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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. On Friday, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.The US National Institutes of Health (NIH) is sponsoring two phase 3 clinical trials investigating monoclonal antibodies as treatment for hospitalized COVID-19 patients with moderate illness. The trials are sub-studies of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program, an adaptive trial designed to investigate new therapeutics as they become available. One of the treatments, developed by GlaxoSmithKline and Vir Biotechnology, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody with potential to neutralize the virus and kill infected cells. The second treatment, developed by Brii Biosciences, is a combination of two neutralizing monoclonal antibodies. Both trials hope to show treatment efficacy in hospitalized patients, a subset of patients for which monoclonal antibody treatments have so far not shown an impact.The FDA granted EUA last week to the first-of-its-kind rapid COVID-19 test that can be conducted fully at home without need for a prescription. The diagnostic, which was developed by Ellume, detects SARS-CoV-2 virus fragments from a nasal swab sample using an analyzer that connects with a smartphone app, providing results in as little as 20 minutes. While less accurate than typical molecular diagnostics, the test has shown a sensitivity of 96 percent and specificity of 100 percent and, in asymptomatic individuals, a sensitivity of 91 percent and specificity of 96 percent. Ellume intends to produce around 3 million tests by next month and 20 million by the second half of 2021 to be accessible in drug stores for over-the-counter use.

The Global Health Technologies Coalition (GHTC) urges Congress to pass a COVID-19 emergency supplemental bill that includes at least $11 billion for global health programs to support the international response to this unprecedented global health emergency. As the death toll of this pandemic crosses a grim threshold of more than 1.6 million lives lost worldwide, global solidarity and cooperation to defeat COVID-19 are essential. However, GHTC notes that international funding has not been included in any of the bill proposals released in the past month. If not corrected in the final bill taken up by Congress this week, this grave oversight will have profound long-term implications for health and economic recovery globally and here in the United States.While the global burden and death toll of COVID-19 is staggering, the full impact of the pandemic is coming into clearer view, and the case for US leadership of a coordinated global response has never been stronger. Recent analyses have raised the volume of alarm bells global health advocates have been ringing for months: UNICEF estimates that an additional 1.2 million children will die of preventable causes other than COVID-19 due to pandemic-related disruptions to health care. The Global Fund estimates that an additional 1 million people could die of AIDS and tuberculosis in 2021. The World Bank estimates that an additional 150 million people will fall into extreme poverty by the end of next year. Fortunately, these stunning numbers are warnings, not pronouncements: the United States, beginning with the COVID-19 relief bill before Congress this week, can and should take decisive action to reverse these trends and accelerate global recovery by investing in proven partners, programs, and systems that can save lives and prevent economic catastrophe in the most vulnerable regions of the world.GHTC echoes the core message endorsed by our coalition and more than 50 other partner organizations in a September message to congressional leadership: “Reducing human suffering and helping people around the world is a cornerstone of U.S. foreign policy…The U.S. led the establishment of the Global Health Security Agenda, developed life-saving vaccines for Ebola and Zika, trained disease detectives in countries around the globe to detect outbreaks and deploy a rapid response, and has made countless other contributions to strengthening global health security. By mounting Grand Challenges for Ebola, Zika, and Saving Lives at Birth, we have ensured that American innovation is put to use to solve global challenges. Now is the moment to ensure that these resources can be brought to bear for the global response to COVID-19 through the allocation of emergency funding—at a price tag that is modest in comparison to the cumulative investment in global health. The global effort to end the COVID-19 pandemic will be a long road, but an investment in the global response now is a down-payment on maintaining American progress against the pandemic.” Our appeal has remained the same for months: in the next COVID-19 relief bill, Congress should appropriate at least $20 billion in emergency funding for programs funded through the International Affairs Budget, including at least $11 billion for bilateral global health programs and the multilateral response to support a holistic global response to COVID-19. GHTC particularly underscores the need for dedicated funding for the US Agency for International Development’s (USAID) Global Health Bureau to support the development and deployment of COVID-19 products designed for use in low-resource health systems—a prerequisite to ending this pandemic globally and keeping Americans safe. USAID partners stand ready to adapt and deploy game-changing technologies to fight COVID-19 if sufficient funding is allocated. The agency’s deep international footprint, combined with its in-depth understanding of community needs, enables the agency to develop new health tools that are appropriate, affordable, and accessible for widespread use in low-resource settings where basic resources like electricity and clean water may be in short supply—including during health emergencies. In previous global health crises such as the West African Ebola epidemic and the Zika epidemic in Latin America, USAID helped crowdsource and advance to market innovative technologies to fight these outbreaks, and it is poised to do so again in the face of COVID-19—with adequate resources. In March, USAID issued a request for information seeking proposals for low-cost, scalable innovations that could support the international COVID-19 response, including new products, service delivery approaches, and information channels. The agency has received hundreds of proposals for potentially game-changing innovations, but funding is urgently needed to advance and scale them. As discussed during a November roundtable with innovators and congressional staff, many of these innovations could support the COVID-19 response in low-resource and rural communities right here in the United States as well as globally—with forward-thinking congressional investment in USAID’s unique capabilities.Furthermore, Congress should support a robust US contribution to the Coalition for Epidemic Preparedness Innovations (CEPI) to advance COVID-19 vaccine candidates. Support for CEPI will help ensure that vaccines developed will be deployed effectively worldwide to help those most in need. Supporting such bilateral and multilateral investments in the global response will ultimately benefit the United States: a recent analysis suggests that the United States has more to gain from contributing to international efforts to secure access to COVID-19 tools than any other donor country, with $78.8 billion in economic benefits at risk in 2020-21 and $207.1 billion at risk from 2020-25 if action is not taken now.GHTC urges leaders in Congress—who have for two decades championed transformative investments in strengthening global health—to not let the tremendous challenges faced by our country this year obscure our vision for what American global leadership can accomplish. As the first COVID-19 vaccines are delivered to health workers across our country, we are reminded of the power of science, innovation, and partnership to solve challenges that once appeared insurmountable. At this moment of global crisis, we must draw on the strengths of all partners to ensure that together, we can end the COVID-19 pandemic. An investment of at least $11 billion to support global health programs now will be remembered by our allies and partners for decades to come as we look back on the first year of the greatest global health challenge in a century: we urge Congress not to let 2020 end without this demonstration of global solidarity.

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 US Food and Drug Administration (FDA) on Friday granted emergency use authorization (EUA) to Pfizer and BioNTech’s COVID-19 vaccine candidate, following a vote by the agency’s independent advisory panel last Thursday recommending authorization. Results from the vaccine’s phase 3 clinical trial released in late November showed 95 percent efficacy of the two-dose regimen, leading the companies to submit the candidate to regulatory bodies around the world. The candidate, the first mRNA-based vaccine ever to receive regulatory authorization, is the first COVID-19 vaccine to receive a green light in the United States and has also been authorized in the United Kingdom, Canada, and several other countries. The EUA allows the United States to begin vaccinating people 16 years of age and older in a massive distribution effort prioritizing health care personnel and residents and staff of long-term care facilities.As COVID-19 vaccine approval and rollout becomes a reality, a group of global health organizations is warning that low-income countries will face extreme challenges with vaccine access due to high-income countries securing a vast majority of the global vaccine supply through advance purchase deals with vaccine developers. Data on these agreements and the current vaccine pipeline indicates that nearly 70 low- and middle-income countries will be only able to vaccinate 10 percent of their populations against COVID-19 in the next year. A recent study also outlines the confirmed purchases of at least 6.8 billion doses by primarily high-income countries, creating a risk that lower-income countries will be forced to wait for doses, deepening existing inequities and furthering economic damages. Low-income countries will likely be reliant on doses provided through the COVAX Facility, a global mechanism to speed up development, manufacturing, and equitable distribution of COVID-19 vaccines—an initiative researchers say is being undermined by these unequal vaccine deals.Efforts to develop COVID-19 treatments are moving forward as companies look to add to the arsenal of therapeutics helping to minimize the effects of COVID-19 illness. Since the onset of the pandemic, FDA has authorized a few treatment options, including remdesivir, convalescent plasma, and monoclonal antibodies. Other therapeutics remain under development, including an apelin agonist peptide treatment developed by CohBar, which recently demonstrated efficacy in preclinical models to treat acute respiratory distress, and Sorrento Therapeutics’ intravenous STI-2020, which recently received FDA clearance to begin phase 1 trials as a potential early treatment for COVID-19 outpatients with mild symptoms. Both developers plan to accumulate further safety and efficacy data of the therapeutics in the upcoming months.