Breakthroughs Blog: COVID-19

Editor’s update, June 17, 2021: At the G7 summit, member countries committed to sharing at least 870 million COVID-19 vaccine doses over the next year. While this pledge is welcome, it falls short of the 1 billion target touted in the lead-up to the summit and only a small fraction of the 11 billion doses still needed to vaccinate 70 percent of the global population. Additionally, no new financial commitments were made to the Access to COVID-19 Tools Accelerator, which is facing a US$18.1 billion funding gap. In a positive directional step, leaders promised to “explore options for building consensus this year, around sustainable global health and health security financing,” and affirmed that they “support efforts to accelerate manufacturing capacities of COVID-19 tools on all continents…and in particular will strive to support African efforts to establish regional manufacturing hubs.” However, there was no clear guidance on how the G7 will transform these high-level pledges into concrete action. Overall, member states affirmed the sustained importance of research and development for COVID-19, promising “to continue our investment in cutting edge research and innovation,” expand genomic sequencing and sharing, and build upon existing innovation and collaboration.This weekend, leaders from the G7 will come together in Cornwall, England, for the first in-person summit of this group in two years, after last year’s meeting was cancelled and high-profile geopolitical rows caused much acrimony at previous convenings. Leaders are seeking to revive multilateralism and highlight that this forum can still play a significant role in shaping and responding to major world events. Their most urgent task will be to tackle the global pandemic and particularly address the unequal distribution of COVID-19 tools, as well as start to build additional long-term infrastructure and capacities both regionally and globally to prevent future health outbreaks. Greater coordination around innovation and greater investment in research and development (R&D) capacities as part of health system strengthening and pandemic preparedness should play a crucial role in these discussions, and G7 leaders must seize the moment to take bold action and reimagine the future of global health security.G7 leaders take first steps to create improvements to the global health security architectureLast week, health ministers already took several steps toward scientific collaboration to address current and future health threats by making concrete pledges in their G7 Health Ministers’ Declaration. This included adopting a new therapeutics and vaccines clinical trials charter, which sets out shared principles to accelerate the speed with which clinical trials generate robust evidence and lead to quicker adoption of new tools in this and future pandemics. This charter will strengthen collaboration in large-scale international trials and enable greater diversity of participants, including pregnant people and children.Health ministers also agreed to develop a shared set of principles that could incentivize the development of and access to both novel and existing antimicrobial products and ensure a sustainable antimicrobial R&D ecosystem, including resilient and diverse supply chains and greater manufacturing capacity. They also underscored the important contributions of several initiatives and organizations, including the Global Antibiotic Research and Development Partnership as well as Global AMR R&D Hub, which push for accelerating the development of novel technologies to fight antimicrobial resistance.Scientific capabilities, including pathogen genomics, also have a vital part to play in surveillance and development of new tools, and leaders also sought to create platforms to enable greater collaboration through the United Kingdom’s New Variant Assessment Platform, as part of a focused global effort to strengthen surveillance of potential COVID-19 variants of concern and potential future priority pathogens.While these decisions represent progress and are welcome steps in the right direction, with the pandemic still raging in much of the world, both immediate COVID-19 needs and larger reform efforts will have to be addressed simultaneously during the Leaders’ Summit.The time for bold action is nowGlobal leaders must take immediate decisive action to fully fund the Access to COVID-19 Tools Accelerator (ACT-A) and fill urgent gaps for all aspects of the current global framework, including the diagnostics and therapeutics pillars. This means G7 leaders should pledge 60 percent of the US$19 billion required for ACT-A in 2021 during this weekend’s summit. This would ensure that organizations like the Coalition for Epidemic Preparedness Innovations are properly resourced to advance R&D, ensuring that vaccines are keeping up with variants and that diagnostics and other medical countermeasures are not neglected as part of the global response efforts.Testing, oxygen therapies, and therapeutics are central to combatting the pandemic and must be recognized through continued investment. This is especially relevant given that fewer than one in five health facilities across Africa had access to COVID-19 tests in 2020. To address these imbalances, further innovation is needed to ensure appropriate, high-quality rapid tests and other health tools are affordable and available everywhere. Donor countries must scale up the production of tests, treatments, and health commodities, including oxygen, and accelerate low- and middle-income country (LMIC)-led R&D to ensure greater equitable access globally.Many advocates are also expecting G7 leaders to finally deliver on vaccine sharing, release more vaccine doses to COVAX, and commit to a clear strategy for global vaccination. While the politics of prioritizing their own domestic populations represents a continuing factor for global leaders, especially with G7 countries not having reached herd immunity at home, there are clear epidemiological and ethical imperatives to accelerate the pace of vaccine shipments abroad. The Biden administration did take a major first step with the announcement that the US government will purchase 500 million doses for LMICs, with 200 million doses being shared by the end of this year. Now other donor nations must follow suit and raise their ambition at this forum and scale up their own dose sharing pledges and allocation strategies. G7 leaders should pledge 2 billion doses at the Leaders’ Summit, delivering 1 billion by the end of August and the second billion by the end of 2021, and as part of this delivery, ensure that 250 million additional people in LMICs have actually received their doses by the end of August in parallel with national vaccine rollout plans.Laying the groundwork for future pandemic response frameworksWe have seen during this pandemic how essential scientific collaboration has been, and how investment in R&D spurred unprecedented innovation of new vaccines and other health technologies in record time. These successes continue to be hampered by a lack of equitable access, unpredictable and insufficient funding, and a lack of clear coordination frameworks. G7 leaders have an opportunity this weekend to also start to outline a road map for the future and make concrete commitments to reform efforts for the pandemic preparedness ecosystem. This includes leveraging existing multilateral institution resources in new ways, unlocking sustainable financing for global health innovation by making R&D investments eligible for financing from the World Bank and other international financial institutions, and creating new financial mechanisms for pandemic preparedness. This new capital would support LMICs in securing new resources to strengthen their research, laboratory, surveillance, and manufacturing capabilities, and ensure that all countries have pathways to gain access to the innovations and health technologies they need to respond to health outbreaks.The pandemic has elevated and highlighted the importance of science, the power of partnerships, and the necessity of investing in R&D to ensure that countries are equipped with the vital tools to respond to major health outbreaks. G7 leaders must now ensure that the pressing challenge of global equity is addressed and use the political momentum to create the kind of game-changing reforms that enshrine greater scientific coordination and clear preparedness structures that allow for a more equitable and comprehensive global response to future health threats. This summit is a test for G7 leaders, especially for the United Kingdom as host, as the group must come together to ensure that any new commitments to strengthening the health security architecture do not come at the expense of decades of investments in other health R&D areas.

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. An experimental oral antiviral drug showed promise as a potential treatment for COVID-19 after demonstrating an ability to prevent the virus from replicating, according to study results from the National Institutes of Health (NIH). The drug, TEMPOL, was tested in an experiment of cell cultures with live viruses and was able to impair an enzyme the virus needs to make copies of itself inside human cells, which could limit the severity of the disease. An oral drug to prevent virus replication would be an important tool, as additional effective and accessible COVID-19 treatments are still needed, according to the NIH statement. NIH researchers said they plan to conduct additional preliminary studies and will seek opportunities to evaluate the drug in a clinical study.The World Health Organization (WHO) approved the Sinovac-CoronaVac COVID-19 vaccine for emergency use on Tuesday after evaluating its safety, efficacy, and quality. Other COVID-19 vaccines that have been authorized by WHO include those developed by Sinopharm, Pfizer, Moderna, Johnson & Johnson, and AstraZeneca. The emergency use paves the way for countries around the world to approve and import the vaccine for distribution quickly, according to the WHO press release, in addition to being a prerequisite for use by the COVAX global vaccine-sharing facility. WHO also noted that the easy storage requirements of the vaccine make it suitable for use in low-resource settings.The COVAX advance market commitment (AMC) initiative raised US$2.4 billion to fund COVID-19 vaccines for low- and middle-income countries, in addition to 54 million vaccine donations, during a COVAX AMC virtual summit on Wednesday. This brings the total pledged to the COVAX AMC to $9.6 billion. The summit, hosted by the government of Japan and Gavi, the Vaccine Alliance, brought in donations from nearly 40 governments, the private sector, and foundations that will be used to secure 1.8 billion doses of COVID-19 vaccines for AMC-participating countries. The vaccines will be delivered in 2021 and early 2022 and will cover close to 30 percent of the adult population against COVID-19 in the 91 participating countries. 

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.

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. On Wednesday, the US Food and Drug Administration (FDA) announced the Pfizer/BioNTech COVID-19 vaccine can be safely stored at refrigerator temperatures for up to a month, an expansion from the previous five-day limit. The authorization followed Pfizer’s submission of data to the agency supporting extended refrigerator storage of undiluted, thawed vials. The European Medicines Agency also authorized the change last week. The relaxed storage requirement should lead to more widespread availability of the vaccine by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store, and administer the vaccine, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. The Sanofi/GlaxoSmithKline (GSK) COVID-19 vaccine candidate generated strong levels of neutralizing antibodies in recipients across all ages studied, according to phase 2 trial results announced by the companies last week. No safety or tolerability concerns arose in the trial. The two-dose vaccine is a recombinant protein vaccine and does not require an elaborate cold chain for storage and distribution. Sanofi and GSK also noted that high neutralizing antibody levels were generated after a single dose in participants with evidence of prior SARS-CoV-2 infection, which could suggest its value also as a booster used after an initial vaccination series. A large, international phase 3 trial is set to begin in the coming weeks, and the companies also plan to conduct studies targeting various variants of concern.The United States committed to sending an additional 20 million COVID-19 vaccine doses to other countries last week, following an initial announcement that it would share 60 million doses of the AstraZeneca vaccine, which has not yet been authorized by the FDA. In Monday’s announcement, the Biden administration committed to sharing surplus supplies of the FDA-authorized Pfizer, Moderna, and Johnson & Johnson vaccines, in addition to the AstraZeneca vaccine doses, for a total of 80 million doses sent overseas in the next six weeks. Currently, only 0.3 percent of all COVID-19 vaccine doses administered worldwide have been given in low-income countries.