STRATEGY For anycollaborative mechanism to be successful, equityhas to be embedded in the R&D process

Nikolaj Gilbert,President and CEO,PATH in an interaction with Kalyani Sharma emphasises that for a global vaccine research collaborative to succeed,it will need to be a representative, end-to-end global platform,involving stakeholders across the vaccine R&D ecosystem

Can global vaccine collaboration yield success or is it doomed to be overshadowed by national interests?

At the height of the COVID19 pandemic, while there was unprecedented cooperation, we also saw nationalist interests overshadow the larger spirit of global collaboration. If we want to prepare better before the next health emergency, global cooperation in vaccine R&D is critical. There will be hard negotiations, driven by national priorities, like on intellectual property rights, regulations, and access to inputs for vaccine development. The Global South will be equally vocal on a more liberalised intellectual property regime to allow a level playing field, co-creation, and codevelopment of vaccine platforms rather than technology transfers, regulatory harmonisation, and effective representation when the framework for vaccine collaboration will be negotiated. I see India, the current G20 President, as a powerful voice of the Global South.

The WHO’s proposed Medical Countermeasures Platform identifies three pillars – vaccines, diagnostics and therapeutics– where urgent collaboration is needed to counter the risks of a new pandemic. During the recently concluded G20 Health Working Group meeting in Hyderabad, there were discussions around a global vaccine research collaborative that could pave the way for this larger collaboration. Needless to say, for any collaborative mechanism to be truly global and successful, equity has to be embedded in the R&D process, and the knowledge produced should be considered a global public good, which is readilyaccessible and available to all.

What is the role of international clinical trial networks and regulatory harmonisation in accelerating vaccine development?

Historically, bottlenecks in vaccine development arise due to limited funding or infrastructure for clinical trials, complex regulatory processes, non-availability of raw materials or lack of manufacturing capabilities. There are also significantly differing regulatory requirements, varying across regions, and by independent organisations, national regulatory authorities (NRAs), and the World Health Organization. These can further complicate and delay vaccine development.

Building capacity and infrastructure in LMICs is important, since many of the new vaccine candidates are developed against diseases found in these settings. One of the challenges faced by biotech and vaccine companies is accessing trained and equipped clinical trial sites. This is why, during COVID-19, PATH worked closely with Coalition of Epidemic Preparedness Innovations (CEPI) to create a pool of clinical trial sites in Africa to conduct phase 3 studies.

We need international collaboration for capacity building, providing support for local registration and WHO pre-qualification, as well as building training hubs. A network of networks approach that brings together existing networks and develops newer global or regional networks in epidemiology, clinical, preclinical, central laboratory and regulatory areas is a critical element. We should also work towards strengthening regulatory systems across LMICs to enable vaccine developers to expedite clinical trials and get regulatory approvals for a new technology platform.

How can we build knowledge and technology transfer mechanisms between domestic and global institutions?

More than knowledge and tech transfers, the emphasis needs to be on co-creation and co-development of research and vaccine candidates. The Indo-US Vaccine Action Plan, which has been running since 1987, is a good example of a bilateral partnership which has contributed to India’s indigenous ROTOVAC vaccine as well as expansion of research capacity, training of scientists and publicprivate partnerships.

Vaccine needs differ by region and country, and the R&D ecosystem should be responsive to this. The first step would be to build a Shared Research Knowledge Base, an open access digital database of pathogens with epidemic/pandemic potential from the WHO’s R&D blueprint, as well as a regional prioritisation of these pathogens. There are other initiatives underway, such as CEPI’s One World Vaccine Library concept, which can be a gamechanger. Candidate vaccines for high-risk virus targets will be “deposited” in the Library once they have successfully completed preclinical and early-stage