Generic Paxlovid Coming to Low- and Middle-Income Countries

The Clinton Health Access Initiative (CHAI) recently announced agreements with leading manufacturers to produce generic Paxlovid available to low- and middle-income countries priced under $25 per treatment course.

Equitable access to effective oral antiviral medications, especially for high-risk populations, will help save lives and limit the impact of future COVID-19 surges. 

Under the agreements announced today, the companies will guarantee the production of an affordable generic version of Paxlovid and dedicate capacity for 4.5 million treatment courses per month for low- and middle-income countries covered under their licensing agreements with the Medicines Patents Pool, pending the provision of demand forecasts. 

Produced by Pfizer Inc., Paxlovid is one of two U.S. FDA Approved oral antivirals for use by people who are recently diagnosed with COVID-19. In the U.S., Paxlovid costs over $500 per course.

CHAI interim co-CEO Joy Phumaphi announced on May 12, 2022, in a press release, “Today’s agreements represent a significant step toward ensuring equitable access to a proven COVID-19 treatment that will save lives and reduce the burden on struggling health systems.”

Manufacturers will work to file for World Health Organization prequalification or approval from a Stringent Regulatory Authority by the first quarter of 2023 and will register the product widely across licensed territories. Participating companies are well-established and trusted suppliers to the U.S. President’s Emergency Plan for AIDS Relief program.

Paxlovid became the first orally administered coronavirus-specific investigational protease inhibitor authorized for certain adults and children by the U.S. FDA on December 22, 2021. 

Paxlovid works intracellularly by binding to the highly conserved main protease of the SARS-CoV-2 coronavirus. By inhibiting the main protease, Paxlovid inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication. 

Paxlovid is co-administrated with a low dose of ritonavir, a strong cytochrome P450 3A inhibitor, to slow the metabolism or breakdown of Paxlovid and to remain active in the body for more extended periods at higher concentrations to help combat the virus.

As of May 7, 2022, the U.S. HHS Office of the Assistant Secretary for Preparedness and Response had distributed about 2,492,645 Paxlovid oral treatments since late 2021.

To improve access to Covid-19 treatments, the U.S. administration recently launched the "Test to Treat" initiative with local pharmacies.

As of May 14, 2022, additional FDA-authorized oral and IV COVID-19 treatments are listed at CoronavirusToday.com/treatments.  

The CHAI is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries.

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