FDA Announces Transition Plan for Paxlovid: Shift From Emergency Use to Approved Labeling

In December 2021, the FDA granted emergency use authorization (EUA) for Paxlovid, a treatment for individuals at high risk of severe COVID-19. In May 2023, the FDA approved Pfizer's new drug application (NDA) for Paxlovid to treat mild-to-moderate COVID-19 in high-risk adults. The latest update from the FDA involves a revision to the Paxlovid EUA, impacting its authorized use.

The FDA has declared that Paxlovid manufactured and labeled under the EUA (EUA-labeled Paxlovid) currently in distribution will remain authorized until its labeled or extended expiration date, or until March 8, 2024, whichever comes earlier. However, after March 8, 2024, EUA-labeled Paxlovid will no longer be authorized for emergency use, regardless of its expiration date.

“This revision to the Paxlovid EUA is the next phase in the transition from the use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid,” the press release noted. “This transition began on November 1, 2023, with the introduction of FDA-approved Paxlovid (NDA-labeled Paxlovid).”

The revised authorization emphasizes that the EUA will continue to authorize the emergency use of NDA-labeled Paxlovid for treating mild-to-moderate COVID-19 in high-risk pediatric patients aged 12 and older.

To ensure a seamless shift from the use of EUA-labeled Paxlovid to the FDA-approved NDA-labeled version, the FDA is providing information on the timing of the transition. Dispensing sites, such as pharmacies, are encouraged to transition to NDA-labeled Paxlovid to maintain its availability.

Pharmacies, pharmacists, and other healthcare providers can dispense unexpired EUA-labeled Paxlovid consistent with the EUA terms until March 8, 2024. Pfizer's website provides information on lots of EUA-labeled Paxlovid eligible for shelf-life extension. Any lots not listed on Pfizer's website should be used until the labeled expiration date or March 8, 2024, whichever is earlier.

Expired EUA-labeled Paxlovid must be returned or disposed of according to federal, state, and local regulations. After March 8, 2024, any remaining EUA-labeled Paxlovid in distribution must be returned or disposed of in compliance with regulations.

Patients with a Paxlovid prescription will receive either EUA-labeled or NDA-labeled Paxlovid through March 8, 2024. After this date, they will exclusively receive NDA-labeled Paxlovid. Patients with an EUA-labeled Paxlovid prescription on or before March 8, 2024, and who initiated treatment by that date, can complete their course of treatment beyond March 8, 2024.

Eligible patients can receive free Paxlovid through the PAXCESS program until December 31, 2024. This program benefits Medicare and Medicaid beneficiaries, uninsured individuals without a prescription drug benefit, and commercially insured patients eligible for copay savings. The FDA advises patients to consult their pharmacist for any questions about expiration dates and to check Pfizer's website for updates.