Pfizer's COVID-19 Treatment Paxlovid Will No Longer Be Available For Emergency Use After This Date, FDA Revises Label

The FDA has updated the emergency use authorization (EUA) for Pfizer Inc’s PFE Paxlovid, impacting its distribution and use in treating mild-to-moderate COVID-19. 

In December 2021, the FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients who are at high risk for progression to severe COVID-19, including hospitalization or death. 

In May 2023, the FDA approved Pfizer’s NDA for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

According to the revised authorization, EUA-labeled Paxlovid currently in distribution will remain authorized through its labeled or extended expiration date or until March 8, 2024, whichever is earlier.

However, post-March 8, 2024, EUA-labeled Paxlovid will no longer be authorized for emergency use, the FDA said. 

The transition aims to facilitate the shift to FDA-approved Paxlovid (New Drug Application (NDA)-labeled Paxlovid), which began on November 1, 2023.

The impact of this transition extends to pharmacies, pharmacists, and other healthcare providers. Until March 8, 2024, unexpired EUA-labeled Paxlovid can be dispensed, adhering to the EUA terms and conditions. Dispensing sites yet to transition to NDA-labeled Paxlovid are encouraged to do so to ensure uninterrupted availability.

Providers and patients are directed to Pfizer’s website for information on EUA-labeled Paxlovid shelf-life extensions. 

After March 8, 2024, all expired EUA-labeled Paxlovid must be returned or disposed of following federal, state, and local regulations.

Patients with Paxlovid prescriptions will receive either EUA-labeled or NDA-labeled Paxlovid until March 8, 2024, after which only NDA-labeled Paxlovid will be provided. 

Patients prescribed EUA-labeled Paxlovid before March 8, 2024, can complete their treatment even if it extends beyond that date.

For eligible patients, the PAXCESS program offers free Paxlovid until December 31, 2024, covering Medicare and Medicaid beneficiaries, uninsured individuals, and commercially insured patients with a co-pay savings program.

Price Action: PFE shares are down 0.04% at $27.46 on the last check Monday.

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