Exclusive: Vaccine org CEPI under pressure to share pricing agreements

Activist groups are calling on the Coalition for Epidemic Preparedness Innovations to take steps to improve transparency and access, including publishing the terms of any pricing agreements that the organization reaches, in an open letter exclusively shared with Devex. CEPI, which launched in 2017 to develop immunizations against emerging infectious diseases, was a key player in the COVAX partnership that ultimately fell short of delivering equitable access to COVID-19 vaccines. It is now leading a 100 Days Mission — an initiative to develop the capacity to respond to the emergence of any new disease with a vaccine within 100 days. “CEPI is one of the privileged and important organizations standing in a position to help make key investments that will combat future threats quickly and as equitably as possible,” Peter Maybarduk, who directs Public Citizen’s access to medicines group, told Devex. “We need to have a better public understanding of not only what those public investments are, but the terms under which they are being made.” The coalition has already struck several partnerships in pursuit of the 100 Days Mission, including arrangements with Moderna to use the drug company’s messenger RNA platform technology to manufacture vaccine candidates based on CEPI-funded research and BioNTech to advance mRNA vaccines for mpox. As it prepares for the emergence of an unknown virus, CEPI continues to pursue partnerships to develop vaccines against a variety of priority pathogens, including Ebola and Lassa, and funds additional efforts to advance vaccine technology. Activist groups Public Citizen, the People’s Vaccine Alliance, Health GAP, and Médecins Sans Frontières Access Campaign are looking for CEPI to release significantly more information about all of those agreements. That includes: • Releasing the terms of any pricing agreements and information on how CEPI will ensure affordability; • Disclosing any agreements related to the supply and delivery of products to low- and middle-income countries, including details on any doses that are being stockpiled for investigational efforts; • And making available the terms around licensing and technology transfer of any products that result from CEPI’s investments. They are also pushing CEPI, which draws much of its funding from public sources, to require the companies they work with to license intellectual property and transfer their technology to manufacturers from LMICs and WHO partners, including the mRNA technology transfer program that includes biomanufacturers in 15 LMICs. A CEPI spokesperson told Devex the organization “embeds contractual equitable access obligations into each of its vaccine development funding agreements as an important lever to enable equitable access.” But they cautioned that because of proprietary confidential and financial information they could not comply with all of the activist groups’ requests, including publishing the agreements in full. Nevertheless, they said many of those agreements “include requirements to transfer technology to additional manufacturers, including those based in the global south, under certain circumstances.” In addition, the CEPI spokesperson said it would not be realistic to impose “template access terms across our portfolio” because “each CEPI-supported vaccine candidate is designed to address a specific problem, population or environment,” proscribing a “one-size-fits-all approach.” Maybarduk pointed out that while CEPI might feel it is untenable to release an unredacted agreement, there should still be room to discuss what information was critical to the public interest which might outweigh privacy concerns. The open letter follows a COVID-19 response that was plagued with inequitable access to vaccines, therapeutics, and diagnostics. Vaccine manufacturers such as BioNTech and Moderna benefited from publicly funded research but were not required to share their IP technology or to make transparent the terms of their purchase agreements. Maybarduk faulted CEPI for not leveraging all of its power as one of the organizers of COVAX to push for affordable access. CEPI has spelled out a commitment to equitable access, publishing both an Equitable Access Policy and Framework. In those documents, the coalition pledges to maintain investigational stockpiles that can be used for free during an outbreak and to coordinate with the global health community to enable the licensing of vaccines that CEPI funded. The coalition also pledges to “ensure the procurement, allocation, deployment and administration of licensed vaccines to protect global health, at a price that does not limit equitable access and is sustainable to the manufacturer.” The CEPI spokesperson explained additional steps the organization has taken to ensure they are meeting their commitments to equitable access, including publishing summaries of the access provisions in their COVID-19 and priority pathogen portfolio funding agreements and making the full agreements available to their board and investors. “This approach has to date been broadly acceptable to most of our stakeholders,” the spokesperson wrote in an email while promising “We will continue to work with our civil society and advocacy partners to consider additional steps we might take to address their concerns and to pursue our shared goal of enhancing equity to life-saving vaccines.” Some of the agreements CEPI has reached in pursuit of its 100 Days Mission nod to equitable access. A partnership with Emervax to advance circular RNA vaccine technology and with the University of Oxford to develop prototype vaccines both commit to ensuring equitable access in line with the Equitable Access Policy. “We need to have a better public understanding of not only what those public investments are, but the terms under which they are being made.” --— Peter Maybarduk, director, Public Citizen’s access to medicines group The Oxford agreement pledges to make vaccines first available to the people who need them most, regardless of ability to pay. The Emervax partnership includes a commitment to technology transfer. While Maybarduk acknowledges the importance of these commitments, “There’s a question of being able to ensure CEPI can adequately enforce them, which would be easier to do if they’re public.” The open letter to CEPI also raises doubts about the lack of detail behind those public statements: “Brief summaries and variable indications of access terms included in agreements are insufficient to protect the public interest and limit the public’s ability to support CEPI in its mission.” Then there are the concerns that arise from agreements such as the deals with BioNTech and Moderna, which are even vaguer in their commitments and include no promise of technology transfer. The BioNTech agreement promises affordable access to an mpox vaccine in LMICs, but the open letter faults the lack of detail on how the price will be arrived at and how delivery of the vaccine will be monitored and executed. The agreement with Moderna is particularly troubling to Maybarduk because CEPI will be sending its antigen designs to generate clinical trial material using Moderna’s platform. While CEPI says it will retain control over the designs, it is unclear who will retain the IP over the final product. “Owning and having exclusive commercial rights would be a windfall for Moderna,” he said. The CEPI spokesperson told Devex that if any of the antigens designed on Moderna’s platform are ultimately used in developing a vaccine candidate, CEPI’s contract with Moderna requires the vaccine “be made available at affordable pricing to public sector procurers for use in LMICs.” But Maybarduk said that while activists “appreciate the goals, it sure would be helpful to be able to read the particular provisions rather than rely on a brief statement of principle.”