Pfizer's Paxlovid access brought into question as WTO set to discuss patent waiver—again

Pfizer’s oral COVID drug Paxlovid has become a standard of care for treating non-severe patients in high-income countries. But advocacy groups remain critical of the drug’s lack of equal access.

Low- and middle-income countries are receiving only 26% of Paxlovid courses despite them accounting for 84% of the world’s population, a report by Oxfam and the People’s Vaccine Alliance has found. The organizations reached the finding based on data from health analytics provider Airfinity.

The report focuses on supply agreements that Pfizer has already signed. After winning an initial FDA emergency authorization in December 2021, Pfizer has inked deals to ship about 31.8 million courses of Paxlovid to wealthy countries, representing 74% of all its orders thus far, the report shows.

Not only do low- and middle-income countries have larger populations, but fewer of their residents are vaccinated than in rich countries. This makes their populations more vulnerable to severe COVID and in more need of Paxlovid, the two organizations argued.

Pfizer didn’t immediately reply to a Fierce Pharma request for comment.

Pfizer has made various efforts toward more equitable access to Paxlovid. A year ago, the New York pharma penned a voluntary license agreement with the Medicines Patent Pool (MPP), granting generics makers permission to produce Paxlovid copycats for 95 low- and middle-income countries covering about 53% of the world’s population. In May, MPP unveiled a list of 35 companies that have gained sublicenses to manufacture generic versions of Paxlovid.

As Oxfam and the People’s Vaccine Alliance noted in their report, these MPP agreements will only start to produce and export finished drug products at scale in early 2023.

In May, Pfizer also partnered with the Clinton Health Access Initiative and undisclosed generic manufacturers to make generic Paxlovid available to some low- and middle-income countries at under $25 per treatment course. The companies together committed to a capacity of 4.5 million courses per month. But Oxfam and the People’s vaccine Alliance pointed out some middle-income countries not included in the deal have reportedly been paying as much as $250 per course of Paxlovid.

In September, Pfizer announced a pact to allocate up to six million courses of Paxlovid to Global Fund, which includes 132 eligible countries. Through this channel, Pfizer is offering Paxlovid at tiered pricing, in which low- and lower-middle-income countries will pay a not-for-profit cost.

The two groups also used the new report to launch another attack at Pfizer’s Paxlovid patent, calling for a forced intellectual property waiver through the World Trade Organization. The international trade body in June reached a deal to allow compulsory licenses for COVID vaccines but didn't agree on terms covering all COVID-related products. 

Now, the WTO’s TRIP Council is scheduled to meet again Tuesday. Oxfam is calling for an extension of the patent waiver to include treatments and diagnostic tests. As part of the original decision, the WTO gave itself a six-month deadline to decide whether to extend the waiver to other COVID products.

As antibody drugs lose efficacy against new coronavirus variants, Paxlovid has become more important in treating COVID, and its more convenient oral dosing also holds an advantage over infusions. Based on existing supply contracts, Pfizer has earlier this month reaffirmed its expectation that Paxlovid sales will reach $22 billion in 2022.