Taking PAXLOVID® (nirmatrelvir tablets and ritonavir tablets) from the Lab to Patients to Combat COVID–19

Pfizer is working to enable broad access to PAXLOVID worldwide and evaluate the treatment for more who may benefit.

PAXLOVID as a tool in the fight against COVID-19

As COVID-19 continues to evolve, PAXLOVID (nirmatrelvir tablets and ritonavir tablets) has shown to be an important complementary tool to vaccination strategies for the estimated 40% of the global adult population at high risk for progressing to severe disease.1 PAXLOVID has shown efficacy, a consistent safety profile, and the potential to help mitigate the financial burden of COVID-19 on patients and their families, health systems, and society.2,3

As societies grapple with how to live with COVID-19, efforts to reduce the ongoing impact are vital to managing the pandemic over the long term and transforming it into a manageable, endemic disease. In January 2022, Pfizer announced an agreement that provided the U.S. government with 20 million PAXLOVID treatment courses in 2022,4 and in December announced an additional 3.7 million treatment courses to be provided by early 2023.5 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recognized the potential value of PAXLOVID, granting a conditional marketing authorization. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.6

Pfizer’s Commitment to Access

Pfizer has continued to look for opportunities to partner with global health leaders to expand access to PAXLOVID. As of December 31, 2022, Pfizer has shipped 39 million treatment courses to 60 countries around the world*, continuously working with the World Health Organization-led COVID-19 Tools Accelerator (ACT-A) partners to enable supply to low- and middle-income countries. This includes an agreement with UNICEF for up to 4 million treatment courses for 137 countries and an agreement with Global Fund for up to 6 million treatment courses for 132 countries, subject to local regulatory approval or authorization.7,8 Pfizer also launched ‘An Accord for a Healthier World’ to support worldwide access to PAXLOVID, as well as other Pfizer medicines and vaccines, on a not-for-profit basis to 45 lower-income countries.9 Because product supply is only one step towards improving access, and treatment with PAXLOVID requires a positive COVID-19 test within five days of symptom onset, Pfizer has also joined the Quick Start consortium, an initiative led by Duke University, the Clinton Health Access Initiative (CHAI), COVID Collaborative, and Americares that is focused on rapid scale-up of test and treat capabilities in under-resourced countries.10 Pfizer is providing donated product and financial support for pilots in 10 countries in Africa and Southeast Asia.

“We are dedicated to helping ensure that everyone at increased risk for becoming seriously ill, no matter where they live, has access to this important treatment option,” said JoyL Silva, U.S. Commercial and Global Business Lead, Antivirals.

To further expand access to oral treatment worldwide, Pfizer signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to facilitate the production and distribution of generic versions of the oral treatment for supply to 95 low- and middle-income countries. MPP has sub-licensed to 37 generic manufacturers who will produce low-cost, generic versions that will be available to approximately 53% of the world’s population, subject to local regulatory approval or authorization.11

The Future of PAXLOVID

In parallel to expanding access in 2022, Pfizer progressed the PAXLOVID clinical development program, continuing to explore opportunities to evaluate its potential in vulnerable populations, including children and those who are immunocompromised and for long COVID. A New Drug Application (NDA) to the U.S. Food and Drug Administration for PAXLOVID for patients who are at high risk for progression to severe illness from COVID-19 is under review.

A worker packs PAXLOVID to be distributed

Packing PAXLOVID to be distributed.

As COVID-19 evolves,12 we will continue aiming to stay ahead of the virus, advancing promising science with a multi-pronged strategy that we believe will help serve patients in need. We’re proud of the hard work of our colleagues that has contributed to our progress in combatting the virus, and we remain steadfast in these efforts as we prepare for what’s ahead.

PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an 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.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b) (1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

* This figure includes treatment courses distributed to customers as well as those stored and ready for distribution.

  1. Clark A, Jit M, Warren-Gash C, et al. Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health conditions in 2020: A modelling study. The Lancet Global Health. 2020;8(8):1003-1017. doi:10.1016/s2214-109x(20)30264-3
  2. Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death. (2021, December 14). Pfizer. Retrieved November 1, 2022, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results.
  3. Rickard Sandin, Cale Harrison, Florin Draica et al. Estimated Impact of Oral Nirmatrelvir;Ritonavir on Reductions in Hospitalizations and Associated Costs within High-Risk COVID-19 Patients in the US, 30 November 2022, PREPRINT (Version 1) available at Research Square https://doi.org/10.21203/rs.3.rs-2191067/v1(link is external).
  4. Pfizer to Provide U.S. Government with an Additional 10 Million Treatment Courses of its Oral Therapy to Help Combat COVID-19. (2022, January 4). Pfizer. Retrieved October 27, 2022, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provide-us-government-additional-10-million.
  5. Pfizer to provide U.S. government with an additional 3.7 million treatment courses of PAXLOVIDTM to help combat covid-19. Pfizer. (2022, December 13). Retrieved December 20, 2022, from https://www.pfizer.com/news/announcements/pfizer-provide-us-government-additional-37-million-treatment-courses-paxlovidtm
  6. Covid-19: EMA recommends conditional marketing authorisation for Paxlovid. European Medicines Agency. (2022, January 28). Retrieved October 31, 2022, from https://www.ema.europa.eu/en/news/covid-19-ema-recommends-conditional-marketing-authorisation-paxlovid(link is external)
  7. UNICEF signs supply agreement with Pfizer for oral COVID-19 treatment. (2022, March 22). UNICEF. Retrieved October 27, 2022, from https://www.unicef.org/liberia/press-releases/unicef-signs-supply-agreement-pfizer-oral-covid-19-treatment(link is external).
  8. The Global Fund Signs Agreement with Pfizer to Expand Access to PAXLOVIDTM Antiviral. (2022, September 22). The Global Fund. Retrieved October 27, 2022, from https://www.theglobalfund.org/en/news/2022/2022-09-22-the-global-fund-signs-agreement-with-pfizer-to-expand-access-to-paxlovid-antiviral/(link is external).
  9. Covid Treatment Quick Start Consortium. COVID Collaborative. (2022, September 7). Retrieved October 31, 2022, from https://www.covidcollaborative.us/initiatives/quickstart-consortium#:~:text=%E2%80%9CThe%20Quick%20Start%20Consortium%20is,as%20the%20subvariant%20Omicron%20BA(link is external).
  10. Covid Treatment Quick Start Consortium. COVID Collaborative. (2022, September 7). Retrieved October 31, 2022, from https://www.covidcollaborative.us/initiatives/quickstart-consortium#:~:text=%E2%80%9CThe%20Quick%20Start%20Consortium%20is,as%20the%20subvariant%20Omicron%20BA(link is external).
  11. 35 generic manufacturers sign agreements with MPP to produce low-cost, generic versions of Pfizer's oral covid-19 treatment nirmatrelvir in combination with ritonavir for supply in 95 low- and middle-income countries. Medicines Patent Pool. (2022, March 17). Retrieved October 31, 2022, from https://medicinespatentpool.org/news-publications-post/35-generic-manufacturers-sign-agreements-with-mpp-to-produce-low-cost-generic-versions-of-pfizers-oral-covid-19-treatment-nirmatrelvir-in-combination-with-ritonavir-for-supply-in-95-low-and(link is external)
  12. COVID-19 Dashboard. World Health Organization. Retrieved January 24, 2023, from https://covid19.who.int/(link is external).