New Report Proposes Five “Big Ideas” to Transform Vaccine R&D
The vaccine research and development (R&D) ecosystem has yielded life-saving products for decades by leveraging innovation, collaboration, and partnership; but the rapid development of COVID-19 vaccines illustrated that even more is possible when the right circumstances are in place to catalyze progress. Vaccine R&D consists of a number of complex processes led by a range of different actors, which can present challenges to meeting the pressing threats of emerging and endemic diseases.
A group of experts, convened by the Sabin Vaccine Institute and the Aspen Institute to explore pressing issues for vaccines and immunization, recently came together to examine vaccine R&D and discuss potential solutions to these challenges. The latest report published by the Sabin-Aspen Vaccine Science & Policy Group offers recommendations for resolving persistent challenges to vaccine R&D. The report, Powering Vaccine R&D: Opportunities for Transformation, calls for restructuring the vaccine R&D ecosystem to meet the challenges of infectious diseases more effectively and efficiently.
In the report, five “Big Ideas” emerge that will engender a more responsive approach to vaccine R&D. They are:
- Define leadership roles and responsibilities and establish mechanisms of accountability to prepare for the R&D demands that surface in a pandemic.
- Promote transdisciplinary research that brings people together across fields to expand and advance vaccine science.
- Reimagine clinical trials for more efficient and nimbler approaches.
- Restructure regulatory science and process to reflect advances in vaccine R&D.
- Position vaccines as a public good and align incentives so that all sectors of society benefit.
Let’s take a closer look at each of the five Big Ideas found in the report:
Define leadership roles and responsibilities and establish mechanisms of accountability to prepare for the R&D demands that surface in a pandemic.
To combat the threat of infectious diseases, global health organizations must be prepared to act in real-time, utilizing a multipronged structure that anticipates R&D needs before they become acute and delegates responsibility for each part. Leaders should convene to develop advance plans, establish roles and responsibilities, and engage partners around the globe.
Promote transdisciplinary research that brings people together across fields to expand and advance vaccine science.
The rapid response to the COVID-19 pandemic was made possible in part by leveraging innovative scientific achievements from a broad array of fields. Future vaccine development will depend upon input from adjacent scientific areas, and R&D must support a research infrastructure that creates opportunities for novel approaches and risk-taking.
The group recommends measures to foster unexpected discoveries across disciplines that have historically been distinct from one another; bring together funding mechanisms to support vaccine science; leverage lessons from new scientific areas to foster innovation; distinguish between the intensity of the R&D efforts needed for pandemics and those for long-standing endemic diseases; and ensure that an incentive structure exists to promote and support transdisciplinary research.
Restructure regulatory science and process to reflect advances in vaccine R&D.
A new vaccine typically takes years or even decades to develop due to complex structural challenges and the rigors of the testing process. Speeding up the process will require a number of key changes, from streamlining preclinical evaluation to harmonizing global regulatory standards. Innovations are needed to streamline preclinical evaluation; make vaccine trials faster, nimbler and more cost-effective; and enhance product scale-up, manufacturing and postmarketing surveillance.
Reimagine clinical trials for more efficient and nimbler approaches.
Clinical trials typically run sequentially, but the accelerated development of COVID-19 vaccines showed the process could run parallel. By bringing together large datasets and analyses of clinical and laboratory information, regulatory approvals can follow smaller and faster trials. Particular attention must be paid to establishing equity and efficiency as prime drivers in clinical trials. Engaging low- and middle-income countries in the clinical trial process from the start and developing research capacity and local trial networks are essential to establishing more efficient and nimbler approaches to clinical trials.
Position vaccines as a public good and align incentives so that all sectors of society benefit.
When we compare vaccines to a public utility, opportunities to propel R&D emerge. We should develop policies and practices that promote information sharing and develop criteria to help determine which incentives should be offered and when mandates may be necessary. The COVID-19 pandemic and its vaccine R&D response offer an opportunity to examine incentives and strategies that encourage key players, including governments and philanthropies, to pursue a similar outcome for other vaccine-preventable diseases.
The rapid development and roll out of COVID-19 vaccines in many countries show what is possible when global health leaders, governments and other entities join forces on a single goal. Using this recent pandemic as an opportunity for learning, the Big Ideas presented in this paper offer a path forward to reexamine and restructure vaccine R&D. The time to transform the vaccine R&D ecosystem is now, not only to prepare for the next pandemic but to continue progress toward a world free of vaccine-preventable diseases.