Positive drug endorsements from regulatory bodies rarely come with an admonishment. But that’s what the World Health Organization has done in its green light for Pfizer’s COVID-19 oral antiviral, Paxlovid.
While making a “strong recommendation” for use of the pills in at-risk patients with mild-to-moderate COVID, the WHO also implored Pfizer to make the treatment more readily accessible to the world.
“Availability, lack of price transparency in bilateral deals made by the producer and the need for prompt and accurate testing before administering it are turning this life-saving medicine into a major challenge for low- and middle-income countries,” the WHO said in the opening paragraph of its release.
Last month, Pfizer agreed to supply 4 million courses of Paxlovid at a not-for-profit price to 95 low- and middle-income countries, covering 53% of the world’s population.
And in November 2021—before the FDA approved Paxlovid—Pfizer struck a sub-licensing deal with UN-backed Medicines Patent Pool to provide the technology to produce a generic version of the drug. Last month, the MPP revealed that 35 companies around the world had signed on to manufacture the generic.
But many poor nations aren’t covered by the deal, and those that remain in need as the scale-up to produce the pills is ongoing. The WHO adds that it is in discussion with generics makers but the “prequalification” process to allow it to be supplied is time-consuming.
One needy country not covered by the MPP deal is the Dominican Republic. Pfizer is under fire from advocacy groups for not providing access to the technology to produce a Paxlovid generic and for declaring its intellectual property as a “human right.”
Pfizer defends its position, pointing to its initiatives to expand access. “To enable broad reach, we have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers that considers the current evolution of the disease and the impact of infection prevention and control measures to optimize overall supply and access of a safe and effective treatment to the most vulnerable parts of the world,” the company said via email on Friday.
The WHO says that Pfizer’s lack of transparency is “making it difficult for public health organizations to obtain an accurate picture of the availability of the medicine, which countries are involved in bilateral deals and what they are paying.”
In addition to its blessing of Paxlovid, the WHO has reversed its decision on Gilead’s antiviral medicine, Veklury, recommending it for at-risk patients with mild-to-moderate COVID. The agency previously had suggested against its use in any COVID patient.
The new recommendation was based on updated data that show a benefit. The WHO added that it is considering allowing the use of Veklury in patients with a severe form of the virus.