Supply & Demand of Oral Therapeutics
Despite broad licensing to generic manufacturers through the Medicines Patent Pool, generic production is unlikely to make a meaningful contribution to supply this year and manufacturing capacity will be largely limited to that of the originator companies, Merck and Pfizer. Merck expects to produce 30 million courses by the end of 2022 and Pfizer expects to produce 120 million courses.
Purchases for both drugs began even before the first regulatory authorizations were received. Pfizer’s drug Paxlovid (nirmatrelvir/ritonavir) demonstrated strong efficacy data in Phase 3 clinical trials and therefore has been in greater demand. Almost the entire available supply of Paxlovid for the first half of the year has been purchased but there is still significant supply available later in 2022.
Similar to what we saw with vaccines, the majority of the purchases for oral therapeutics to date have been placed by high-income countries, with no purchases by low-income countries. Merck has allocated 3 million courses of molnupiravir to UNICEF throughout the first half of 2022 “for distribution in more than 100 low- and middle-income countries following regulatory authorizations.”
Global Fund has signed an agreement with Pfizer for the procurement of up to 6 million treatment courses of Paxlovid (nirmatrelvir/ritonavir). This will make the treatment available to all 132 countries eligible for Global Fund grants, subject to local regulatory approval and authorization. Pfizer expects supplies of Paxlovid to become available in 2022 dependent upon regulatory approval and country demand. This builds on Global Fund and other partners’ announcement at the Second Global Summit to support test-and-treat programs in over 20 LMICs.
UNICEF has announced a supply agreement with Pfizer for 4 million courses of Paxlovid, dependent on “country demand, clinical recommendations, and necessary approvals.” Pricing information is not publicly available. Merck has also allocated 3 million courses of molnupiravir to UNICEF throughout the first half of 2022 “for distribution in more than 100 low- and middle-income countries following regulatory authorizations.” At the Summit, Merck committed to make another 2 million courses available to USAID at the company’s “best access price.”
Africa CDC has signed a memorandum of understanding (MOU) with Pfizer to make Paxlovid available to countries on the continent at cost. After the announcement of the MOU, Zambia has announced plans to begin procuring Paxlovid.