Paxlovid in the post pandemic world

The World Health Organization (WHO) recently declared that COVID-19 is “…now an established and ongoing health issue which no longer constitutes a public health emergency of international concern.”[1]. Despite recent celebrations on the official end of the pandemic, COVID-19 remains an infectious disease that, without treatment, could lead to fatalities: there have already been more than 200,000 COVID-19 deaths in 2023 [2], which is likely to be underestimated. Access to nirmatrelvir/ritonavir (Paxlovid), however, an important COVID treatment, will still be limited in many middle-income countries.

Clinical trials suggest that Paxlovid is most effective for preventing progression to severe illness, hospitalization and death among people at high risk for these outcomes.[3][4] Real-life research, conducted in high-income countries, reports that Paxlovid reduces hospitalization among all adults with COVID-19,[5][6] and it is being studied as a possible treatment for long COVID.[7]

Despite its proved efficiency and importance, access to Paxlovid remains highly inequitable: while the price per treatment course in the U.S is $535, the Clinton Health Access Initiative says generic versions could be available for less than $25 per treatment course[8]. Pfizer, which reported Paxlovid sales of $4.1 billion during the first quarter of 2023[9], aggressively opposed the TRIPS waiver proposal, and is unwilling to expand access to affordable generic versions of Paxlovid everywhere it is needed.

On November 16, 2021, Pfizer and the Medicines Patent Pool (MPP) announced an agreement on a voluntary licence for Paxlovid. A study[10] conducted in November 2021 claimed only 10% of global diagnoses came at the time from the 91 countries included in the Pfizer-MPP voluntary license (VL)[11].

At the same time, 29% of diagnoses arise from MICs, ineligible under the VL scope. The Pfizer/MPP VL excludes many middle-income countries (MIC), including Argentina, Brazil, Malaysia and Thailand.

The list of countries included in the Pfizer-MPP deal for Paxlovid should be expanded, as 29% of global diagnoses originate in MICs that are not included. There is no comprehensive rationale behind this approach.”, says Dr. Andrew Hill Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK  .

SARS-CoV-2 is still spreading as vaccine-induced protection against COVID-19 wanes, and new, more infectious variants that can evade immune responses continue to circulate, calling for a test-and-treat approach to prevent serious illness, hospitalization and death – especially among vulnerable and unvaccinated people.  Such VLs limited to countries that lack the capacity to perform COVID-19 testing – without any measures to expand access to testing are pure cosmetics.

“This is a scattershot approach that fails to consider what is needed for a robust and effective public health response to COVID-19,” says Othoman Mellouk, Access to Diagnostics and Medicines Lead at the International Treatment Preparedness Coalition. “All low-and-middle income countries should have access to affordable generic versions of Paxlovid, and be resourced to conduct test-and-treat initiatives.”

[1] https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic
[2] https://covid19.who.int
[3] https://www.nejm.org/doi/full/10.1056/nejmoa2118542
[4] https://s28.q4cdn.com/781576035/files/doc_presentation/2021/12/17/COVID-Analyst-and-Investor-Call-deck_FINAL.pdf
[5] https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e2.htm
[6] https://www.acpjournals.org/doi/10.7326/M22-2141
[7] https://medicine.yale.edu/news-article/participant-centric-trial-will-test-if-anti-viral-paxlovid-can-help-with-long-covid/
[8] https://www.clintonhealthaccess.org/news/chai-announces-agreements-with-leading-generic-manufacturers-to-make-affordable-covid-19-treatment-available-in-low-and-middle-income-countries
[9] https://www.fiercepharma.com/pharma/pfizer-pulls- q1-surprise-sales-covid-products-despite-plummeting-demand
[10] Toby Pepperrell, Leah Ellis, Junzheng Wang, Andrew Hill, Barriers to Worldwide Access for Paxlovid, a New Treatment for COVID-19, Open Forum Infectious Diseases, Volume 9, Issue 9, September 2022, ofac174, https://doi.org/10.1093/ofid/ofac174
[11] As of 9 May 2023 there were 95 countries in total included into Pfizer-MPP voluntary license https://medicinespatentpool.org/licence-post/pf-07321332
[12] Toby Pepperrell, Leah Ellis, Junzheng Wang, Andrew Hill, Barriers to Worldwide Access for Paxlovid, a New Treatment for COVID-19, Open Forum Infectious Diseases, Volume 9, Issue 9, September 2022, ofac174, https://doi.org/10.1093/ofid/ofac174
[13] As of 9 May 2023 there were 95 countries in total included into Pfizer-MPP voluntary license https://medicinespatentpool.org/licence-post/pf-07321332

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