to treat mild-to-moderate COVID-19 symptoms in adults. In late October, Pfizer announced the label of the medication changed in accordance with NDA packaging requirements. Following the repackaging, the FDA revised its original EUA so that the new NDA Paxlovid—formulated identically to EUA Paxlovid—could be prescribed to children 12 and older.

Paxlovid has been available on the commercial market since Dec. 15, 2023, but it comes at a hefty price of $1,390 per five-day treatment. The medication was free for patients when the federal government contracted Pfizer for its distribution.

To help combat the high cost of the drug, certain patients are eligible for free Paxlovid through the PAXCESS program. Eligible patients include Medicare and Medicaid beneficiaries and uninsured individuals who do not have a prescription drug benefit when they fill their prescriptions. Some patients with commercial insurance may also be eligible for assistance through a co-pay savings program.