Breakthroughs Blog

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 Medicines Patent Pool (MPP) has signed agreements with 27 generic manufacturing companies to produce and supply the oral COVID-19 antiviral molnupiravir for 105 low- and middle-income countries. The sublicense agreements follow a voluntary licensing agreement signed by MPP and Merck, Sharp & Dohme—which developed the drug—in October to facilitate global access of the COVID-19 treatment. The nonexclusive licenses allow generic manufacturers to produce the raw ingredients and finished drug itself: five companies will focus on producing the raw ingredients, thirteen companies will produce both raw ingredients and the finished drug, and nine companies will produce only the finished drug. Molnupiravir has not yet been approved by the World Health Organization (WHO), a step often regarded as a precursor to the negotiation of manufacturing licenses by a United Nations-supported group like MPP.Antimicrobial resistance (AMR) poses a significant threat to humanity, as it has become a leading cause of death worldwide killing about 3,500 people every day, according to a new study published in The Lancet last week. More than 1.2 million people—and potentially millions more—died in 2019 as a direct result of antibiotic-resistant bacterial infections. The analysis, which covered more than 200 countries and territories, is the most comprehensive estimate to date of the global impact of AMR, which has caused common infections to become untreatable. The report highlights an urgent need to scale up action to combat AMR and outlines immediate actions policymakers can take to help save lives and protect health systems, including optimizing the use of existing antibiotics, taking greater action to monitor and control infections, and providing more funding to develop new antibiotics and treatments.The COVAX vaccine-sharing facility has delivered 1 billion COVID-19 vaccine doses, across 144 countries, as of last weekend. The program, which was initiated in 2020 with the goal of delivering 2 billion doses by the end of 2021, began delivering vaccines in February 2021 but hit several setbacks throughout the year, including vaccine hoarding by high-income countries and export restrictions which limited vaccine supply. Shipments increased exponentially in the last quarter of 2021, but vaccine inequity remains high, according to the latest WHO data showing 67 percent of the population in richer nations have been fully vaccinated, compared with only 5 percent in poorer nations. More than 40 percent of the world's population has yet to receive a first dose. Gavi, the Vaccine Alliance, has launched a renewed call for COVAX funding to help reach WHO's goal of vaccinating 70 percent of the populations in poorer countries by July.

Many experts have speculated that 2022 could bring the end of this acute stage of the COVID-19 pandemic. But if this proves true, what our new normal will be, and whether we’ll be better prepared for future crises, will depend on the decisions that our policymakers make in the months ahead. As 2022 begins, here are some of the top policy issues GHTC will be tracking.1. Will we achieve targets to vaccinate the world and what curveballs will COVID-19 still throw our way?What trajectory the pandemic will take in 2022 will depend in significant part on how successful efforts are to vaccinate the world. Last year, world leaders coalesced around a goal of vaccinating at least 70 percent of the world’s population by mid-2022, with an interim goal of vaccinating at least 40 percent of people in each country by the end of 2021. But a number of cascading challenges—from unexpected manufacturing disruptions with key suppliers to surging demand for booster shots in wealthy nations—slowed global efforts. As the year drew to a close, more than 90 countries missed the interim target, with many of the poorest nations in sub-Saharan Africa stuck at single digit vaccination rates. In a glimmer of positive news, the COVAX global vaccine facility delivered a record number of vaccine doses in December, hopefully setting a positive trend for the months ahead. Yet it remains clear there is much lost ground to make up as the year kicks off. Reaching the 70 percent target will require a significant influx of resources to boost manufacturing and overcome on-the-ground delivery and administration challenges, as well as continue research to respond to variants and deliver second generation vaccines better suited for distribution in low-resource settings. While leaders of the world’s richest nations have pledged their support for this global goal, few additional commitments of resources have materialized and nearly three-quarters of promised dose donations have yet to be shipped as of December. GHTC will be watching closely in 2022—particularly as President Joe Biden is expected to host a follow-up COVID-19 summit in March—to see whether the world embraces new urgency and accountability to close these gaps. As we’ve seen with the delta and omicron variants, COVID-19 could also still throw some unexpected curveballs our way that could upend existing efforts. 2. Will reams of recommendations turn into meaningful multilateral reforms?One might call 2021 the year of recommendations as several eminent groups, including the Global Preparedness Monitoring Board, the Independent Panel for Pandemic Preparedness and Response, and the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, issued reports recommending actions to reduce the world’s vulnerability to pandemic threats. This included several significant proposed reforms to the existing multilateral architecture, including establishing a new Global Health Threats Council to elevate preparedness to the highest level of political leadership, creating a new financial intermediary fund or financing facility at the World Bank to support countries in strengthening their preparedness capacity and to finance surge response during a crisis, making permanent a structure like the Access to COVID-19 Tools Accelerator (ACT-A) to support end-to-end product development for epidemic threats, and advancing a pandemic treaty or framework convention on health preparedness to reform or build upon existing International Health Regulations. Now it remains to be seen whether 2022 will turn into a year of action to make these reforms a reality. GHTC has long advocated that research and development (R&D) is an essential pillar of health preparedness. As these discussions advance, we will be monitoring closely to see how ACT-A evolves and pushing for any such international agreement or financial fund to support countries in strengthening their research and manufacturing capacity.3. Will the US COVID-19 spending spigot still flow in 2022?During the first year of the pandemic, policymakers in Congress seemed willing to throw unlimited money at the problem, passing a series of huge emergency spending bills to finance response efforts and cushion the pandemic’s reverberating economic impacts in the United States—though money for the international response was slower to arrive and lower than advocates and experts recommended. Now that we’re nearly two years into this crisis, many are asking whether Congress has hit pandemic spending fatigue or whether the spigot will still flow. The last major emergency supplemental funding package—the American Rescue Plan Act (ARPA)—was signed in March 2021, more than ten months ago. But the need for additional resources seems as acute as ever as 2022 begins. On the domestic front, omicron is overwhelming US hospital systems and fueling increased demand for tests and boosters, while on the global front, reports are the US Agency for International Development (USAID) is fast running out of resources, as it has already spent or earmarked most of the money it received through ARPA to support global vaccination and response efforts—just as a significant influx of vaccine doses are finally arriving in partner countries and the international response is entering its most operationally intensive phase yet.Political observers are now watching closely whether Congress will put together a new emergency funding package, possibly pairing it with the regular fiscal year (FY) 2022 spending bills that it must pass before the continuing resolution now funding the government expires on February 18. As these talks advance, global health advocates are pushing for any such package to include substantial resources to replenish the coffers of USAID, the State Department, and the Centers for Disease Control and Prevention (CDC) to lead the international response.4. How exactly will the United States build back better for global health innovation?While congressional policymakers spent 2021 largely in emergency response mode, as the new year begins, many are looking to the future of how we can strengthen US agency programs for health preparedness, as well as build upon the research successes and gaps illuminated by COVID-19. Several pieces of legislation are expected to advance this year, which could significantly transform our health innovation infrastructure.For example, the Senate Health, Education, Labor and Pensions Committee is formulating a new pandemic preparedness bill that will look at retooling and refining the capabilities of several Health and Human Services agencies, potentially including the Biomedical Advanced Research and Development Authority (BARDA). This federal agency, which is responsible for developing medical countermeasures against health threats, went from obscurity to a household name during the pandemic as it was entrusted with an influx of emergency funding more than 40 times its annual appropriated levels to advance COVID-19 vaccines, treatments, and tests. GHTC has long advocated for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza. Much of the agency’s work on EIDs has been funded via unsustainable “boom and bust” cycles of emergency funding appropriated only after a crisis has begun. This pandemic preparedness legislation opens fresh opportunity for Congress to authorize such a permanent funding line to fuel sustainable, proactive preparedness research.Additionally, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) are advancing bipartisan legislation dubbed Cures 2.0, a follow-up to their 2016 21st Century Cures Act, which among other things would authorize a new Advanced Research Projects Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Projects Agency, this new federal agency would seek to speed the development of medical innovations by funding high-risk, high-reward projects not likely to be advanced by traditional commercial research activities. Given this goal, the agency’s work could encompass research on poverty-related and neglected diseases, a recognized area of market failure. But at the moment, ARPA-H is more of rough concept than a fleshed-out proposal. As Cures 2.0 advances, much will need to be worked out as to what the agency’s research scope will actually include; whether it will be housed within the National Institutes of Health as President Biden has proposed or as a separate entity as some stakeholders have advocated for; and how much money congressional appropriators will be willing to pony up for this new unproven agency.Alongside these legislative efforts, GHTC has also recently unveiled a proposal for the creation of a new catalytic fund at USAID to drive global health innovation, called the Supporting Innovative Global Health Technologies (SIGHT) Fund. Such a fund would allow USAID to supercharge its existing work to advance inclusive innovations for low-resource settings, as well as reverse a declining trend in the agency’s spending on R&D as a proportion of its global health budget. As the year continues, GHTC will seek to advance this proposal with policymakers in Congress and the agency.5. Will calls to decolonize global health be codified into policy and practice?Calls to decolonize global health gained steam last year as the world bore witness to the gross inequities in access to COVID-19 vaccines and other tools between rich and poor nations, and here in the United States, the Black Lives Matter movement forced Americans to reckon with our nation’s history of racism past and present. While many leaders in the global health and development field now recognize the need to correct long-standing power imbalances rooted in the colonial era, individual organizations—from nongovernmental organizations to international institutions to development agencies—are grappling with how to translate this goal into policy and practice. Here in the United States, new USAID Administrator Samantha Power, in one of her first public addresses in November, laid out her vision for a new era of “inclusive development” at USAID. This included targets to direct at least a quarter of USAID funding to local partners within the next four years and by the end of the decade to have 50 percent of USAID programming have in place “local communities in the lead” who are responsible for codesigning, implementing, and evaluating programs. As 2022 continues, the global health community will be watching closely how Administrator Power’s vision leads to concrete changes in programs and practices at the agency.6. Will funding for other global health areas grow to match evolving needs?Much has been documented about how the COVID-19 pandemic has set back progress in other areas of global health, from disrupting routine immunization programs and reliable access to HIV and tuberculosis drugs to increasing the cost and complications of conducting research and clinical trials. The common refrain from health practitioners is that more resources are needed not just to respond directly to COVID-19, but to shore up other vital global health programs to protect fragile progress. Here in the United States, we’ll be watching whether congressional appropriators take this need to heart in 2022 as they finalize FY 2022 spending bills and begin work on FY 2023. Outside of programs focused on health security, most global health-related funding lines at the CDC, State Department, and USAID have been flat-funded in recent years, in practice decreasing their purchasing power as COVID-19 has only increased the cost of doing business. As every country worldwide is feeling the weight of the latest omicron-fueled surge, the first few days of 2022 have unfortunately felt much like “2020, two.” But as the year continues, it is our hope the pandemic will turn a corner and that policymakers will embrace lessons learned from this crisis to ultimately usher in a healthier, safer, and more equitable world for all.

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.A World Health Organization (WHO) panel on Thursday recommended the use of two additional drugs, baricitinib and sotrovimab, for COVID-19 patients. Baricitinib, developed by Eli Lilly and sold under the brand name Olumiant, was recommended in combination with corticosteroids for patients with severe COVID-19. WHO experts cited evidence indicating that baricitinib—an oral drug also used to treat rheumatoid arthritis—improves survival rate and reduces the need for ventilation, with no observed increase in adverse effects. Sotrovimab, a monoclonal antibody therapy developed by GlaxoSmithKline (GSK) and Vir Biotechnology, was conditionally endorsed for non-severe patients at the highest risk of hospitalization. Studies on the effectiveness of monoclonal antibodies against the omicron variant are ongoing, though the GSK-Vir treatment has been shown to retain its activity in initial lab tests.An mRNA-based HIV vaccine candidate developed at the National Institute of Allergy and Infectious Diseases (NIAID) showed promise in preclinical studies, new research shows. The experimental vaccine works by delivering instructions for making two key HIV proteins, which are then assembled into virus-like particles that induce immune responses similar to natural HIV infection. NIAID tested the vaccine in mice and rhesus macaques, results of which showed the injections were well-tolerated and elicited immune responses against an HIV-like virus. The research team plans to conduct a phase 1 trial of the novel mRNA HIV vaccine in healthy adult volunteers after further refinement and testing.Researchers at UCLA have made progress in efforts to develop a cure for HIV by targeting infected cells that could be lying dormant in the body, according to a study published in Nature Communications last week. In the new study, researchers built upon a method originally developed in 2017 to kill hidden HIV-infected cells using cells that are naturally produced by the body’s immune system. The study used the “kick and kill” strategy, with researchers first administering a compound to flush out hidden HIV-infected cells, then injecting natural killer cells into a mice’s bloodstream. This cleared HIV completely in 40 percent of infected mice, showing proof of concept for a therapeutic approach to potentially eliminate HIV from the body. Researchers say they now hope to develop an approach that eliminates HIV in 100 percent of tested mice via further experiments and move toward preclinical studies.

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.Novavax has completed submission of the final data package for its COVID-19 vaccine to fulfill the prerequisites for an emergency use authorization (EUA) request from the US Food and Drug Administration. The company plans to complete an official EUA application by the end of the month. The vaccine, NVX-CoV2373, received emergency use listing from the World Health Organization last month for its formulations manufactured in Europe and India, allowing Novavax and partner Serum Institute of India to ship doses to the COVAX initiative, which aims to supply vaccines to low- and middle-income countries. NVX-CoV2373 was also granted conditional marketing authorization in December by the European Medicines Agency to be produced in Europe. Novavax expects its global supply chain to exceed 2 billion doses in 2022.A new COVID-19 vaccine developed by researchers from the Texas Children’s Hospital and Baylor College of Medicine is being offered patent-free to vaccine manufacturers around the world. The CORBEVAX vaccine—originally developed to combat SARS, which is caused by a strain of coronavirus—employs a long-established protein subunit technology that uses proteins from a virus or bacterium to induce an immune response but not cause disease. Clinical trials conducted in India found the vaccine to be 90 percent effective in preventing disease caused by the original COVID-19 virus strain and 80 percent effective against the delta variant, leading India’s regulatory agency to grant emergency use authorization in December. Indian vaccine manufacturer Biological E Limited has sold 300 million doses to the Indian government and plans to produce 100 million doses per month.Dolutegravir-based antiretroviral therapy (ART) is more effective than standard treatments for HIV-positive children, reducing treatment failure by 40 percent, according to a new study published in The New England Journal of Medicine. The clinical trial, conducted at 29 clinical centers across Africa, Europe, and Asia, evaluated the safety and efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV in comparison to non-dolutegravir-based, standard-care ART. Results showed the dolutegravir-based ART reduced treatment failure by 40 percent in HIV-positive children 3 to 18 years old, indicating dolutegravir-based ART is superior to current standard-care treatment in children and adolescents living with HIV, according to researchers.