Breakthroughs Blog: COVID-19

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.

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.In its largest award to date, the Biomedical Advanced Research and Development Authority announced it will put US$1.2 billion behind the ChAdOx1 vaccine candidate, now known as AZD1222, which was invented at the University of Oxford Jenner Institute and was recently licensed to AstraZeneca for further development. This award will fund phase 3 clinical trials to begin this summer with 30,000 US volunteers and scaled-up manufacturing. The vaccine is currently being tested on 1,000 volunteers in England in phase 1/2 clinical trials. The award is part of Operation Warp Speed, the recently launched US government endeavor to make 300 million doses of a SARS-CoV-2 vaccine available by January 2021. Scientists at the Jenner Institute developed ChAdOx1 with support from US government scientists at Rocky Mountain Laboratories, part of the National Institute for Allergy and Infectious Diseases (NIAID), who performed preclinical efficacy testing with the vaccine on rhesus macaques.Moderna released interim phase 1 clinical trial results for its mRNA-1273 SARS-CoV-2 vaccine candidate, which is backed by NIAID. The results, from a NIAID-led trial, found that eight volunteers developed neutralizing antibodies to COVID-19 after receiving two-dose versions of the candidate vaccine at different dose levels. Those who received two lower doses (25 micrograms) developed antibodies commensurate to people who have recovered from the disease, while those who received two higher doses (100 micrograms) developed antibodies significantly exceeding levels of people who have recovered. It’s not yet clear whether these antibodies provide protection, and some experts have tried to temper enthusiasm around the news, noting that Moderna revealed too little information to conclude whether the candidate holds promise.The Chinese government is working to fast-track promising COVID-19 vaccine projects. It has at least four candidates in clinical development funded mostly by its Ministry of Science and Technology. Fast-tracking candidates, however, may come at a cost. Domestic public confidence in Chinese made vaccines is low and was dragged down in 2018 after a Chinese company falsified production records for a rabies vaccine and sold more than 250,000 doses for infants that didn’t meet medical standards. Still, experts say that the Chinese government sees a vaccine as critical for public health and reigniting a strong economy, If China develops the world’s first vaccine, President Xi Jinping has promised to share the vaccine with the rest of the world. Doing so could help the government deflect global criticism of its early response to the outbreak and provide propaganda in favor of China’s authoritarian political structure over Western models.

The COVID-19 pandemic is a wake-up call for multilateralism. As leaders from around the globe convened for the first-ever virtual World Health Assembly (WHA), it has never been clearer that every country has been touched by this horrible disease, as evidenced by delegates highlighting their countries’ actions and response efforts in their interventions. The COVID-19 crisis has demonstrated just how crucial multilateral conveners like the World Health Organization (WHO) are to our collective health, prosperity, and security and the need for enhanced international cooperation and worldwide solidarity. Innovation is our exit strategy for defeating COVID-19 and combating the pandemic calls for a robust, coordinated, large-scale, and science-based global response. Governments and foundations are pouring billions into scientific research efforts to develop new tools to detect, treat, and prevent COVID-19. Yet these new initiatives and efforts need to be aligned. The World Health Organization (WHO) has been called on to coordinate several of the R&D response efforts to accelerate the development of diagnostics, vaccines, therapeutics, and other health technologies to combat this novel coronavirus, and the organization’s ability to effectively help support these efforts will be vital to their success. Accelerating research to develop new tools The global response will have to be well coordinated. With so many new mechanisms being developed to fight COVID-19, it is essential to ensure that efforts are not counterproductive. It will also be important that there is a holistic approach to tackling this crisis because there will be no silver bullet.  We can start with WHO’s creation of COVID-19 Target Product Profiles (TPPS), which outlines the product gaps to be filled. Building on that, WHO launched a new program, called the Access to COVID-19 Tools Accelerator, or the ACT Accelerator. This collaboration between WHO and dozens of governments, nonprofit organizations, and industry leaders seeks to facilitate partnerships, provide technical guidance, and provide support to health systems and strengthen countries' capacities to enable the delivery of new COVID-19 tools. The global initiative will draw on the expertise and infrastructure already put in place by organizations that work across the globe, including Gavi, the Vaccine Alliance; CEPI, the Coalition of Epidemic Preparedness Innovations; FIND; the Global Fund; and Unitaid. Speed is a key factor to quelling the pandemic. As scientists around the world race for a cure for COVID-19, international cooperation is critical for accelerating research. One of the ways WHO has supported these efforts is by designing a large international randomized controlled clinical trial, called the Solidarity Trial, to enable the simultaneous evaluation of the benefits and risks of different vaccines at sites with sufficiently high rates of the disease. This will ensure a faster turnaround of results and ensure that sufficient data is being captured to make more robust assessments of the efficacy and safety of these treatments. While the trial is currently only being leveraged for the most severe cases, with few trials in resource-poor settings, this approach should be broadened and connected to initiatives like the COVID-19 Clinical Research Coalition in order to have a more complete assessment of how R&D treatments for COVID-19 are progressing. Assessing new technologies quickly will also be a major factor in how rapidly they can be deployed. In order to ensure quick access to high-quality, safe, and effective new health technologies for COVID-19, WHO has activated its Emergency Use Listing (EUL), a procedure that allows for rapid assessment of diagnostic and labrotary technology. This is crucial for countries that have weaker regulatory systems or  lack local infrastructure such as laboratory capacity to evaluate new tools. EUL helps accelerate access to these innovations, but this should only be the first step. Beyond emergency approvals, full technology assessments such as the WHO Prequalification process should also be leveraged as new products are realized. For example, we saw the new Ervebo Ebola vaccine go through WHO Prequalification within 48 hours of the European Medicines Agency’s recommendation, and GHTC would like to see that approach  mirrored for products developed to respond to COVID-19 as well as other health threats. Tackling supply challenges and access What happens once vaccines, treatments, diagnostics, and other technologies receive emergency use authorization or full regulatory approval? A global pandemic means these life-saving tools have unprecedented global demand with herculean scale-up requirements. Manufacturing could be slow, expensive, and vulnerable to export controls. We have already witnessed conflicts over raw materials and reagents for diagnostics, and meeting global demand for a COVID-19 vaccine would require an unprecedented effort to utilize the world’s current capacity to produce, package, and deliver these products. Countries like China and India control major stakes in supply chains for active pharmaceutical ingredients, glass vials, and adjuvants. These challenges represent a significant threat to lower-income countries as they may be unable to access scarce medical technologies or component parts if wealthy countries dominate the global bidding wars for essential equipment. Some countries will also be unable to administer and scale-up the response on their own and will need support in building the health systems and managing the supply chains required to provide access to these life-saving tools. WHO has already started working on ways to ensure that key technologies and equipment will be available to frontline health workers and the most vulnerable populations, helping marshal essential resources and equipment, and looking for ways to secure the supply chain for key medical products. Service delivery systems need to be strengthened with the support of international donors, and new commitments and resources should be made to existing global health mechanisms like Gavi, the Vaccine Alliance, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Access was also a central focus of the European Union led resolution on COVID-19 that was adopted at the virtual WHA. It included far-reaching provisions, including the creation of a voluntary pool of patents for COVID-19 treatments and language highlighting the rights of countries to legally override international patent rules during a health emergency. While some of the specific items remain hotly debated, it is clear that there is a growing consensus that more needs to be done to ensure equitable access for safe, quality, effective, and affordable COVID-19 diagnostics, therapeutics, and vaccines to ensure that in the fight against COVID-19, no one is left behind. Global response and scientific research hampered by politics While it is clear that a global approach is crucial to stemming the worldwide spread of the disease, global cooperation has been strikingly absent in many multilateral forums, including G7, G20, and WHA. The rift between China and the United States endures, and this tension was also on full display during WHA. While many countries reiterated their support for WHO, the US took a different approach, delivering a fiery rebuke of the organization and accusing WHO of failures in responding to the pandemic while also alleging that China was not open and transparent at the outset of the crisis. Coupled with President Trump’s continued threats to cut funding to the organization, key functions of WHO in responding to the pandemic are in jeopardy. It will be paramount in the coming weeks that leaders push to ensure that key initiatives being led by WHO are not derailed.  They must be able to continue their work supporting response efforts and coordinating disease incidence surveillance and COVID-19 R&D efforts around the world. The role WHO is uniquely qualified to play WHO is uniquely qualified to coordinate global research and development efforts, marshal equitable allocation of resources, and provide technical guidance to fight the pandemic. We know this pandemic will not be the last. The important question now is whether the battle against COVID-19 will strengthen or exhaust our ability to respond again in the future. While this crisis presents unique challenges, it also presents the world with an opportunity to reimagine the architecture of global health systems including new ways to advance and coordinate R&D to address future health threats in a more holistic and sustainable way. Now more than ever, leaders from around the world must look to our multilateral institutions like WHO to drive the global effort that is required to develop the health technologies we need to defeat the coronavirus and enhance our global health security capacity to respond to future outbreaks.

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. US science leaders, including Dr. Lawrence Corey of the Fred Hutchinson Cancer Research Center, Dr. John Mascola and Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, and Dr. Francis Collins, director of the National Institutes of Health, penned an article in Science Magazine, emphasizing that “the global need for vaccine and the wide geographic diversity of the pandemic require more than one effective vaccine approach,” and that unprecedented collaboration among industry, government, and academia will be essential to meet this need. The authors were encouraged that several different vaccine platforms are moving toward clinical evaluation, citing their different characteristics, such as safety, manufacturing flexibility, and cold chain requirements, that could make them suitable for meeting global needs. They cited the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership as allowing for discussions and consensus on clinical trial design, data sharing, and close public-private collaboration. The authors emphasized that “the ability to manufacture hundreds of millions to billions of doses of vaccine requires the vaccine-manufacturing capacity of the entire world” and that “there is an immediate need to fund the necessary biomanufacturing infrastructure, including the fill/finish steps that provide vialed vaccine products for distribution.”At least 16,000 people, mostly young adults, have signed onto a registry saying they would be willing to be infected with COVID-19 in clinical trials to help accelerate vaccine development. Typically, bioethicists consider it unethical to do human-challenge studies with deadly pathogens that have no approved treatment or cure because of safety risks to patients. The conventional method is vaccinating volunteers during ongoing outbreaks and tracking them for months to monitor infection rates. If human-challenge trials could happen for COVID-19, it could potentially accelerate vaccine development by several months. Researchers note, however, that launching human challenge trials take several months, and that planning should begin now if that’s a route scientists are willing to consider. Requests for human challenge studies must be approved by national regulatory and/or scientific agencies, and not all requests are granted.The Coalition for Epidemic Preparedness Innovations (CEPI), in its single largest investment to date, is providing US$384 million to advance Novavax’s NVX-CoV2373 SARS-CoV-2 vaccine candidate. Novavax will use the funding to further clinical development and expand large-scale manufacturing capacity for the candidate in multiple countries. Novavax plans to be capable of producing 100 million doses by the end of 2020 and potentially 1 billion by the end of 2021.