Science, Innovation, and Society in the Age of Pandemics: Reflections From the Inaugural Sir Alasdair Breckenridge Lecture.

The Centre of Regulatory Excellence (CoRE) launched an annual lecture series on April 8, 2021 in Singapore to honor the memory of CoRE’s founding Chair, the late Professor Sir Alasdair Breckenridge. The inaugural Sir Alasdair Breckenridge Lecture was delivered by Professor Sir Jeremy Farrar, Director of the Wellcome Trust on the topic of “Science, Innovation, and Society.” Sir Jeremy highlighted the importance and inter‐connectedness of these three themes in the context of coronavirus disease 2019 (COVID‐19).

The 1999 Nipah virus outbreak first detected in pig farmers in Malaysia, which subsequently spread to Singapore, heralded the modern age of pandemics. In the 20 years since Nipah was first identified, Singapore and many other countries in South, Southeast, and East Asia have responded to new outbreaks of Nipah and successive pandemics, such as severe acute respiratory syndrome (SARS), H1N1 influenza, and Middle East Respiratory Syndrome (MERS). The experiences of and lessons learned by these countries have contributed to their resilience during the current COVID‐19 crisis.

In December 2019, Duke‐NUS Medical School and the Coalition for Epidemic Preparedness Innovations (CEPI) organized a conference in Singapore reflecting on Nipah after 2 decades. Within the conference, CoRE and CEPI hosted a regulatory roundtable that discussed how regional regulatory collaboration and regulatory agility could be advanced to allow rapid development and access to pandemic vaccines. We did not know then how relevant those discussions at the Nipah conference would soon become when just a few weeks later a novel coronavirus was reported in China.

COVID‐19 will not be our last pandemic and science, innovation, and regulation will need to be agile to respond to the global challenges ahead, across borders and sectoral boundaries. Many of the drivers of the current age of pandemics, such as climate and ecological change, the human‐animal interface and urbanization will remain prevalent throughout the 21st century. In this context, we reflect on four key take‐aways from Sir Jeremy’s inaugural lecture that will stand us in good stead for the current COVID‐19 pandemic and as we prepare for other challenges ahead.

SCIENCE CAN ONLY HELP END PANDEMICS IF THE OUTPUTS OF RESEARCH ARE EQUITABLY DISTRIBUTED

Since the start of 2020, we have witnessed dramatic progress and developments in science, spanning genomic sequencing techniques, diagnostics, therapeutics, and the rapid development and approval of vaccines, due to the COVID‐19 response.

Vaccinations can provide the key element for the exit strategy to the current pandemic but only if the maximum number of people are inoculated. At the end of September 2021, only 2.2% of people in low‐income countries had received at least one dose of COVID‐19 vaccine. The World Health Organization (WHO) Director‐General Dr. Tedros has called on wealthier nations to share vaccines urgently to avoid a “catastrophic moral failure.” Besides the ethical imperative to make life‐saving vaccines available to all, nations with more resources should also consider that uncontrolled epidemics anywhere in the world increase the risk of new variants emerging that could evade vaccine‐induced immunity and reignite the global pandemic even in those countries with high vaccination coverage. Indeed, no one is safe until we are all safe.

Inequitable COVID‐19 vaccine distribution demonstrates that it is unsustainable to maintain the status quo of vaccine manufacturing capacity being concentrated in a few countries. There is great room for more innovation in manufacturing. Countries with small populations but with strong regulatory systems and intellectual property protections could become future regional vaccine manufacturing hubs. Such countries can provide for their domestic needs within a quick timeframe, while continuing to manufacture vaccine doses for other countries. Sanofi and BioNTech recently announced that Singapore will be added to their vaccine manufacturing sites. Similar partnerships are being developed in the context of low‐ and middle‐income countries, such as Rwanda and South Africa, to build capacity to manufacture vaccines for their region. Such regions should continue to invest in developing regulatory capacity. The WHO recently launched its policy on evaluation and designation of WHO‐Listed Authorities, replacing the previous Stringent Regulatory Authority list. This can be a key enabler to support vaccine manufacturing in regional hubs. It would also facilitate abridged WHO prequalification assessment of vaccines, and procurement by the United Nations and other multinational agencies.

SCIENCE THRIVES IN AN ECOSYSTEM THAT ENCOURAGES AND SUSTAINS INNOVATION

Long‐term investments in basic science research by governments have enabled the development of adenovirus and mRNA platform technologies that were quickly pivoted to vaccine development for the novel coronavirus. These novel platform technologies have ushered in an incredibly exciting period in science that could contribute to solving some of the world’s greatest challenges, such as HIV/AIDS, malaria, cancer, and dementia. A sustainable innovation ecosystem should take a long‐term view of funding to promote resilience and not just efficiency, be willing to take bold risks, and be independent of the whims of short‐term political cycles.

Current models for funding and sustaining innovation involve significant government investments in basic research while industry accepts a higher degree of risk during clinical development with the promise of recouping investments through commercialization and intellectual property rights. Philanthropies, such as the Wellcome Trust and the Bill and Melinda Gates Foundation, are also able to assume greater risks in development than governments are typically comfortable with. However, governments will need to reassess their risk appetites and funding models to stimulate the kind of transformative innovations needed to address future global health challenges. The successful mobilization of public funds to support basic research and the rapid clinical development and manufacture of COVID‐19 vaccines demonstrates that governments can take bold risks and make investments for the greater public good.

The COVID‐19 pandemic has seen a positive display of regulatory agility globally to facilitate the speedy development and emergency use authorizations (EUAs) of new diagnostics and vaccines. Regulatory agility refers to adoption of risk‐based, context‐driven approaches and regulatory cooperation based on sound scientific evidence and information. Regulatory cooperation was facilitated through existing convergence platforms, such as the International Coalition of Medicines Regulatory Authorities (ICMRA), which convened virtual seminars and working meetings to discuss regulatory considerations for COVID‐19 clinical trials, therapeutics approvals, use of real‐world evidence, and information sharing to support EUAs of new vaccines. Regulators also engaged early and frequently with developers in an iterative partnership. The experience during COVID‐19 is an opportunity to permanently institutionalize such global regulatory coordination to accelerate access to innovative health products and respond to future pandemics and other health challenges.

CROSS‐SECTORAL COLLABORATION IS KEY AS SCIENCE AND INNOVATION EXIST WITHIN A SOCIETAL AND POLITICAL CONTEXT

Science and innovation do not exist in a vacuum but within a particular societal and political context. Regulators strive to maintain scientific independence in their assessment of COVID‐19 health products in spite of intense political pressures during this global pandemic. Besides the scientific challenges posed by the pandemic, society has experienced many ripple effects of COVID‐19. There has been direct impact on hospital resources and surge capacity, indirect impact to care of patients with non‐COVID‐19 conditions, and the broad social and economic impact on workers and students whose jobs and education have been disrupted. In addition, an “infodemic” of scientific misinformation and anti‐vaccine conspiracies fueled by the internet has complicated the pandemic response.

Finally, the COVID‐19 pandemic is occurring during a retreat from global multilateralism and a surge of nationalism. This does not bode well for addressing the future challenges of the 21st century, most of which are going to be transboundary. We must all do our part in our respective fields to continue to foster global collaborations and urge governments to do the same. Ultimately, scientists—including regulators and other health authorities—are responsible to society and should make decisions based on science and not be swayed by political expediency.

MEANINGFULLY INVOLVE PATIENTS AND COMMUNITIES IN SCIENCE AND INNOVATION

Scientists should involve patients and the public in the scientific evidence‐based journey in a meaningful way and not just as an after‐thought. In some regions where public involvement in regulation is more institutionalized, regulators have been able to increase public understanding about novel vaccines. This was evidenced by livestreamed public hearings and the release of technical and plain‐language documents summarizing the evidence received from developers. In most countries, however, such transparent processes and public participation in regulatory decisions are not the norm. It is much more difficult to build trust in regulatory processes during a pandemic, especially when trust in government is low. One key lesson from COVID‐19 is that scientific stakeholders should work in “peacetime” to build trust, communicate clearly, and integrate patients and the public in their work. At CoRE, we are working to raise awareness of the value of systematic inclusion of patients in medicines development and regulation, which is still largely nascent in Asia, through our newly established Coalition to Accelerate Patient Engagement (CAPE).

CoRE will continue to uphold the values and principles of our founding Chair, Sir Alasdair Breckenridge, and provide a neutral convening platform where all health system stakeholders including government, industry, healthcare practitioners, and civil society can come together to share best practices and build relationships and trust necessary for scientific innovation. Science, innovation, and society are inextricably interconnected as we collectively face the challenges of the 21st century, including pandemics, climate change, increasing antimicrobial resistance, mental health, and inequality. The lessons from past pandemics and during COVID‐19 show what science can achieve when governments, health systems, philanthropy, and industry are allied to support innovation, with citizens and society engaged and central to the effort.

FUNDING

No funding was received for this work.

CONFLICT OF INTEREST

The authors declared no competing interests for this work.