Julien Rashid

COVID-19 is an unprecedented global health crisis. Just as every sector is grappling with unforeseen challenges, global health advocacy has been continuously adapting to a policy environment in flux. As part of this community, the Global Health Technologies Coalition (GHTC) has been responding by:Reporting on the latest developments in COVID-19 research and development (R&D).Tracking COVID-19’s impacts on the R&D ecosystem.Sharing key US and multilateral policy updates with our members and partners.Developing and advancing specific policies that would drive creation of new tools for countering COVID-19 in low-resource settings, especially in low- and middle-income countries (LMICs).GHTC applauds many of the actions taken by lead US policymakers over the last several months. Congress has appropriated more than $10 billion for research to respond to COVID-19 through four emergency supplemental bills, and this funding is driving high-impact innovation at record speed. Yet many of the new products that result from this innovation will be ill-suited for low-resource settings, which often lack electricity, adequate hygiene, highly trained health care workers, laboratory networks, robust supply chains, and other attributes often taken for granted in well-resourced systems. For these settings, we need different innovations:Drugs that are easily transported and administered without the need for highly trained health workers.Rapid diagnostic tests that can deliver results at point of care without using complex laboratory equipment.Vaccines that are single dose, can be stored at room temperature, can be rapidly produced and distributed, and are easily administered (ideally through ingestion, a patch on the skin, or an electrical pulse rather than an injection). Medical devices, such as specially designed non-invasive ventilators, IV infusion monitors, and oxygen delivery devices, that require minimal technical expertise, have fewer and more easily replaceable parts, are quickly manufactured, and are battery operated.Personal protective equipment that is durable, reusable, open-source, and can be quickly manufactured and adapted in a variety of settings.Through our US and multilateral policy efforts, GHTC has been advocating for policies that would foster these needed products. In our US advocacy, we are pushing Congress for three funding lines that would drive innovation at the US Agency for International Development (USAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Centers for Disease Control and Prevention (CDC):$200 million for Global Health Programs at USAID to advance and deliver innovations to help LMICs prevent, prepare for, and respond to COVID-19 and other pandemic threats. These innovations should be specifically designed for low-resource settings and should include vaccines and vaccine delivery systems; diagnostics; therapeutics; medical devices; personal protective equipment for frontline health workers; health facility innovations; and the financing, manufacturing, and delivery systems these essential resources require.At least $200 million to CEPI to advance vaccine candidates for SARS-CoV-2. CEPI is advancing nine vaccine candidates and has put forward a $5 billion global ask to advance this portfolio. US support for CEPI will help ensure that vaccines developed will be deployed effectively and affordably worldwide.Robust funding for the CDC Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases to support the development and deployment of essential tools to combat COVID-19 globally.In our multilateral advocacy, GHTC has been pushing back against the United States’ retreat from international leadership on COVID-19 R&D, including the decision to withdraw from the World Health Organization (WHO) in the middle of the pandemic. GHTC advocates that the United States should work with other global leaders to proactively invest in global product development, manufacturing capacity, and product delivery mechanisms, including the Access to COVID-19 Tools (ACT) Accelerator, which could be instrumental in helping LMICs finance the purchase and administration of COVID-19 vaccines, treatments, diagnostics, and other tools. GHTC has also been pushing other G7 and G20 leaders to fill the funding gaps for the ACT Accelerator and to support other financing mechanisms such as a World Bank global health security challenge fund and health systems strengthening investments by regional development banks.GHTC is also engaging with the Global Health Security Agenda (GHSA) and pushing for the explicit inclusion within GHSA of R&D for diagnostics and medical countermeasures to respond to emerging health threats.Finally, GHTC has been working with other global stakeholders to assess how new COVID-19 product development and deployment mechanisms could be used to reshape the global R&D ecosystem and benefit other critical global health priorities.To support our US and multilateral policy asks, GHTC is tracking US government and multilateral-supported COVID-19 R&D, publishing materials to help policymakers and the public better understand these research efforts, and leading and supporting our partners with aligned messaging:GHTC COVID-19 R&D Tracker [Editor note: This was discontinued in 2021]COVID-19 Vaccine 101: The Facts that MatterGHTC maps the US agencies involved in Global Health Security R&DGHTC-led Congressional letter to support R&D for the international responseGHTC featured in Global Citizen: “To Defeat COVID-19, the United States Must Invest in Innovations for All”GHTC defends WHO’s role in global R&D response to COVID-19GHTC condemns US withdrawal from WHOGHTC endorses FIND’s Call to Action on COVID-19 testingThis is the first global health crisis in this century to significantly affect every person living in the United States and around the world—a catastrophe that could raise awareness and support for global health R&D. GHTC will continue to leverage this moment and emphasize the narrative that links all the issues we work on, that global health and global health security can never be assured until we have a robust, coordinated, and global R&D ecosystem that includes the populations, diseases, and conditions too often overlooked.

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. The US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.

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.Dexamethasone, an inexpensive, decades-old drug is showing promise for treating COVID-19, per unpublished, preliminary results from a study called Recovery that was funded by the United Kingdom. The preliminary results indicated that the drug reduced the risk of death for patients on ventilators by 35 percent, those receiving oxygen by 20 percent, and overall mortality by 17 percent. Immediately following the results, the United Kingdom granted approval for use of the drug to treat COVID-19. According to FiercePharma, UK officials have enough dexamethasone stockpiled to treat 200,000 patients.  A recent study lends support to anecdotal evidence that blood type and genetics may be linked to worse outcomes from COVID-19 illness. Last Wednesday, a team of European researchers published a study in The New England Journal of Medicine indicating that people with type A blood have a 45 percent higher risk of catching COVID-19 and sliding into respiratory failure and people with type O blood have a 35 percent lower risk of developing respiratory failure compared to people with other blood types. Scientists are still unsure why blood type might be correlated with COVID-19 outcomes, but a nascent hypothesis is that it could be linked to blood clotting risk. The researchers also found that a cluster of genes are associated with higher risk of developing severe COVID-19 by 77 percent.A project led by researchers from Scripps Research, GHTC member IAVI, and the University of California San Diego School of Medicine published research in Science detailing a set of antibodies discovered in recovered COVID-19 patients that provide powerful protection against SARS-CoV-2. In theory, the antibodies could be given to patients who are just developing the illness to prevent progression to severe disease and to protect people who are at higher risk for contracting COVID-19. To discover the antibodies, the scientists isolated more than 1,000 distinct antibody-producing immune cells, obtained genetic sequences from these cells to produce more antibodies, and then tested the antibodies’ effectiveness against blocking the virus in vitro. The researchers discovered several antibodies that, even in small quantities, could block the SARS-CoV-2 virus. The work was funded by the US National Institutes of Health, IAVI, and the Bill & Melinda Gates Foundation, among others.

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.The Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA) will partner with SiO2, an advanced materials science company, to introduce a novel technology for packaging COVID-19 vaccines and other pharmaceuticals. JPEO-CBRND and BARDA will provide US$143 million in funding to scale production of the company’s new technology that includes a plastic container with a microscopic glass coating. The product is thermal stable (range of -196 C to 121 C), highly durable (able to withstand 1,500 pounds of direct force), and precision molded, making it more dimensionally consistent than glass vials.The vaccine candidate, mRNA-1273, developed by the National Institute of Allergy and Infectious Diseases in partnership with Moderna, will begin phase 3 clinical testing by July, followed in August by Oxford University/AstraZeneca’s vaccine, and in September by Johnson & Johnson’s vaccine. All three companies are backed by the US government as part of Operation Warp Speed, and each is testing new technology.On Monday, an official from the World Health Organization (WHO) suggested that spread of COVID-19 by people who are asymptomatic is “very rare,” but clarified on Tuesday that scientists are actually unsure how frequently asymptomatic spread occurs. The initial comments caused a stir among public health experts, some labelling the comment as miscommunication. Underlying the confusion is that the term “asymptomatic” can mean either people who are presymptomatic or people who develop a full infection without showing symptoms. There is some evidence that fully asymptomatic cases may not be very contagious, while other studies show that patients may be most contagious when they are presymptomatic. Either way, experts note, individuals without symptoms should still be taking precautions.

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 part of Operation Warp Speed, the Trump Administration has selected five top COVID-19 vaccine candidates to receive priority government support. The candidates include mRNA-1273 (Moderna and the National Institute of Allergy and Infectious Diseases), AZD-1222 (AstraZeneca and Oxford University), Ad26 SARS-Cov-2 (Johnson & Johnson), and candidates from Merck/IAVI and Pfizer. The Merck/IAVI and Pfizer candidates have not yet received federal funding, but as selected companies, they will receive access to government support to advance their programs. The mRNA-1273 and AZD-1222 candidates are already in phase 2 clinical trials and are expected to reach phase 3 in July. Officials anticipate that each vaccine will be tested on 30,000 individuals in phase 3 trials, some of which may take place outside the United States. An official announcement about the selection of these five companies is expected from Operation Warp Speed in the next few weeks.Convalescent plasma, sourced from patients who have recovered from COVID-19, did not demonstrate significant effectiveness as a treatment in the first randomized clinical trial evaluating its use. The Wuhan-based trial, however, fell short of its target recruitment because of containment of the outbreak and only enrolled 103 of the 200 patients needed to demonstrate a clinically meaningful result. In the same journal, Dr. Arturo Casadevall of the Johns Hopkins School of Public Health said that, though there was no significant improvement, the study gave “potentially hopeful signals” and that convalescent plasma should be tested in combination with antiviral drugs.The World Health Organization (WHO) launched at the end of May the COVID-19 Technology Access Pool, or C-TAP, a global project to share intellectual property and speed the research, development, and deployment of new vaccines, tests, treatments, and other health tools for COVID-19. The voluntary pool was initiated by Costa Rica and is supported mostly by low and middle-income countries and only a few high-income countries. Notably, many countries that are leading the research race for new tools, including the United States, the United Kingdom, France, Germany, and Switzerland, have not supported C-TAP. Meanwhile, some leaders from the pharmaceutical industry have dismissed the project while other groups, such as the Médecins Sans Frontières’ Access Campaign, have given praise.

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. Merck and GHTC member IAVI are joining forces to develop a COVID-19 vaccine candidate based on the rVSV platform, the same one under the hood of the ERVEBO Ebola vaccine approved last year by the Food and Drug Administration. The Biomedical Advanced Research and Development Authority announced it will back the project, making it the fifth COVID-19 vaccine candidate in the agency’s portfolio. The rVSV platform typically takes longer to develop than other methods but can lead to a product that creates a robust immune response from a single dose. IAVI has used the rVSV platform in efforts to develop vaccines against HIV, Lassa fever, and Marburg virus. The vaccine development race could turn into a story of global cooperation or global competition. Unfortunately, the United States and China are increasingly at heads, as both nations’ presidents look to vaccine success at home to soften criticism of their countries’ early response. President Trump has launched Operation Warp Speed to deliver a vaccine for Americans as quickly as possible. Meanwhile, President Xi Jinping hopes a first-to-market Chinese vaccine could boost ambitions for China to be a 21st century world leader in biopharmaceuticals and serve as form of “vaccine diplomacy.” With a global problem, a global solution is needed—but with the time it takes to manufacture vaccines, a waiting line will inevitably form, raising questions of which countries will get vaccines first. “It's set up to be a massive geopolitical battle,” said Ian Bremmer, president of the Eurasia Group, “not just around the discovery of the vaccine, but the manufacturing chain — with billions of doses needed, and the challenges of a global vaccination campaign.” COVID-19 is transforming the biomedical research and development ecosystem and accelerating emerging approaches, including real-time data sharing, drug repurposing, regulatory harmonization, and public-private collaboration, according to the founding partners of a new COVID-19 research consortium. The author points out that long hoped for tools—such as modernized regulatory science, digital medicine technologies, and adaptive clinical trial design—are being used to accelerate approvals of new medicines, diagnostics, and vaccines against COVID-19 and are moving us closer to an imagined future faster than expected.