Breakthroughs Blog: Medicines

For the second time, the World Health Assembly took place in the midst of an ongoing pandemic that is widening health inequities across and within regions. More than a year after the first wave of the pandemic, health systems in many parts of the world continue to battle waves of infection amid shortages of oxygen, vaccines, and health care workers. Yet among the numerous challenges posed by the pandemic, there were positive signals that with coordinated and focused action, health innovation in record pace is possible, particularly if that action can be built on a firm foundation of existing research and development (R&D). Our next challenge—as we continue the battle against COVID-19 and other health threats—is to channel similar coordinated, focused action to ensure the benefits of innovation are distributed equally across both geography and gender. What happens when years of existing research systematically exclude certain populations, denying them or delaying access to the benefits of health innovation? How can we address the underlying causes and accelerate shifts to make clinical research more inclusive? A recent side event at the 74th World Health Assembly, co-organized by Deutsche Stiftung Weltbevölkerung, Global Health Technologies Coalition, and Medicines for Malaria Venture (MMV), explored the above questions by highlighting the specific issue of gender inequity in health innovation. The panelists at the event discussed how gender biases have resulted in women’s underrepresentation in preclinical and clinical research, leading to downstream gaps in therapeutic options for them. Though gender inequity in health innovation is not limited to malaria, this article builds upon MMV’s presentation at the event, focusing on gender equity in malaria R&D to meet unmet needs. Unlike COVID-19, malaria is a disease that we have known for centuries. Despite the vast amount of scientific and epidemiological knowledge on malaria, a quick glance at the historical trajectory of malaria research reveals that it has been embedded in a larger context of gender bias in medical research. During the clinical development of most new medicines, including antimalarial drugs, pregnant people are actively excluded from trials and, if pregnancy occurs during the trial, treatment is discontinued and follow-up on the pregnancy outcomes is ensured. While this practice aims to protect the pregnant person and the fetus, it also prevents the generation of data and in doing so it has created knowledge gaps in the treatment of malaria in pregnant people. In addition to delaying the benefits of new treatments to these populations, the knowledge gaps also hinder the creation and implementation of gender-sensitive policies to fight the disease.Malaria in pregnancy, and more broadly in people of reproductive potential, remains a major public health challenge today. The World Health Organization estimates that 12 million pregnancies are at risk annually, resulting in nearly 822,000 children being born with low birth weight. Though preventive tools like vector control (for example insecticide-treated bednets and indoor residual spraying) and intermittent preventive treatment in pregnancy exist, there are very few treatment options for pregnant and lactating people in their first trimester. The longer we wait to change our course, not only do we risk losing thousands of pregnant people and babies to a treatable disease, but we also widen the existing knowledge gaps that urgently need to be bridged. In other words, if we delay the process of integrating a gender lens as an essential element of the drug development process, the journey to catch up will be steep and could jeopardize efforts to eliminate and eradicate malaria. Fortunately, there is a growing determination within the malaria community to rectify gender-related data gaps. At MMV, we are doing so through our Malaria in Mothers and Babies (MiMBa) strategy, which aims to systematically prioritize and address the needs of pregnant people and newborns, right from target product profiling at the outset of drug development through to ensuring a stable supply of recommended medicines to treat and protect these populations from malaria. In one example, recognizing the lack of safety and tolerability data for antimalarials used during pregnancy, we have teamed up with the Liverpool School of Tropical Medicine to develop a pregnancy registry to help fill the data gaps with the objective of eventually establishing standard protocols in the treatment of malaria during pregnancy in all endemic regions.Other organizations, like the WorldWide Antimalarial Resistance Network, are building online repositories of published and unpublished literature on malaria in pregnancy, contributing to the methodical archiving of data on this topic. Furthermore, awareness campaigns like “Zero malaria starts with me” are also placing a strong focus on the need for inclusive innovation to treat malaria in pregnancy.In an important step forward, high-level decision-making bodies like the G7 are also taking note of this issue. We welcome the G7 health ministers’ Therapeutics and Vaccines Clinical Trials Charter to pave the way for “stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children.” This is an important step forward toward more equitable clinical research.While great strides are being made in advancing health innovation to better represent and account for the needs of all genders in health care, much critical work remains to be done. Decades of exclusion from clinical research will not disappear overnight. The need of the hour is gender mainstreaming supported by significant investments into R&D, as well as moving policymaking forward, to ensure a fairer and more inclusive health care system for all. Most importantly, while organizations like MMV commit to extend the benefits of our innovation equitably to all populations affected by malaria, we firmly believe that the road to achieving gender equity in clinical research will be paved by the inclusion and support of patients, health workers, researchers, policymakers, as well as the champions and advocates for health equity in the global health system. Much like for the COVID-19 pandemic, catalyzing this transition to a gender-sensitive malaria eradication strategy will require focused and coordinated action and all voices have a part to play.

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.

Malaria is one of the world’s oldest and deadliest diseases. For generations it has devastated families, communities, and countries. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance, continue to hamper control efforts—underscoring the need for continued research and development of new tools. In recognition of #WorldMalariaDay, test your knowledge of this deadly foe and the innovations being advanced to #EndMalaria: Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k