Jamie Bay Nishi, MS

Awaiting a chance to prove themselves, key technological advances that enabled swift development of vaccines against SARS-CoV-2 stood by for years before the pandemic struck. Chief among these were mRNA-based vaccines, which stalled in early-stage development. Research funders questioned the scientific merit of novel immunological approaches; major vaccine producers doubted their profit potential. Nevertheless, a handful of innovation-seeking public-private development partnerships, fueled by hard-won support, drove novel vaccine platforms forward just as SARS-CoV-2 gripped the world.As with much else, the COVID-19 pandemic upended vaccine research and development (R&D), leaving the world’s largest vaccine makers to play catch-up with smaller companies focused on vaccine innovation. Biotech start-ups capitalizing on cutting-edge technologies increasingly are driving vaccine development, which in turn is shedding its image as an investment backwater. Maintaining this momentum through ongoing investment in technological innovation can drive breakthroughs to thwart future pandemic threats, as well as endemic diseases that kill millions each year.During the early months of the historic rollout of vaccines to fight COVID-19, the Sabin Vaccine Institute’s Influenzer Initiative asked experts and innovators specifically to reflect on the past, present, and game-changing future of mRNA vaccine protection against a range of viral threats, including influenza. Exciting insights from these conversations are featured in the initiative’s latest video episode. As several of those interviewed attest, mRNA vaccines exemplify how basic discovery research coupled with targeted translational investments remain the engine of transformative innovations that save uncountable lives and immeasurably improve their quality. Eric Topol, founder of Scripps Research Translational Institute, observes that investments in immunology, virology, and molecular and structural biology provided the foundation for the rapid development of successful vaccines against SARS-CoV-2. David Topham, the founding director of the Translational Immunology and Infectious Diseases Institute at the University of Rochester, notes that vaccine platforms that have delivered us out of the current pandemic were enabled by targeted investments in nanoparticle technology.  Innovations like the COVID-19 vaccines provide benefits that extend far beyond their initial targets, such that every dollar spent on R&D yields five in return, notes economist Benjamin Jones of Northwestern University. In the case of mRNA vaccines, that beneficial ripple effect may include disarming the next pandemic threat. “Today we need methodologies that we can rapidly adapt so that when a new pathogen arises, we can make a vaccine against it,” says Teresa Lambe of Oxford University. That’s a key advantage of the mRNA platform, according to Topol. “mRNA does appear to have the ultimate flexibility,” he observes. “You go from sequence to template in a matter of hours.” SARS-CoV-2 demonstrates the value of this nimble technology, as the triumphant achievement of astonishingly effective vaccines remains threatened by the rise of potentially evasive variants—a long-standing challenge in building defenses against the next influenza pandemic.The challenges and consequences of inequitable access to vaccines has never been more sharply evidenced than by the current pandemic. The relative simplicity of mRNA vaccine manufacturing, as compared with that of traditional vaccine approaches, offers the potential to make vaccines when and where viral threats emerge and more readily available to the people who most need them. Vaccine manufacturing processes should be designed to be globally adaptable, Lambe argues. “All low- to middle-income countries, in fact all countries, should have the ability to make vaccines for themselves and to supply worldwide,” she says. Rajeev Venkayya, of Takeda Pharmaceutical Company, adds that decentralized vaccine production offers benefits beyond those provided by vaccines themselves. He describes how countries new to vaccine manufacturing could “leapfrog” into cutting-edge technology via mRNA vaccine production and build a new ecosystem for vaccine research, development, and distribution. The full potential of mRNA vaccines thus extends far beyond quashing pandemics. Developed and produced according to national or regional needs, mRNA vaccines can create innovative opportunity and healthier futures for people everywhere.Decades will be spent taking the measure of the COVID-19 pandemic: calculating its toll in multiple metrics, defining its vast and diverse lessons, and recognizing the changes it catalyzed. During that time, viruses with potential to cause even greater destruction will emerge. As the recent declaration of G7 leaders emphasizes, we must act now to develop transformative, adaptable, and affordable technologies to meet these threats—a declaration that George Gao, director of the Chinese Center for Disease Control and Prevention, insists must produce action. Among the pursuits he advocates is the exploitation of recently proven vaccine technologies to prevent another pandemic. “mRNA plus nanoparticle vaccines are two important routes for the development of novel influenza vaccines,” he says. Novel vaccines that enable robust, globally accessible disease prevention are within reach, according to Amesh Adalja of Johns Hopkins University. “I don’t think we’re going to be left in such a position with future emerging infectious disease emergencies,” he concludes. We take courage from these words, and those of Venkayya, who expressed his hope “that people will seize this moment to recognize that we could potentially avert the next pandemic.” 

On Saturday, heads of state and government from the world’s leading economies concluded this year’s G20 Summit in Osaka, Japan by issuing a declaration committing to advance global health.Noting that “health is a prerequisite for sustainable and inclusive economic growth,” G20 leaders made a myriad of noteworthy commitments in the G20 Osaka Leaders’ Declaration from advancing universal health coverage (UHC), to controlling noncommunicable and communicable diseases, to tackling health emergencies and antimicrobial resistance (AMR). Recognition of the role of research and new technologies in confronting these challenges was present, but inconsistent.In welcome news, the declaration generally recognized the “importance of science, technology and innovation (STI)” for achieving the Sustainable Development Goals and committed to strengthening health systems to achieve UHC by “promoting public and private sector innovation, such as cost-effective and appropriate digital and other innovative technologies.” GHTC was pleased to see this call out for “affordable” and “appropriate” technologies, which are critical elements for addressing health needs in the world’s poorest places, and that leaders recognized that both the public and private sector have a role to play in accelerating new innovations, such as treatments, vaccines, and diagnostics. But as the declaration delved into particular health challenges, recognition of the importance of research and development (R&D) was somewhat inconsistent.On the positive side, leaders committed to promoting R&D to tackle AMR, noting the ongoing work by the Global AMR R&D Hub, first established under the German G20 presidency to foster international agenda setting and collaboration on research for new antibiotics and treatments. They also called on members and the hub to “analyze push and pull mechanisms to identify best models for AMR R&D.” It is constructive that the G20 committed to moving this agenda forward, as growing drug resistance is complicating the fight against leading global killers, such as malaria, tuberculosis, and HIV and AIDS, which heads of state reaffirmed their commitment to end. A lack of market incentive remains a barrier to spurring new antimicrobial and drug development.AMR is just one emerging threat in our increasingly interconnected world, so we were pleased to see the G20 once again put a spotlight on the importance of improving public health preparedness and the need for sustainable financing mechanisms to prevent and respond to health crises like the current Ebola outbreak in the Democratic Republic of Congo. We were, however, disappointed to see no recognition of the role of R&D and health technologies in enhancing preparedness. Just two years ago, the G20 health ministers, under the German presidency, pledged strong support for collaborative efforts for R&D preparedness, including the Coalition for Epidemic Preparedness Innovations [CEPI] and ongoing work under the World Health Organization’s R&D Blueprint.Despite this criticism, last week’s G20 Summit remains a significant political win for global health advocates—and that’s important to recognize. It was just two years ago that global health, and R&D for global health, featured for the first time ever as part of the G20 leaders’ declaration. With so many pressing global challenges from migration, to climate change, to the impact of disruptive technological innovation, it is promising to see G20 leaders continue to position global health as a priority area for international action and as a critical driver of economic development.In a twist on previous G20 presidencies, last week’s Leaders’ Summit marked a mid-way point in this year’s G20 ministerial process, rather than its usual annual conclusion. With the G20 Health Ministerial Meeting set to take place in October, it is now vital that health ministers build on the positive foundation set at the Leaders’ Summit to put in place more concrete action plans and financial resources to realize the G20’s global health commitments—that rightfully place R&D as a central driver in achieving these goals.

Senator Hillary Clinton famously wrote that “it takes a village.” Meanwhile, President Donald Trump has increasingly called for other nations to pay “their fair share” in global affairs. While these statements may be rooted in differing worldviews, at their heart they share a common truth: It does take the contributions of many to tackle the world’s greatest challenges—including ending diseases that affect the world’s poorest people like HIV and AIDS, tuberculosis, and malaria.The US government has long played an indispensable role in driving global health progress as the world’s leading funder of research and development (R&D) for new vaccines, treatments, and other tools to fight neglected diseases. It is a blue ribbon honor America should wear proudly. It is a show of both our scientific might and our compassionate hearts; it is making a difference—US support has helped advance 42 new lifesaving global health products approved since 2000, including child-friendly malaria medicines and a vaccine to eliminate meningitis A—and it’s greatly needed. Because neglected diseases strike the world’s poorest places, there is little commercial incentive to develop urgently-needed vaccines or medicines, making government R&D investment vital to drive progress.Yet, new research shows that other countries are increasingly stepping up to the plate to fund neglected disease R&D, narrowing the United States’ significant global lead, and that is news that should be welcomed by all Americans, no matter on which side of the political aisle you sit.According to the latest G-FINDER survey by Policy Cures Research, which tracks annual global investment in R&D for neglected diseases, global funding in 2017 reached the highest level ever recorded by the survey—US$3.56 billion, up 7 percent from the previous year and the highest year-over-year percentage increase documented in ten years. Importantly, while the US government did increase its investment by $23 million, countries other than the United States were the primary drivers of this overall global funding growth. Several larger government funders, including the United Kingdom, the European Commission, India, and Germany significantly increased their funding, while smaller donors like South Africa, Brazil, and Japan also increased investment—leading to the most diversified funding pool for neglected disease R&D ever recorded by the G-FINDER.Rarely do Americans like to cede part of our lead in any arena, but in this case, we should feel pride and encouragement that the gap is beginning to narrow between the United States and other funders. The US government’s historical leadership in neglected disease R&D has both built a foundation and set a bar. Now, other nations are striving to follow our lead and meet our example. Millions of people worldwide, including Americans, will benefit.A patients with sleeping sickness in the DRC. Photo: PATH/Georgina Goodwin We are already seeing the incredible gains from past investment in neglected disease R&D. Last year alone we saw the emergence of game-changing new tools like fexinidazole, the first all-oral treatment for sleeping sickness; tafenoquine, the first new treatment for plasmodium vivax malaria in 60 years; and moxidectin, the first new treatment for river blindness in 20 years.However, despite the tremendous progress in global health achieved through innovation, there is still a long way to go. We still don’t have the tools we need to combat many diseases that continue to impoverish communities and threaten health security. New next-generation vector control products, new vaccines and treatments, and improved point-of-care diagnostics are urgently needed.While this year’s global funding increase is cause for celebration and will bring us closer to meeting the world’s R&D health challenges, as a global community we are still falling short of the funding levels needed to deliver health for all and quell emerging epidemic threats. Not a single country in 2017, including the United States, met the World Health Organization recommendation that member states dedicate at least .01 percent of their Gross Domestic Product to research into the health needs of developing countries. Continuing the current positive funding trajectory and ultimately closing the resource gap for neglected disease R&D will take both sustained funding from the US government and increased investment from other nations and stakeholders. The United States can help deliver a safer, healthier world for all. We can’t do it alone, but we can continue to lead the way.

On April 28,  senior leaders from government, the private sector, and the global health community came together in Berlin for a lively discuss on how the G20 can advance global health innovation to drive sustainable development and health security. Here are six key takeaways from that discussion: 1. Global health security can drive economic growth, but health crises destroy economies. While the cost of developing technologies may be significant, the cost of failing to have technologies needed on hand can be far greater. For example, US funding cuts in 2012 stalled development of a promising Ebola vaccine, leaving us without a critical tool needed to stem the 2014 outbreak. The result: Over 11,000 deaths and the collapse of health systems and economies in the three affected West African countries, as well as enormous investment by G20 countries to stem the outbreak. The US government alone spent US$2.4 billion on efforts to combat the disease at its source, in addition to investments at home. On the other hand, investment in global health research and development (R&D) can drive economic growth and job creation. Healthier people lead to healthier economies. 2. Resource mobilization is critical. If there is one message the eclectic group of conference participants can all could agree on, it is that we need additional investment from public- and private-funders to ensure global health security. What was less clear is who will pay for it. Speakers emphasized the vital role governments have to play in funding R&D for poverty-related and neglected diseases (PRNDs) given there isn’t sufficient stand-alone interest from the private industry. German Bundestag member, Stephan Albani, encouraged governments to double their investments in R&D for PRNDs and to continue funding product development partnerships (PDPs), which leverage public- and private-sector contributions to advance health technologies targeting PRDNDs. Other panelists stressed the need to draw in additional support from the private-sector, philanthropy, and other unconventional donors. Tara Hayward from Sabin Vaccine Institute emphasized the need for alternative financing models to stretch investments, while Dr. Kei Katsuno from GHIT Fund discussed his organization’s unique approach to leveraging private and public funds. Katharina Kuss, from the Spanish Foundation for International Cooperation, Health, and Social Affairs, also reminded participants of the need to focus on value-for-money to avoid donor fatigue and continue to engage the private-sector and philanthropy. 3. No one can do this alone; Partnerships are needed. Participants emphasized the need for partnerships in both funding and research. PATH’s Claire Wingfield discussed the unique role of PDPs in drawing together public and private resources and engaging local partners to develop affordable and appropriate technologies for PRNDs, as well as the need to foster an enabling environment for innovation in low- and middle-income countries as they strengthen R&D capacity to address their own health needs. Dr. Peter Jackson from the AMR Centre and Founding Member of CARB-X emphasized the length and high cost of drug development and thus the need for collaboration to bring new antibiotics to market. CEPI’s new CEO, Dr. Richard Hatchett, stressed the need for portfolio partnerships rather than companies working on developing a single vaccine. On the private industry side of our community, Dr. Denis Broun of CEPLA spoke of partnerships with generic companies working on new drug formulations, while Dr. Harald Nusser of Novartis focused on the need for co-creation through multiple partnerships which are less transactional. Professor Helen Rees, Chairperson of the South African Medicines Control Council, raised the issue of medicine affordability for countries as an example of the need for mechanisms of tiered pricing and noted the need for collaboration to ensure tech transfer. 4. We must connect R&D with the overall health system. A new global health technology will only have impact if ultimately reaches the people who need it and is designed for the communities and contexts in which it will be used. Silvia Ferazzi from Medicines for Malaria Venture emphasized that R&D must be viewed as part of broader health systems with product developers and implementers coordinating throughout the R&D process to ensure technologies can be rapidly scaled up at the community level once developed. She also stressed the need for technologies to be designed and adapted to meet the unique constraints of health systems. The need for communities to be engaged at an early stage to inform product design was echoed by both Abdullah Adlahmash of King-Saud University and Dr. Michelle Gayer of International Rescue Committee, while Julie Archer of FIND stressed the need to innovate diagnostics in parallel with drugs and vaccines to enable these tools to be deployed most effectively. 5. Governments DO care, but better coordination is required. Many of the government and multilateral officials in attendance—including German Bundestag member Kordula Schulz-Asche, United Kingdom member of parliament, Jeremy Lefory, and Emanuel Frederico Sotelo from the Embassy of Argentina—highlighted the remarkable gains in global health achieved through new technologies and the stressed their commitment to driving forward global health innovation and strengthening health systems to address longstanding and emerging challenges, including antimicrobial resistance (AMR) and pandemic threats. But attendees also pointed out the need for governments to better coordinate to support new technologies on the journey from lab to bedside. Rob Terry of the World Health Organization (WHO) R&D observatory, discussed his team’s work to create a directory of product profiles to identify priorities and gaps in R&D. Bernhard Schnittger from the European Union (EU) Commission in Germany, stressed the need for alignment between Africa and Europe—in areas of disease surveillance and response, pandemic preparedness, regulatory issues, and capacity building—which H.E. Ajay Bramdeo, AU Permanent Representative to the EU, also reiterated. Ben Alsdurf from TB Alliance focused on the need for streamlined regulatory processes and better coordinated procurement. Discussing the alignment between G20 initiatives and WHO, German B20 Sherpa Dr. Stormy-Annika Mildner noted that the G20 in health can’t divert from the WHO role, but it should set an agenda to streamline initiatives with WHO, and cited five areas where global health is a focus within the G20: Innovation in health, pandemic preparedness, NTDs, AMR, and digital health. 6. These global health challenges impact us all.   Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine, perhaps summed it up best when he shared some surprising new statistics indicating that the majority of cases of certain neglected diseases—including HIV and AIDS, malaria, and tuberculosis—currently exist within the G20 countries, so this is an area which countries of all economic levels cannot afford to ignore. On a positive note, the Millennium Development Goals helped catalyze a 50-80 percent reduction in preventable child diseases. On a more concerning note, new challenges have emerged: Dengue has returned to Southern Europe and malaria cases are on the rise in Greece. Call to action! It’s clear that neglected diseases can no longer be seen as a distant concern only affecting the global south. In this increasingly globalized world where diseases know no borders and our security and economies are intertwined, the leading countries of the world must come together with a coordinated approach to ensuring global health security. That’s why we are calling on all interested parties to sign on to our call to action for G20 leaders to commit investment in research, innovation, and development of innovative health technologies to counter threats posed by AMR, PRNDs, and pandemics. We are working to include global health innovation on the agenda for the B20 meeting, and continue to engage in dialogue with representatives from Argentina and India, the next two G20 hosts and national ministers and heads of government. Join us!

Science expands our understanding, makes the impossible possible, and helps us build the future we want for all people. Science drives the work of our Global Health Technologies Coalition, so we wanted to take a step back to reflect on five ways science is transforming global health:1. Science is generating treatments, cures, and vaccines to tackle the world’s most devastating diseases.  From a vaccine that has put us at the brink of eradicating polio to antiretroviral treatments that have dramatically extended the lives of people living with HIV and AIDS, science has generated new health technologies that have driven tremendous progress in global health. Thanks to investments in science and research, 82 new vaccines, drugs, diagnostics, and other lifesaving global health tools have been developed and introduced since 2000. These tools include a new meningitis A vaccine—which has already saved 378,000 lives and prevented 673,000 new infections since 2010—and new child-friendly malaria drugs that have helped cut childhood malaria deaths by 65 percent since 2000. Science has also fueled a robust pipeline of over 670 global health technologies now in development poised to further build upon these gains.2. Science is helping us understand the unique needs of users and communities so we can design the right tools for impact. A scientist assembles a point-of-care diagnostic test. Photo: PATH/Dan ChangDriving progress in global health is not just about developing tools that work; it’s about developing tools that work for the communities and contexts in which they are used. A diagnostic test won’t help us identify and control an emerging epidemic unless it can be administered on the spot in remote communities and deliver results quickly. Likewise, a woman is not likely to adopt a new contraceptive or HIV and AIDS prevention method unless it’s easy-to-use, comfortable, affordable, and fits in with her lifestyle and culture. Through surveys, data analysis, diagnostics, and user testing, science is enabling us to study end users and the environments and social systems in which they operate. This helps us better understand the complexity of their unique needs and design and refine technologies to deliver the most effective solutions for impact.3. Science is helping us predict, detect, and track emerging health risks so we can be better prepared to confront tomorrow's challenges. From using weather patterns to forecast the risk of insect-borne disease outbreaks, to employing genomics and evolutionary theory to predict how bacteria will become resistant to antibiotics, to advancing new hybrid systems that combine crowdsourced data with traditional disease surveillance, science is helping us better predict, detect, and track infectious disease outbreaks and other emerging health challenges. Early detection can make the difference between an outbreak becoming an epidemic and is critical to mounting an effective response.4. Science is helping us understand what works and what doesn't so we can better target interventions and design health programs for maximum impact.  How often does an insecticide-treated bed net need to be replaced, and how many tears can it sustain before its stops working? In an era of limited resources, can we predict which technologies and interventions are likely to save the most lives in a country if brought to scale? How do we get people to change their handwashing habits to reduce diarrheal disease and childhood deaths? These are the questions big and small that scientists, data analysts, and other health researchers are working to answer in labs, offices, and program sites across the United States and world. The answers they get are helping us better target health solutions and refine health programming to more save lives and more dollars.5. Science is putting information and data at our fingertips to help us fight global diseases and health challenges in new and unusual ways. The revolution in mobile technology, digital health, and big data is transforming our approach to fighting global diseases and health challenges. Health care workers are using mobile devices to track immunization coverage door-to-door and monitor vaccine supplies to prevent stockouts, doctors are using SMS to remind patients to take their tuberculosis drugs and treatment adherence, and health ministries are deploying new data visualization toolsto turn a mountain of data into accessible and actionable information to guide decision on to best deploy and target resources.Science creates a foundation upon which improvements in global health are built. It unlocks discoveries and fuels innovation, informs policies and programs, breaks down barriers, and ultimately advances better, healthier lives for all people. At this moment in time, it is more vital than ever that we build a convincing case of the benefits that flow from science and the importance of strong investment in science and research.In global health, science matters because #scienceserves and science saves.