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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. Novavax’s COVID-19 vaccine showed 90 percent efficacy in preventing laboratory-confirmed symptomatic infection among adults aged 18 and older, according to phase 3 trial results released last week. The vaccine was also 91 percent protective in high-risk populations, 93 percent protective against variants of concern and variants of interest, and completely protective against hospitalization and death due to COVID-19. The recombinant protein vaccine is given in two doses, three weeks apart, and can be stored at refrigerator temperatures. Novavax plans to file for authorization with several drug regulators, including the US Food and Drug Administration (FDA), in the third quarter and expects to be able to produce 100 million doses a month by the end of that quarter followed by 150 million per month by the end of the year. Novavax also has an agreement with Gavi, the Vaccine Alliance, to deliver 1.1 billion doses of its vaccine, once authorized, to the COVAX vaccine-sharing facility.In new data from the UK Recovery Trial, Regeneron’s antibody cocktail reduced the chance of death among hospitalized COVID-19 patients who haven't produced their own antibody responses to the disease. The study showed REGEN-COV reduced risk of death by 20 percent among seronegative participants, or those who produced no natural antibody response, while for patients who had developed antibodies, the treatment didn't work at all. Among the seronegative group, the treatment also reduced the average hospital stay by four days and decreased the chance of a patient requiring a ventilator. REGEN-COV received emergency use authorization from the FDA late last year for patients with mild to moderate COVID-19 and recently received an expanded green light for a lower dose and delivery by subcutaneous injection. Regeneron now intends to take the new data to the FDA for expansion to use in seronegative hospitalized patients.CureVac’s two-dose mRNA COVID-19 vaccine was 47 percent effective against COVID-19 disease of any severity among participants in a 40,000-person trial, interim analysis shows. The broad diversity of variants makes it challenging to demonstrate high efficacy, according to a statement from CureVac’s chief executive—13 variants were recorded in the trial, with only a single case caused by the original SARS-CoV-2 virus. More than half of the cases were infections with variants of concern. The trial, conducted in ten countries in Latin America and Europe, will continue, and final data is expected in the coming weeks. The CureVac vaccine is of most importance to the European Union, which has preordered 225 million doses, with the option to buy 180 million more.

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.