Important Information About Paxlovid
Paxlovid (nirmatrelvir co-packaged with ritonavir) is an oral antiviral drug that should be initiated as soon as possible within 5 days of symptom onset. Paxlovid is available for patients by prescription only. Prescriptions can be obtained from your health care provider or through the
Test to Treat program.
On May 25, 2023, the U.S. Food and Drug Administration (FDA) approved Pfizer’s application for Paxlovid to treat adults (18 years of age and older) with a current diagnosis of mild to moderate COVID-19 and who are at high risk for progression to severe COVID-19. At the same time, FDA retained Emergency Use Authorization (EUA) for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild to moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Please see the
Eligibility Screening Checklist for additional details.
Paxlovid is available in two package presentations:
- Paxlovid Standard Dose that includes 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days.
- Paxlovid Reduced Dose is for people with moderate renal impairment (eGFR ≥ 30 mL/min to < 60 mL/min) that includes 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days. Paxlovid is not recommended for people with severe renal impairment (eGFR < 30 mL/min).
Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. There are known drug interactions with Paxlovid. See the
Drug Interaction Checker for more information.
For information on returning undispensed, USG distributed, EUA-labeled supply, please see
Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program.
Emergency Use Authorization and Approval of Paxlovid
On May 25, 2023, Paxlovid received approval to treat adults with mild to moderate COVID-19 in eligible patients and retained the EUA for these patients as well as for children ages 12 and older weighing at least 40 kg (88 pounds).
On January 29, 2024, the Food and Drug Administration (FDA)
announced an important revision to the Paxlovid emergency use authorization (EUA), stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier.
As of March 9, 2024, EUA-labeled Paxlovid (nirmatrelvir co-packaged with ritonavir) no longer authorized for use, regardless of expiry data.
Paxlovid received initial EUA on December 22, 2021, for the treatment of mild to moderate COVID-19 in eligible patients.
The
FDA website hosts the latest information on the EUA.
Distribution of Paxlovid
From December 2021 to December 15, 2023, the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) worked with jurisdiction health departments, pharmacy partners, Test to Treat sites, long-term care providers, and health centers funded by the Health Resources and Services Administration (HRSA) to support the fair and equitable distribution of Paxlovid. The medication with the EUA label was provided for free by the U.S. government (USG) through December 15, 2023. It is now available through commercial distribution.
Jurisdiction health departments, pharmacy partners, and other central partners assisted with distribution of the product to dispensing sites across the nation, and the distributor shipped product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.
Continued Access to the U.S. Government Paxlovid Supply
With the transition to traditional commercial ordering and distribution of Paxlovid HHS continues to leverage USG-procured supply of Paxlovid to ensure affordable access for all patients, including no cost access for beneficiaries of public programs such as Medicare and Medicaid and for those who are uninsured. HHS took steps to ensure procured product is not lost to expiry and established a separate stockpile for future emergencies.
U.S. Government Patient Assistance Program Operated by Pfizer
Through December 31, 2024, individuals covered under federal programs, such as Medicare or Medicaid, and uninsured patients are eligible for the USG Patient Assistance Program (PAP) operated by Pfizer and can receive Paxlovid at no cost. Patients or health care providers and pharmacists on behalf of patients can enroll to participate in the program at
https://paxlovid.iassist.com. This program is supported by USG-procured Paxlovid.
Retail pharmacies can learn more about becoming a Paxlovid PAP participating location by contacting the program vendor at
PharmacyNetworkContract102101@assistrx.com.
Federal Entities Authorized to Distribute Paxlovid
Certain federal entities (HRSA-supported health centers, Indian Health Service health centers, Veterans Health Administration facilities, Department of Defense, and others) continue to have access to remaining USG-procured Paxlovid supply for patient care. USG-procured Paxlovid also may be used to support state, local, tribal, or territorial special programs targeting vulnerable populations on a case-by-case basis.
Paxlovid Co-Pay Savings Program
Pfizer is separately operating a
Paxlovid Co-Pay Savings Program for eligible privately (commercially) insured patients to ensure affordable access. Health care providers and pharmacists can enroll their patients at
Paxlovid.pfizerpro.com.
Paxlovid FDA Resources
