Navigating the World that COVID-19 Made: A Strategy for Revamping the Pandemic Research and Development Preparedness and Response Ecosystem

Navigating the World that COVID-19 Made: A Strategy for Revamping the Pandemic Research and Development Preparedness and Response Ecosystem
Thomas J. Bollyky, Jennifer B. Nuzzo, Matthew P. Shearer, Natasha Kaushal, Samantha Kiernan, Noelle Huhn, Amesh A. Adalja, Emily N. Pond
Johns Hopkins – Center for Health Security
October 29, 2021 :: 53 pages
PDF: https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2021/211029-PandemicVaccineDevelopmentReport.pdf

Introduction [excerpt]
…Beyond its human and economic toll, the COVID-19 pandemic has also exposed and redefined the realities of the global vaccine R&D and response ecosystem in the following ways:
There is now widespread recognition that safe and effective vaccines provide unparalleled health, social, and economic benefits during a pandemic. Multiple governments have already announced new and potentially competing plans to invest in pandemic vaccine R&D and response. For example, China, which hardly shipped any vaccines abroad prior to the pandemic, has now become the largest exporter of COVID-19 vaccines to date.

COVID-19 has made it clear that most nations will not share scarce supplies of early vaccines and related inputs in a crisis. From the United States to Europe to the African Union, efforts are underway to domesticate vaccine manufacturing and their associated supply chains. This “me-first” approach to COVID-19 vaccine allocation could also dim countries’ enthusiasm for participating in future global pooled procurement initiatives and access and benefit sharing arrangements, given the reasonable fear that these arrangements might not be able to provide timely, equitable quantities of vaccines for LMICs in future crises.

COVID-19 demonstrated that pandemics can be profitable for vaccine manufacturers. Record revenues for COVID-19 vaccines has drawn new vaccine developers into the market, but also made them less willing to enter into public sector and nongovernmental organization funding arrangements that impose equitable access requirements that could encumber potential profitmaking.

Geopolitics constrained COVID-19 response and threaten future global health security. Global health emergencies have historically been a cause for increased international cooperation, but the response to the COVID-19 pandemic has been constrained by geopolitical rivalries. In this context, not all nations will be willing to cooperate closely on national security matters, such as pandemic vaccine R&D and response. Cooperation on pandemic R&D and response may be more feasible in groupings of regional partners or like-minded states, with global cooperation instead focused on promoting common standards and scientific collaboration.

Any future pandemic pathogen that emerges will do so in a world changed by and aware of these realities. To ensure that these lessons are heeded and to prevent the devastation of the present crisis from repeating in the next pandemic, governments, international institutions, and private sector actors must immediately act to address gaps and explore opportunities at each step along the vaccine value chain.

The measures to be taken should include:
Develop and fund an inclusive strategy for the R&D of prototype vaccine candidates for future pandemics. Although highly effective vaccines against COVID-19 were developed in record time, shortening vaccine development time even further could yield substantial benefits in the next pandemic. To shorten the development timeframe during a pandemic, research and preliminary trials must be conducted before a pandemic may occur. Candidate vaccines for a representative prototype pathogen within each of the roughly 25 viral families most likely to cause the next pandemic could be developed and taken through Phase 1 clinical evaluation. This would allow the collection of early data on safety, dosage, and schedule of vaccine administration with that particular platform, antigenic target, or other design characteristics. Taking those candidate vaccines through Phase 2 clinical trials could help identify and characterize correlates of protection for those viral families. Conducting preclinical and early-stage clinical research in advance could potentially allow for shorter and much smaller-scale Phase 3 trials when a new virus emerges. Proposals by the Coalition for Epidemic Preparedness Innovations and the US Senate, if enacted and funded, could advance this research and enable vaccines to be developed within 100 days of identification of the next pandemic.

Engage local government and donor financing and policy support to enable global vaccine manufacturing scale up. Producing a safe and effective vaccine within 100 days of a pandemic threat being detected would save significant time and lives. However, the benefits of ensuring that every country can administer vaccines at the same pace as most high-income countries have done in the COVID-19 pandemic would be even larger. Establishing vaccine manufacturing capacity in LMICs is essential to achieving this goal, but it should be viewed as a complement, not a near-term substitute, for investing in the economies of scale afforded by centralized production capacity. To succeed, donors and local governments will need to provide sustained financing, support the use of flexible business models, invest in manufacturing innovations, and establish mechanisms to facilitate and sustain technology transfer.

Create and support equitable financing, procurement, and allocation mechanisms to help end COVID-19 and prepare for the future. Wealthy and vaccine-producing nations governments will always be able to outbid a multilateral procurement body or seize locally produced vaccine doses in a pandemic. Enabling a more equitable allocation of vaccines in the next pandemic requires creating more supply and procurement mechanisms in which vaccine-producing nations are willing to participate on the same level as LMICs. COVID-19 Vaccines Global Access, or COVAX, has achieved much during this pandemic, but concerns about its performance in the present crisis make it unlikely to be trusted in the next one. Regional mechanisms may offer the most hope, but they must be established in advance and routinely used to be trusted in future crises.

Strengthen cross-border trade, standardization, and supply chain transparency in order to expand vaccine manufacturing and access during a crisis. The widespread use of export restrictions during the COVID-19 pandemic has contributed to unnecessary infections, hospitalizations, and deaths and continues to undermine efforts to prepare for future pandemic threats by discouraging international investments in vaccine and input manufacturing capacity. The threat of export restrictions on vaccines and related inputs should be reduced through adoption of regional trade and investment agreements, standardization of the specialized inputs needed for vaccine production, and greater supply chain transparency.

Build the systems needed to enable vaccine distribution, allocation, and uptake for the next pandemic. While inadequate supplies may still be the single biggest factor limiting vaccine coverage globally, COVID-19 has also illustrated the need to devote adequate and timely attention to distributing and allocating vaccines and communicating with the public about vaccine-related risks and benefits. Dedicated plans are needed to ensure that high-priority groups can be vaccinated. Operationally feasible plans are also needed to support risk communication and community engagement and to combat the spread of misinformation and disinformation about vaccines.

Plan for global coordination of postmarket research studies. Insufficient coordination of postmarket studies is compromising the ability to track COVID-19 vaccine effectiveness, monitor vaccine escape, and assess optimal dosing and the need for boosters. An independent, but government-supported organization, such as the Coalition for Epidemic Preparedness Innovations, could provide this level of international coordination of follow-on clinical investigations, in consultation with national regulatory authorities and research institutes. The World Health Organization could also assume a greater coordinating role on postmarket research studies by adapting its R&D Blueprint for Action to Prevent Epidemics.

Although COVID-19 has been described as a once-in-a-century crisis, another pandemic could occur at any time, including in the not-to-distant future. Other pandemic pathogens could emerge at any time, causing loss of life or quality of life and spillover economic, social, and political effects at the same, if not greater, magnitude than the world has suffered over the past 2 years. No one can say for certain how governments will respond when the next crisis emerges. What is certain is that national, regional, and international responses to COVID-19 are already writing the opening chapters of the next pandemic. Only by translating lessons learned into viable, equitable action can the world change the pandemic narrative in time for the next crisis.