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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. 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. 

The Global Health Technologies Coalition issued the following statement in advance of the 73rd World Health Assembly, which will be held virtually May 18–19.The current pandemic is a powerful reminder of our interconnectedness and vulnerabilities and the need for science rather than politics to drive the decision-making. The virus respects no borders. Combating COVID-19 calls for a robust, coordinated, large-scale, and science-based global response. Innovation is our exit strategy to defeating the coronavirus, and billions of dollars of public, philanthropic, and private funding are being poured into research and development (R&D) efforts to detect, treat, and prevent COVID-19. Yet as new initiatives and programs are being set up across the globe, the need for international collaboration and cooperation grows. 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 now more than ever member states need to re-commit to multilateral solutions to solve this crisis.As the world gathers for the first-ever virtual World Health Assembly, member states should seize the moment to enhance international R&D collaboration to collectively contain, mitigate, and defeat the COVID-19 pandemic. This includes supporting the WHO-led Access to COVID-19 Tools (ACT) Accelerator and mobilizing financial resources to support global efforts that accelerate the development of new tools, including through open innovation and technology sharing, to improve access to necessary medical technologies and their distribution.Furthermore, GHTC applauds WHO’s launch of the Solidarity Trial, which is currently being carried out in over 100 countries. By using its reach and convening power, WHO is fast-tracking and scaling up randomized clinical trials around the world and enrolling an unprecedented number of patients. We call on member states to support the Solidarity Trial and participate in this WHO-led global research effort. Member states should also look beyond the current pandemic, and support the broader research needs in lower-and-middle-income countries and financially support these studies.With testing being such a central concern for all countries, GHTC is pleased to see WHO opening the Emergency Use Listing Procedure (EUL) for in vitro diagnostics for COVID-19 and hopes to see this procedure leveraged for therapeutics and vaccines as new products are developed or adapted to quell the pandemic. Many countries have regulatory gaps and lack local laboratory capacity. The EUL helps countries assess and prioritize safe and quality products for their populations and accelerates access to these innovations. While these products are still meant to go through the regular regulatory assessment and WHO prequalification, we call on WHO to further streamline and adapt technology assessment processes to accelerate the uptake of emerging COVID-19 health products. WHO should continue its efforts to help coordinate with national regulatory agencies to allow for speedier approval timelines and harmonize regional and global requirements for emerging tools and technologies to combat the pandemic.Member states should promote both public and private sector­–funded R&D for vaccines, diagnostics, and therapeutics, and inform WHO on these activities. Research in resource-constrained settings must be accelerated and supported to identify the tools and interventions that will save lives. Furthermore, new or adapted products to address COVID-19 must be made equitably available without discrimination of any kind, including country of residence or national origin. This means they need to be available in sufficient supply, offered at an affordable price, and appropriate for geographies with limited resources such as electricity.Finally, the pandemic is having a catastrophic impact on the most vulnerable communities worldwide and threatens progress in the fights against HIV, tuberculosis, malaria, hepatitis, neglected tropical diseases, as well as antimicrobial resistance. As many program activities and capacities are being redeployed to respond to COVID-19, WHO and member states should ensure that key R&D priorities for other diseases are maintained and that funding is not diverted from existing R&D commitments.