Emily Bass, Prep4All
Prevention Equity Alert, Link
Executive Summary
Clinical trials that are crucial to future pandemic prevention and current responses to SARS CoV-2 are being delayed by pharmaceutical companies. These companies are able to use government contracts specifying when, where and how current vaccines owned by governments can be used to delay and defer access to these vaccines for research. Current SARS CoV-2 vaccines are a vital part of research for next-generation products such as nasal vaccines and pan-coronavirus vaccines. Next generation candidates need to be tested in animals who have been vaccinated with presently available vaccines to evaluated safety and effectiveness in the context of prior immunization. However, for over two years, the terms of government contracts with industry have had the inadvertent effect of delaying sometimes effectively blocking access to these products for research purposes.
Over the course of a six-month research effort, PrEP4All spoke with US government agencies, research groups, private philanthropy and industry to better understand the causes and consequences of this challenge. The crux of the issue is language in government procurement contracts for vaccines that specifies where and how the vaccine owned by the government can be used. This language does not in any way restrict companies from collaborating with researchers, for example by supplying doses of the vaccine held by the company, according to government sources interviewed for this report.
The contractual language in question, drafted in the context of a global health crisis, has had unforeseen consequences in terms of slowing studies and adding costs and logistical burdens to research activities.
This is an eminently solvable issue that must be addressed now—before new crisis.
Recommendations
In the short term:
- Pharmaceutical companies including Pfizer-BioNTech and Moderna must make vaccine doses available for clinical trials without delay through a simple, transparent application process that does not require the investigator or institute to share or assign intellectual property rights for the experimental product with the company that supplied the vaccine.
In the long term:
- World Health Organization, Gavi, COVAX, the Medicines Patent Pool and governments of countries at all income levels must develop best practices for procurement in health emergencies including consensus boilerplate language for procurement contracts that would safeguard the purchasers’ ability to conduct necessary research on existing products and on next generation products. This language should be referenced in the forthcoming Pandemic Accord, relevant requests for proposals from The Pandemic Fund and in all government funding to industry partners.
