FDA guides the transition from emergency-use-labeled Paxlovid to approved labeling, impacting dispensing sites, providers, and patients.
FDA sign outside the building.
(Adobe Stock 323811316 by JHVEphoto)
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.
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
Reducing Hidden Risks: Why Sharps Injuries Still Go Unreported
July 18th 2025Despite being a well-known occupational hazard, sharps injuries continue to occur in health care facilities and are often underreported, underestimated, and inadequately addressed. A recent interview with sharps safety advocate Amanda Heitman, BSN, RN, CNOR, a perioperative educational consultant, reveals why change is overdue and what new tools and guidance can help.
New Study Explores Oral Vancomycin to Prevent C difficile Recurrence, But Questions Remain
July 17th 2025A new clinical trial explores the use of low-dose oral vancomycin to prevent Clostridioides difficile recurrence in high-risk patients taking antibiotics. While the data suggest a possible benefit, the findings stop short of statistical significance and raise red flags about vancomycin-resistant Enterococcus (VRE), underscoring the delicate balance between prevention and antimicrobial stewardship.
What Lies Beneath: Why Borescopes Are Essential for Verifying Surgical Instrument Cleanliness
July 16th 2025Despite their smooth, polished exteriors, surgical instruments often harbor dangerous contaminants deep inside their lumens. At the HSPA25 and APIC25 conferences, Cori L. Ofstead, MSPH, and her colleagues revealed why borescopes are an indispensable tool for sterile processing teams, offering the only reliable way to verify internal cleanliness and improve sterile processing effectiveness to prevent patient harm.
The Next Frontier in Infection Control: AI-Driven Operating Rooms
Published: July 15th 2025 | Updated: July 15th 2025Discover how AI-powered sensors, smart surveillance, and advanced analytics are revolutionizing infection prevention in the OR. Herman DeBoard, PhD, discusses how these technologies safeguard sterile fields, reduce SSIs, and help hospitals balance operational efficiency with patient safety.
Targeting Uncertainty: Why Pregnancy May Be the Best Time to Build Vaccine Confidence
July 15th 2025New national survey data reveal high uncertainty among pregnant individuals—especially first-time parents—about vaccinating their future children, underscoring the value of proactive engagement to strengthen infection prevention.