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June 28, 2023

GHTC provides recommendations for pandemic accord at HHS listening session

GHTC submitted recommendations to bolster health R&D provisions within the proposed pandemic accord at a US Department of Health and Human Services listening session on the Intergovernmental Negotiating Body’s zero draft.

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GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 28, 2023 on the zero draft of the Intergovernmental Negotiating Body's zero draft of a pandemic accord.The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing Intergovernmental Negotiating Body process and highlight that our focus remains the innovation of and equitable access to health tools, thereby strengthening the world’s capacities for preventing, preparing for, responding to, and recovering from pandemics.We call on the United States to consider explicit language in the draft that highlights the need for interconnectedness between health system strengthening and pandemic preparedness and includes provisions that underscore the need to focus on sustainability and dual use when it comes to research and development. We note that Article 9 currently does not cover incentivizing continuous research to develop vaccines, diagnostics, therapeutics, and other health technologies for diseases that cause outbreaks primarily in lower- and middle-income countries but are not profitable for manufacturers to produce, such as those for cholera, Ebola/Marburg fever, and other neglected tropical diseases. Continuous research can accelerate the development of medical countermeasures for novel pathogens, as was the case when research on an mRNA vaccine for HIV helped to speed up the development of the COVID-19 vaccine. A provision should be added for supporting such research.Article 9 also outlines important principles of an effective and equitable system for developing the research base needed to accelerate the production of pandemic countermeasures; however, the latest draft does not currently include provisions for accountability of these principles. As an example, there should be an explicit reference to the inclusion of underserved populations in all their diversity in clinical trials, including children and people who are pregnant or of child-bearing age. GHTC would also appreciate more clarity on whether the newly proposed medical countermeasures platform could eventually fit into this space.We also urge the United States to support provisions strengthening the capacity of regional regulatory bodies, like the newly formed African Medicines Agency. Investing in the regulatory capacity, and not just harmonization, of these regional bodies will help fill gaps for countries with lower regulatory maturity levels. There is a need to include text that establishes national and regional policies or protocols for the regulation of products during health emergencies. Currently, the draft only highlights general regulatory harmonization and focuses on the licensing of pandemic products without taking into account broader elements of the regulatory ecosystem.

PATH/Minzayar

June 26, 2023

GHTC provides recommendations on IHR amendment process at HHS listening session

GHTC submitted recommendations to strengthen the inclusion of R&D capacity needs within the International Health Regulations (IHR) at a US Department of Health and Human Services (HHS) listening session on the IHR amendment process.

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GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 20, 2023 on the amendment process for the International Health Regulations (IHR).The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing International Health Regulations (IHR) amendment process. GHTC supports the ongoing negotiations of the Working Group on Amendments to the International Health Regulations (WGIHR) as it continues to advance discussions of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies. These negotiations must be inclusive and transparent and must find ways to meaningfully engage a broad spectrum of stakeholders to ensure a successful outcome. We would encourage the United States to use its voice as a member state to ensure that non-state actors can engage in these processes and have the opportunity to provide their technical expertise.We also wish to stress the importance of embedding research as a core pillar of health preparedness and that capacity-building assessments must reflect the essential role that research and development plays in responding to pandemics. While some progress was made in the latest version of the Joint External Evaluation (JEE), including adding a specific indicator to measure research and development with a particular focus on implementation research, the United States should push the World Health Organization (WHO) and other member states to also consider further revisions or expansion of the JEE to better reflect a range of health preparedness requirements, including the ability to develop and manufacture medical countermeasures, as well as regulatory indicators that assess capacity to rapidly approve new health technologies. Meaningful end-to-end development of medical countermeasures only happens when research, manufacturing, and regulatory capacities can come together.The United States must also underscore its commitment to the Global Health Security Agenda (GHSA) and work with partners to ensure that the framework can continue to play an important role in IHR implementation. GHSA has offered a unique and valued platform to drive country ownership, multisectoral cooperation, and innovation for health security, and a new framework that is built with the changing global health architecture in mind, including a stronger focus on research coordination, as well as clinical trial, regulatory, and manufacturing capacities in lower- and middle-income countries, should be a key focus for the working group.While not every country needs a full suite of capabilities for the end-to-end development of vaccines, diagnostics, therapeutics, and other technologies, like personal protective equipment and oxygen therapies, through manufacturing, every country should have a plan and pathway to gain access to these tools at an affordable price when needed.

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October 24, 2022

World Polio Day 2022: As polio cases surge, so does the need to deploy new vaccines

In observance of World Polio Day on October 24, GHTC is reflecting on the biggest news about this year’s polio outbreaks and on the connection between this year’s outbreaks and polio vaccines, as well as the potential of new vaccines to contribute to eradication.

Written by Hannah Sachs-Wetstone / GHTC

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2021 was a year of significant progress in the global effort to eradicate polio, despite challenges due to the COVID-19 pandemic. Unfortunately, as we sit toward the close of 2022, the outlook is less optimistic. Recently, polio has been popping up in the news with increasing frequency as outbreaks have occurred around the world. In observance of World Polio Day on October 24, GHTC is reflecting on the biggest news about this year’s polio outbreaks and on the connection between this year’s outbreaks and polio vaccines, as well as the potential of new vaccines to contribute to eradication. The development of a vaccine against polio was one of the most important and impactful medical technological breakthroughs of the last century and since then, more than 2.5 billion children have been vaccinated through the Global Polio Eradication Initiative, a public-private partnership led by national governments, the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention, UNICEF, the Bill & Melinda Gates Foundation, and Gavi, the vaccine alliance. Two types of vaccines are used for polio. The oral polio vaccine (OPV) is used in mass vaccination campaigns in low- and middle-income countries, while the inactivated polio vaccine, which is more expensive and complex to administer, is used in most high-income countries. One of the largest remaining challenges in global polio eradication efforts is that in rare cases, the use of OPV in areas of low vaccine coverage can lead to vaccine-derived polio, which partly accounts for the recent rise in cases. For a short time after OPV immunization, children have the weakened vaccine-virus in their bodies and excrete it. In areas of low immunization, if the excreted vaccine-virus circulates for an extended period of at least a year, it could change genetically to the circulating vaccine-derived poliovirus.Vaccine-derived polio has emerged due to outbreaks of the type 2 virus, which was removed from the oral vaccine by WHO in 2016 after it was declared to be eradicated. In 2020, in response to vaccine-derived outbreaks, WHO granted an emergency use authorization for a novel oral vaccine that is aimed at type 2 poliovirus (nOPV2) and is less likely to lead to vaccine-derived cases. The first-ever vaccine authorized under WHO’s Emergency Use Listing process, nOPV2 was rolled out in March 2021 and doses of the vaccine have already been delivered in over 20 countries. However, supply constraints and challenges in vaccine uptake need to be addressed for nOPV2 to be rolled out more widely. Full immunization throughout populations would prevent the spread of vaccine-derived polio, highlighting the importance of employing polio vaccines in order to prevent the outbreaks we have seen this year.Read more about this year’s spate of outbreaks:"In new setback for eradication campaign, poliovirus from Pakistan shows up in Africa" (Science, 2/17/2022)"Polio is found in the U.K. for the first time in nearly 40 years. Here's what it means" (NPR, 6/22/2022)"Wastewater monitoring identifies polioviruses in New York City" (STAT, 8/12/2022)"The Guardian view on polio: we have the tools to tackle this old enemy" (The Guardian, 8/16/2022)Read more coverage about vaccine-derived polio:"What to know about polio, a disease once again vying for attention" (STAT, 7/26/2022)“New polio cases highlight the urgency of eradication” (Think Global Health, 8/16/2022)"Polio was almost eradicated. This year it staged a comeback." (The New York Times, 8/18/2022)"Polio spread in Israel, US, UK highlights extremely rare risk of oral vaccine" (The Times of Israel, 8/21/2022)“Polio Is Exploiting a Very Human Weakness” (The Atlantic, 9/16/2022) Read more about nOPV2:"New polio vaccine against strain that threatens eradication is safe and generates immune response" (MedicalXpress, 12/10/2020)"WHO nod to first emergency use vaccine can tackle rising vaccine-derived poliovirus cases" (Down to Earth, 12/16/2020)“Independent experts advise move to next use phase for novel oral polio vaccine type 2” (GPEI press release, 10/10/2021)"The polio threat continues to grow—but a new vaccine could make a difference" (Time, 8/31/2022)“Supply issues a major challenge to polio vaccination programs” (MedPage Today, 10/4/2022)“Opinion: The US needs to prepare to introduce the novel oral polio vaccine” (The BMJ, 10/4/2022)Read more about polio funding:"Opinion: Polio eradication is in sight. Don’t stop funding it now" (STAT, 10/16/2022)“Gates Foundation pledges $1.2B to eradicate polio. Here’s why it’s been a struggle for decades” (Associated Press via PBS News Hour, 10/16/2022)“Bill & Melinda Gates Foundation pledge $1.2 billion to eradicate polio” (Reuters, 10/17/2022)“Global leaders commit $US2.6 billion at World Health Summit to end polio” (UNICEF press release, 10/18/2022)More information about World Polio Day can be found here.

PATH/Will Boase

October 17, 2022

Research Roundup: Monkeypox treatment trial, Sudan Ebola vaccine trial, Biosafety laboratory investments

Written by Hannah Sachs-Wetstone / GHTC

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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. The National Institute of Allergy and Infectious Diseases and the Democratic Republic of the Congo’s National Institute for Biomedical Research are co-leading a clinical trial evaluating the safety and efficacy of the antiviral drug, tecovirimat (TPOXX), in mitigating symptoms and preventing serious outcomes in 450 adults (including pregnant individuals) and children with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States. The drug impedes the spread of virus in the body by preventing virus particles from exiting human cells. Trial participants will be randomly assigned to receive the oral pill or placebos twice daily for two weeks. The World Health Organization (WHO) has announced that a clinical trial of vaccines aimed at preventing the rare Sudan strain of Ebola could start within weeks, pending regulatory approvals from the Ugandan government. There is no vaccine for the Sudan strain, which is behind the rapidly growing outbreak in Uganda. The trial will test two vaccines in development that have shown potential to treat this strain. Details about the specific vaccine candidates were not released. While the Sudan strain is less transmissible and has had a lower fatality rate in past outbreaks, compared to the Zaire strain, the Ugandan outbreak is incredibly concerning, and vaccines are urgently needed. By raising public awareness of emerging diseases and the need for laboratory capacity to address them, COVID-19 has inspired several Asian countries, including India, to invest in advanced biosafety laboratories. These labs are needed for working on dangerous pathogens and live viruses like SARS-CoV2. Some researchers have expressed concerns about the high cost of maintaining these facilities due to extensive safety measures including extra security, self-closing doors, and filtered air, among others. Concerns have also arisen about the potential risk of these labs handling extremely dangerous pathogens, however new labs could also improve overall safety practices that would reduce this risk. These new labs could play an important role in supporting more vaccine research, including for endemic infectious diseases in the region, as well as improving working conditions for researchers.

US President's Malaria Initiative/Samy Rakotoniaina

October 17, 2022

Developing new antimalarial drugs for malaria-free pregnancies

Written by Myriam El Gaaloul, Maud Majeres Lugand, and Doreen Akiyo Yomoah / Medicines for Malaria Venture

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Malaria in pregnancy threatens the health of mothers and babiesWhen a woman finds out she is pregnant, it is often an exciting, emotional, and nerve-racking time. For women in malaria-endemic countries, however, there is an additional concern: the risk of contracting malaria during pregnancy. This was a major worry for Kenyan mother Elyne Kaingu. Fortunately, during her second pregnancy, she received intermittent preventive treatment of malaria in pregnancy (IPTp) at the health clinic, enabling her to have a malaria-free pregnancy. However, not all women are as fortunate as Kaingu.According to the World Health Organization’s (WHO’s) 2021 World Malaria Report, 34 percent of the more than 33 million pregnancies worldwide in 2020 were exposed to malaria, meaning more than 11 million women and babies were at risk for the serious complications that malaria in pregnancy (MiP) may entail, including anemia, the development of severe malaria, and risk of miscarriage or low infant birth weight. Insufficient prevention and treatment options for MiP Despite the urgent need, options for preventing and treating MiP are currently limited. Pregnant women are usually excluded from clinical trials to protect them and their babies from potential adverse effects of new drugs in development, making it difficult to determine the safety and appropriate dose to guide recommendations of new and existing drugs for use in pregnant women. While WHO recommends artemisinin-based combination therapies (ACTs) to treat uncomplicated malaria and sulfadoxine-pyrimethamine (SP) for IPTp for women in their second and third trimesters, these treatments fall short in some critical areas: neither is recommended for use in the first trimester of pregnancy1 and SP should not be used by pregnant women with HIV/AIDS receiving prophylaxis against opportunistic infections or by women in areas where SP drug resistance is reported.Protecting and treating pregnant women: Researching, repurposing and recombining antimalarials To improve the availability of well-tolerated and effective antimalarials for pregnant women, changes in drug development approaches are urgently needed. Through MMV’s MiMBa strategy, the product development partnership is advocating for and advancing several innovative research approaches.What has first been required is a mindset shift—a clear agreement to change the way we approach de-risking of compounds so that there is robust data on pregnancy as soon as possible in the drug development process. Starting at the earliest phase (discovery), MMV is prioritizing new antimalarials for progression to development based on their low-risk profile for birth defects. In addition, MMV is using translational pregnancy models to optimize and accelerate their clinical development by providing information on the potential need to adjust drug dosing for pregnant women, as well as the possibility of fetal exposure. Further, MMV performs developmental and reproductive toxicity studies that evaluate the effects of potential drugs on one complete life cycle (from conception in one generation through the following generation) earlier in the development process. Compounds which are shown to be well-tolerated in developmental and reproductive toxicity studies will be evaluated in pregnant women. It is hoped that if compounds can be appropriately de-risked, then in future dedicated clinical trials in pregnancy might be conducted in parallel to phase 3 trials, also known as confirmatory studies, which “aim to confirm the efficacy and safety of the candidate compound in a large patient population.” This approach would allow for the collection of information to establish the benefit/risk balance of a new antimalarial at an earlier stage and will help ensure that the needs of pregnant women are addressed in a more timely and equitable manner in the future.Existing antimalarials: Filling the data gapMMV has undertaken research on existing drugs for their potential use in pregnant women. With its pharmaceutical partner Shin Poong and other research partners, MMV conducted a real-life study (CANTAM) on pyronaridine-artesunate (Pyramax®) in five countries in Africa with results indicating high safety, tolerability, and efficacy for the 11 women who were unknowingly pregnant. Finally, MMV is currently providing input in an ongoing study, PYRAPREG, led by the University of Sciences, Techniques and Technologies of Bamako, which is looking at the efficacy and safety of four ACTs, including Pyramax, in the second and third trimesters of pregnancy. Further, MMV is supporting follow-up studies on ACTs already on the market. For example, MMV and the Liverpool School of Tropical Medicine’s Timika facility in Indonesia continues to monitor women during and after their pregnancies.Finally, MMV has set up a pregnancy registry, launched last year in Kenya with the Liverpool School of Tropical Medicine and extended to Burkina Faso at the beginning of 2022. Through this registry, MMV aims to obtain robust data on the use of a range of ACTs for the treatment of uncomplicated malaria in pregnancy. The information generated will serve to better understand the benefit/risk ratio and contribute to informing policymakers, regulators, clinicians, and pregnant women on the use of ACTs, particularly during the first trimester. According to Hellen Barsosio, a senior clinical research scientist based in Kenya, “Pregnancy registries are vital in providing safety information on drugs and vaccines used during pregnancy, particularly within the first trimester, a critical period for the growing baby due to the limited safety data available by the time drugs reach the market.”Facilitating access to antimalarialsFor antimalarials to be useful in preventing and treating MiP, healthcare workers and patients must be aware of their protective effects and be able to access them. MMV works with governments, pharmaceutical companies, and implementing partners to ensure that antimalarials are available as quickly as possible after launch, especially in hard-to-reach areas. A recent success in facilitating access to antimalarials for pregnant women is the achievement of WHO prequalification for SP by Universal Corporation Ltd, a Kenyan pharmaceutical company, supported by Unitaid and MMV. Universal Corporation Ltd is the first pharmaceutical company in Africa to achieve prequalification for SP. As alternatives to SP advance, it will be crucial to enable manufacturers in endemic countries to produce quality-assured medicines so that they are readily available for pregnant women. The World Health Summit serves as a reminder that those who are the most vulnerable to diseases must be at the center of drug discovery and development efforts. Developing antimalarials to address the needs of pregnant women is vital to achieving malaria eradication by ensuring that everyone can access the care they need. 1. On 25 November, WHO released its updated guidelines for malaria, which include a strong recommendation for the use of an ACT, artemether-lumefantrine, to treat uncomplicated malaria in women in their first trimester

PATH/Matthew Dakin

October 10, 2022