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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. Last week, UNICEF signed an agreement with Human Vaccine, a subsidiary of the Russian Direct Investment Fund, for supply of up to 220 million doses of the Sputnik V COVID-19 vaccine. Procurement of the doses will be contingent on the vaccine receiving emergency use listing from the World Health Organization (WHO) and an advance purchase agreement with Gavi, the Vaccine Alliance, for the COVAX vaccine-sharing facility. The organizations leading COVAX also made an announcement last week renewing the call for funding and vaccine sharing, urging countries to share at least 1 billion doses in 2021. COVAX has so far delivered more than 70 million doses to 126 countries and economies since February, but it will face a shortfall of 190 million doses by the end of June, according to the statement.The US Food and Drug Administration on Wednesday authorized a new monoclonal antibody therapy for patients ages 12 and older with mild-to-moderate COVID-19 who are at high risk for infection. Sotrovimab, developed by GlaxoSmithKline (GSK) and Vir Biotechnology, reduced risk of hospitalization or death due to COVID-19 by 85 percent in a study of 583 volunteers who had begun experiencing symptoms within the previous five days. It was also shown in laboratory tests to be able to neutralize the virus variants first identified in the United Kingdom, South Africa, Brazil, California, New York, and India. The US government has not announced plans to purchase the drug, but the companies expect the drug to become available in the United States in the coming weeks, according to the GSK news release.Two COVID-19 vaccines made by Sinopharm appear safe and effective, according to results published in the Journal of the American Medical Association. The report indicated that the two vaccines, one developed by the Wuhan Institute of Biological Products and the other by the Beijing Institute of Biological Products, are 73 and 78 percent effective, based on a trial involving approximately 40,380 participants. Follow-up data is continuing to be collected at additional study sites in Egypt and Jordan. The numbers are consistent with results Sinopharm had previously reported in interim analyses. WHO cleared the Beijing Institute of Biological Products’ vaccine for emergency use in early May, and both vaccines have already been distributed and administered globally.

The following statement—from Global Health Council, supported by the Global Health Technologies Coalition, Management Sciences for Health, and Partners in Health—was submitted to the 74th World  Health Assembly on agenda items 13.4: Global strategy and plan of action on public health, innovation and intellectual property; 13.6: Substandard and falsified medical products; and 13.7: Standardization of medical devices nomenclature.Global Health Council in collaboration with GHTC, PIH, and MSH would like to provide the following feedback on these agenda items.As outlined in the WHO review panel’s report, although progress has been made in certain aspects of both innovation and access, many of the challenges that motivated formulation of the GSPOA remain, and the COVID-19 pandemic has exposed both long-standing shortcomings as well as new challenges. These include a lack of new health products in areas of need, the unaffordability of many new medicines and other health technologies, ineffective delivery and supply chain infrastructure, and the absence of robust regulatory systems, primarily but not exclusively in low-income countries.To address these challenges and ensure faster access for patients to safe and effective products, we urge the WHO and Member States to strengthen the capacity of national and regional regulatory functions and systems, including improving late-stage clinical trial regulatory review and oversight. We also call on Member States to support the resolution being advanced to strengthen the local production of medicines and health technologies. This requires transparency; all data associated with publicly funded R&D should be made publicly available. We urge Member States to also ensure better regional collaboration for regulatory functions and manufacturing. The COVID-19 pandemic has underscored the risk of overreliance on international health supply chains, imported medicines and other health technologies and donor support. The current draft resolution being co-sponsored by multiple African countries calls for Member States to support regulatory systems strengthening, access to sustainable and affordable financing, and development of skilled human resources. We urge the WHO, member states, and partners to promote sustainable local production to improve access to quality, safe, effective and affordable medicines and other health technologies.