Breakthroughs Blog: Access

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.Seventy-five countries submitted expressions of interests to join the COVID-19 Vaccine Global Access (COVAX) Facility, a new initiative to ensure fair and equitable vaccine distribution around the world. The 75 interested countries would fund vaccine production and distribution through their national budgets, supporting vaccine access among their own populations as well as in 90 lower-income countries through voluntary donations. COVAX would provide a guaranteed share of vaccine doses to cover 20 percent of each country’s population and act as a supplement to any deals individual countries make with vaccine manufacturers. The COVAX Facility is a key part of the Access to COVID-19 Tools (ACT) Accelerator vaccine pillar, which is led by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO). The initial goal of the initiative is to raise US$2 billion to buy COVID-19 vaccines, according to Gavi. More than 100 COVID-19 vaccine candidates are currently in development around the world.In an open letter to National Institutes of Health (NIH) Director Francis Collins, more than 100 scientists called for human challenge trials to accelerate the development of a COVID-19 vaccine. During challenge trials, healthy volunteers are given a vaccine and then exposed to a virus to evaluate whether the vaccine prevents infection. While challenge trials are controversial, they would hasten the COVID-19 vaccine development process, as conventional efficacy trials can take months longer. Signatories of the letter also noted that challenge trials are more likely to yield interpretable results. Some US lawmakers already support the idea, and WHO guidance has stated that human challenge trials are ethical when in compliance with certain criteria.The Foundation for Innovative Diagnostics (FIND)—a GHTC member—and Cepheid, Inc., announced last week the launch of a new rapid molecular tuberculosis (TB) test that can simultaneously detect first- and second-line drug resistance. The Xpert® MTB/XDR test can provide TB drug-resistance profiles in less than 90 minutes and could be crucial in the fight against extensively drug-resistant TB (XDR-TB), the most complicated form of TB. Current methods for identifying drug-resistance profiles for XDR-TB can take up to 16 weeks to give results. Diagnosis and treatment of drug-resistant TB has been an essential part of TB elimination efforts for years. FIND and Cepheid have both conducted evaluations on the new test, and the data will undergo WHO review later this year. 

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. The National Institutes of Health has launched a large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB). The study is comparing the safety and efficacy of a newer TB drug delamanid—one of the first drugs available specifically to treat MDR-TB and the first to exist in a child-friendly formulation—with isoniazid, a decades-old drug for TB prevention, in preventing development of active MDR-TB among high-risk individuals exposed to household members with MDR-TB. Study participants are considered at high risk if if they have latent TB infection, suppressed immune systems from HIV or other factors, or are younger than five years old. Study investigators hypothesize that delamanid will be a better prophylactic treatment than isoniazid in reducing the likelihood that at-risk household members of individuals living with MDR-TB will develop active TB. Existing treatments for MDR-TB are often toxic, poorly tolerated, expensive, and aren’t always available. The World Health Organization (WHO) estimated 460,000 people worldwide developed MDR-TB in 2017. According the Access to Medicine Index issued last month, which ranks the world’s 20 largest pharmaceutical companies on their efforts to improve access to medications for the world’s poorest, the industry has made remarkable progress in increasing access to lifesaving medicines, through efforts like drug donation and licensing patents to generic producers. However, according to the report, most of the progress made by the industry is limited to a few companies with their efforts too reliant on donor dollars. GSK has ranked first every year since the rankings began, with its score steadily rising each year. Dr. Jayasree K. Iyer, executive director of the Access to Medicine Foundation which releases the index, stated that two billion people still lack access to the products they need, implying progress on access has just begun. A new, rapid diagnostic test that can detect yaws—a debilitating bacterial disease spread through skin-to-skin contact causing skin lesions and ulcers—may reinvigorate efforts to eradicate the disease which affects thousands of the world’s poorest children. The molecular diagnostic test costs just US$2 and can detect yaws within 30 minutes at point-of-care, eliminating the time-consuming need to transfer disease samples to expensive high-tech labs. Though WHO reported more than 80,000 suspected cases of yaws in 2018, the real number of infections is likely to be much higher. The rapid diagnostic test is one of 30 finalists of the WHO Innovation Challenge and was showcased at the Africa Health Forum earlier this year. The diagnostic has shown “impressive results” in small trials, according to its creator, who is looking to do larger scale testing.

Against a backdrop of mounting global health challenges, the 72nd World Health Assembly (WHA) convened last week, with politicians, philanthropists, business executives, and civil society leaders all descending upon Geneva. GHTC was on the scene—attending side events, technical briefings, and following the official agenda. Here are our top four takeaways from this year’s assembly:1. Universal Health Coverage (UHC) dominates WHA.Considered the theme of this year’s WHA and a core component of the platform of the World Health Organization (WHO) Director-General, UHC was a ubiquitous topic in Geneva as stakeholders prepare for the United Nations (UN) High-Level Meeting on UHC in September. Multiple side events and briefings focused on the topic with discussions yielding numerous calls to action from bolstering the inclusion of low- and middle-income country (LMIC) voices, to investing in community health workers, to making primary health care the central pillar of UHC. During the official WHA sessions, there was also strong consensus around the importance of leaving no one behind, equity in health, and a people-centric approach to UHC. The hotly anticipated zero draft of the Political Declaration of the High-level Meeting on UHC was also released last week. The draft is meant to serve as a baseline for members states who will ultimately endorse a political declaration at the high-level meeting this fall and reflects some of the feedback that civil society provided during the consultative process. The document features some encouraging language on health research and development (R&D): calling for improved availability, access, and affordability of quality medicines, vaccines, diagnostics, and other health technologies, and it encourages incentives for R&D, including stronger public-private partnerships. The draft also underlines the importance of investment in new health technologies.While the R&D community can be heartened by these inclusions, there are notable omissions. There was no direct mention of specific diseases affecting vulnerable populations in LMICs and no specific request or direct call for increased investment in R&D for new health tools.2. Contentious access debate at WHA ends with compromise resolution on drug and health product price transparency.Advocates anticipated that the access to medicines issue would be the one of the most contentious topics at this year’s WHA. They were right.After long and arduous negotiations which delayed the access to medicines session by several days, member states adopted a compromise resolution at WHA urging greater transparency on drug prices. The resolution calls on members to “take appropriate measures to publicly share information on the net prices of health products.” The most contentious element of the initial draft, which urged disclosure of R&D costs, particularly for clinical trials, was ultimately amended to feature language emphasizing the purely voluntary nature of those disclosures. While the resolution was celebrated as a landmark by the WHO Director-General, many member states were unhappy with the process, with Germany, the United Kingdom, and the United States expressing their discontent with the approach and timing.3. Ebola crisis keeps emergency preparedness at the top of the agenda.The worsening Ebola crisis in the Democratic Republic of the Congo loomed large at WHA, as tributes to health workers were featured throughout the proceedings. There was a common refrain during the week about the need for improved coordination in emergency preparedness between global actors and local communities, with many delegates from the global south, including WHO Director-General Dr. Tedros himself, emphasizing the importance of building trust and integrating community health workers in the process. From an R&D perspective, many stakeholders called for strengthening in-country capacity, including laboratory and clinical trial capacity, as an integral pillar of developing effective countermeasures.To better support member states in improving preparedness, WHO set up a new division specifically for emergency preparedness, as part of its reform process earlier this year, which will work in tandem with its existing workstreams on emergency response. WHO also welcomed the appointment of a UN emergency Ebola response coordinator to facilitate interagency activities. 4. Follow-up meeting to the UN High-Level meeting on Tuberculosis (TB) shows promise with accountability as key.Several sessions at WHA focused on the follow-up to previous political commitments, including the declaration from the UN High-Level Meeting on TB. It was encouraging to hear the United States, several members of the European Union, and a few other member states call for additional R&D to combat TB and underscore the need to develop new drugs and vaccines, scale up diagnostic capabilities, and invest in innovative technologies.WHO also released a multisectoral accountability framework to accelerate progress to end the TB epidemic, which was previously requested in 2018 by the WHA and the UN General Assembly. Several countries, including the United States, endorsed the framework during the official session, and WHO is looking to facilitate its adaptation and use by member states and their partners at country, regional, and global levels throughout 2019. This year’s WHA cemented the need for new approaches, partnerships, and models in order to deliver on many of the promises that were made as part of the 2030 agenda. The next few months will see a continuation of advances on the UHC agenda, movement on WHO reform, and implementation of newly adopted resolution and political commitments.