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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Johnson & Johnson (J&J) has moved into phase 3 trials for its COVID-19 vaccine candidate, making the company the fourth vaccine maker to enter late-stage trials in the United States and the first to do so with a single-dose vaccine candidate. In addition to being single-dose, J&J’s vaccine candidate can be stored at refrigerator temperatures for three months, making it more accessible to countries with less health care infrastructure than vaccines that require freezing. The phase 3 trial will be run at sites in the United States, Brazil, Mexico, South Africa, and other countries, and will include significant representation of people over the age of 60 and minorities at disproportionate risk of infection, according to J&J. The company is enrolling up to 60,000 volunteers and has said the trial could yield results by the end of the year, allowing it to seek emergency use authorization in early 2021.The US Food and Drug Administration (FDA) recently authorized for emergency use the first COVID-19 antibody test designed for use at point of care, instead of requiring samples to be shipped and tested at a laboratory. The fingerstick blood test—manufactured by Assure Tech, represented by Azure Biotech in the United States—provides results for two types of coronavirus antibodies within 15 minutes, using a lined strip similar to a pregnancy test. During an independent evaluation run in June, the test was found to have no false-negative results and a 1.2 percent false-positive rate. FDA Commissioner Stephen Hahn emphasized in a statement that point-of-care tests are more convenient, require less resources, and will decrease the time spent running antibody tests, in comparison with tests requiring lab processing.Achieving equitable distribution of a COVID-19 vaccine, once available, will require overcoming substantial financing and misinformation hurdles, according to global health and development leaders who spoke at the United Nations General Assembly. While optimistic that a vaccine will be developed and can end the COVID-19 pandemic, leaders noted the importance of ensuring delivery to all in need, including communities at highest risk. One global mechanism working to ensure such equitable distribution is the COVID-19 Vaccine Global Access (COVAX) Facility, which intends to help ensure a vaccine reaches vulnerable populations by guaranteeing all participating low- and middle-income countries receive enough vaccines to cover 20 percent of their population. The COVAX Facility also includes 64 high-income countries and is working to raise US$2 billion to help produce 1 billion vaccine doses by the end of 2021.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. As COVID-19 vaccine trials continue and expand, several plans for allocation of an approved vaccine are being formed. Preliminary guidance from a strategic advisory group at the World Health Organization, which some experts have said needs more detail before it can be actionable, outlines groups of people who should have priority access to vaccines and urges high-income countries to ensure that low- and middle-income countries receive vaccines early in allocation. Draft recommendations from the National Academies of Sciences, Engineering, and Medicine, developed in response to requests from the Centers and Disease Control and Prevention and National Institutes of Health for vaccine allocation in the United States, also outlines priority groups, but goes a step further to rank those groups in a tiered approach, starting with health care workers and first responders. Both strategies address and emphasize vaccine access for disadvantaged groups, and both plans will continue to be developed in the upcoming months.Computer vision startup Gauss and biotech company Cellex recently announced their development of the first rapid COVID-19 diagnostic test able to be performed fully at home, with no laboratory involvement. The antigen test, developed by Cellex, requires its user to take a nasal swab from both nostrils and then place the swab in a small vial filled with a buffer solution. An AI app, developed by Gauss, then analyzes a picture of the rapid test to deliver results within 15 minutes. The test is still under development, and the companies will be pursuing US Food and Drug Administration emergency use authorization in upcoming months with the hopes of making the tool “as widely available as possible.”Preliminary results from a 1,000-person study indicated positive results for Eli Lilly’s anti-inflammatory treatment in shortening COVID-19 recovery time. The study, sponsored by the National Institute for Allergy and Infectious Diseases, tested Eli Lilly’s rheumatoid arthritis drug baricitinib in combination with Gilead’s remdesivir, which has previously been shown to reduce COVID-19 recovery time. The results announced last week, which have not yet been published or reviewed by independent scientists, showed participants given baricitinib recovered one day sooner than those given remdesivir alone. Eli Lilly plans to pursue emergency use approval of the drug for hospitalized COVID-19 patients and, if approved, proposes selling it through its normal commercial means.

The COVID-19 pandemic has revealed a collective failure to take pandemic prevention, preparedness, and response seriously and prioritize it appropriately, according to a report released this week by the Global Preparedness Monitoring Board (GPMB)—an independent panel co-convened by the World Bank and World Health Organization (WHO) to offer policy recommendations on pandemic preparedness. As a result, the world is paying a hefty price in economic and health losses, the report stresses. Vaccination campaigns around the world have been suspended, threatening polio eradication and potentially leading to new outbreaks of preventable diseases. Interrupted access to HIV/AIDS, tuberculosis, and malaria care threatens to cause more than 1 million additional deaths in 2020-2021 alone. Meanwhile, the costs of this pandemic have already been measured in the trillions of dollars, while the costs of preparedness are billions. GPMB representatives have noted it would take 500 years to spend as much on investing in preparedness as the world is losing due to COVID-19. In their inaugural report last year, GPMB stressed the inadequacy of systems and financing required to detect and respond to health emergencies. As COVID-19 has proven, these systems remain dangerously deficient and under-resourced. This year’s report, “A World in Disorder,” highlights five calls for urgent action: 1) responsible leadership; 2) engaged citizenship; 3) strong and agile national and global systems for global health security; 4) sustained investment in prevention and preparedness, commensurate with the scale of a pandemic threat; and 5) robust global governance of preparedness for health emergencies. Three of the five recommendations connect to strengthening the global health research and development (R&D) ecosystem.  A call for strong and agile national and global systems for global health security In its 2019 report, GPMB called on heads of government to “appoint a high-level coordinator and invest in research and development for countermeasures and non-pharmaceutical interventions, along with mechanisms for sharing genome sequences of new pathogens, and for equitable allocation of scarce medical countermeasures.” The need for this has been apparent throughout the COVID-19 pandemic, as uneven and uncoordinated responses have hampered efforts to flatten the curve.  This year’s report doubles down on the need for greater coordination and highlights the need for formal global mechanisms to facilitate the development, assessment, and distribution of diagnostics and medical countermeasures. The following recommendation and the supporting points underscore this priority: “Urgent action: Researchers, research institutions, research funders, the private sector, governments, the World Health Organization and international organizations improve coordination and support for research and development in health emergencies and establish a sustainable mechanism to ensure rapid development, early availability, effective and equitable access to novel vaccines, therapeutics, diagnostics and non-pharmaceutical interventions for health emergencies, including capacity for testing, scaled manufacturing and distribution.” Progress has been made on a coordinated R&D response but remains fragile. Scientists and researchers around the globe have raced with record speed to develop and assess countermeasures. This progress is based on past investments and existing infrastructure for basic research, as well as new frameworks and initiatives, including the Access to COVID-19 Tools (ACT) Accelerator, which highlights the need to work more collaboratively not just across different geographies, but with the end-to-end process in mind. Yet GPMB highlights that it remains to be seen whether these initiatives can deliver on their promise, or whether they will expand their scope beyond the current pandemic. What is certain is that if these endeavors are to be successful, they will need serious investment. ACT Accelerator partners estimate they will need US$35 billion to fund this initiative, of which $15 billion is needed by the end of this year. GHTC has been working diligently behind the scenes with government, private sector, and civil society stakeholders to push for greater collaboration, ensure world leaders leverage these mechanisms in the future, and use the current focus on the pandemic to establish more sustainable financing mechanisms for R&D to confront future health threats. Global preparedness is not simply the sum of national preparedness. The GPMB report highlights the need for global agreements or mechanisms to share information and allocate limited supplies of countermeasures. The expert panel notes that while “national preparedness is key, global and regional mechanisms for tracking potential pathogens, early alert, information sharing, research and development, regulatory capacity-building and harmonization, allocation of countermeasures, stockpiles and supply chains must also be strengthened and developed, sustained and financed. Preparedness to conduct rapid research and countermeasure development requires sustained commitment to capacity-building and funding for basic science research.” Past pandemics have shown that without clear frameworks and procedures to facilitate the equitable sharing of limited medical countermeasures, low and middle-income countries (LMICs) may be unable to secure access to the innovative medical products they need. GHTC believes that as instruments such as the COVID-19 Global Vaccine Access (COVAX) Facility are stood up, it is important to ensure that the world leaders look beyond the current pandemic and establish sustainable mechanisms that will outlast COVID-19 to support the range and scope of R&D necessary to confront health emergencies in the future. Manufacturing capacity, stockpiling, and supply chains have become major bottlenecks. When COVID-19 struck, most countries did not have sufficient stockpiles of medical countermeasures or the pre-existing capacity and resources to suddenly scale up manufacturing to respond to a pandemic. This created a major surge in global demand and exposed the fragility of global supply chains for medical goods. In LMICs that cannot afford bidding wars, it has been extremely challenging to source personal protective equipment, testing materials, treatments, and medical equipment. Over the past decade, the manufacturing of vaccines, therapeutics, and diagnostics has become increasingly concentrated in a few countries, which has exacerbated the risk of ruptures and has proven detrimental to the equitable distribution of health products. This shortage of manufacturing capacity for medical countermeasures has threatened countries’ capacities to fight COVID-19.  A global coordination mechanism can support regional capacity building in LMICs. GHTC is urging world leaders to create a global institution or broaden the mission of an existing mechanism like the Coalition for Epidemic Preparedness Innovations (CEPI) that can coordinate and galvanize biomedical research expertise and advance health products to respond to emerging health threats. This institution should also work closely with countries to improve regional capacity, provide technical assistance, and highlight where there may be a need for additional strategic investments to support preparedness capabilities.  A need for sustained investment in prevention and preparedness, commensurate with the scale of a pandemic threat As seen previously with Ebola, and now with COVID-19, the cost of response is far greater than preparedness due to massive economic disruption caused by pandemics. It also demonstrates the urgent need for global financing mechanisms to accelerate national health preparedness and prevention capacity, including for biomedical research, development, and manufacturing. The GMPB report follows the calls of many experts, articulating the need for new health security financing incentives and investment accountability. The following recommendation from the report highlights the need for international financing for R&D: “Urgent action: The World Bank and other International Financial Institutions (IFI) make research and development (R&D) investments eligible for IFI financing and develop mechanisms to provide financing for global R&D for health emergencies.” Extraordinary events require extraordinary financing. The world urgently needs a robust, dedicated global health security funding mechanism to catalyze and accelerate the necessary investments that will help prevent the next pandemic. The GPMB expert panel argues in its report that rapid financing of emergency R&D and capacity-building is hampered by the lack of mechanisms in IFIs to provide such financing at the global level. Many experts believe that new mechanisms are needed, and some— including GHTC—believe that the World Bank’s Health Emergencies Preparedness and Response Fund (HEPRF) can fill that role by financing some short-term R&D capacity-building programs. This includes rapidly increasing regional diagnostics manufacturing and laboratory capacity, expanding clinical trial capabilities in LMICs for COVID-19 health products, and supporting regional regulatory processes to speed the uptake and use of these new technologies. Advocates have also pushed for innovative financing models such as a Global Health Security Challenge Fund to close the massive global gaps in pandemic preparedness.  Robust global governance of preparedness for health emergencies is vital for global security COVID-19 has highlighted significant gaps in the governance of preparedness. Key issues have arisen around the functioning and implementation of the International Health Regulations (IHRs), which countries have committed to meet, and our current mechanisms are inadequate to fully respond to the crisis or help catalyze and coordinate R&D for medical countermeasures. The GPMB recommendation below highlights the need to galvanize world leaders to develop a new governance framework for global preparedness through a United Nations (UN)–led forum: “Urgent action: The Secretary-General of the United Nations, the Director-General of the World Health Organization, and the heads of International Financing Institutions convene a UN summit on Global Health Security, with the aim of agreeing on an international framework for health emergency preparedness and response, incorporating the IHR, and including mechanisms for sustainable financing, research and development, social protection, equitable access to countermeasures for all, and mutual accountability.” Current measures of preparedness are not predictive. The GPMB expert panel asserts that our understanding of preparedness is based on a narrow set of public health capacities that does not fully capture the range of national and international capacities necessary to ensure preparedness, including R&D, measures to mitigate the socioeconomic impacts of epidemics and ensure continuity of essential services, international cooperation, and the preparedness of international organizations. This underscores a problem GHTC has raised for several years, namely that while it has never been more apparent that R&D for health technologies and medical countermeasures is vital to enhance our capacity to prevent and combat threats as they emerge, capacity-building of R&D for medical countermeasures including diagnostics is noticeably absent from IHRs and the Global Health Security Agenda. In order to address current and future pandemics, it will be essential to ensure that R&D is integrated formally into both. While not every country needs a full suite of R&D capabilities for vaccines, diagnostics, therapeutics, and other technologies like personal protective equipment and oxygen therapies, GHTC believes every country should have a plan and pathway to gain access to these tools at an affordable price when needed. Final thoughts: GPMB highlights that the pandemic is a stress test for global solidarity and multilateralism One of the greatest challenges of the COVID-19 pandemic is faltering multilateral cooperation. While a plethora of new initiatives have emerged to combat the coronavirus, nationalistic attitudes and political tensions have hampered the global response. We have seen this year that disagreements over the adequacy of WHO’s response to the pandemic, as well as continued diplomatic strife between the United States and China have complicated the implementation of a collective response and stalled progress in the G7 and G20, with both fora failing to develop or publish strong consensus resolutions or roadmaps. The report makes it quite clear that we are at a fork in the road when it comes to this crisis. We can either choose to take bold collective action and strengthen the multilateral system, with a strengthened focus on gaps like R&D capacity, or retreat into nationalism. COVID-19 will remain a protracted crisis without global collaboration, and now is the time to strengthen the global health security R&D architecture of the future to ensure that we are prepared for the next pandemic.