Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates Health Equity 17/03/2022 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . 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