Research Roundup: Antiviral pill proves effective, open-source antiviral project gets funding boost, and Sanofi to pivot mRNA program

This blog is authored by Abena Poku-Awuku, Silvia Ferazzi, Katya Halil, and Maud Majeres-Lugand of Medicines for Malaria Venture; Valentina Buj de Lauwerier, Clara Pons-Duran, and Joanna Lai of UNICEF; and Clara Menéndez and Raquel González of ISGlobal.From the turn of the millennium until 2015, the global health community has successfully reduced malaria-related deaths by 60 percent and decreased the likelihood of malaria infection among the 3.4 billion people at risk. However, since then, progress has stalled, and in 2019, malaria claimed the lives of approximately 409,000 people, 90 percent of whom lived in sub-Saharan Africa (SSA).As children under 5 years of age and pregnant women are the hardest hit by the disease, most efforts are targeted at protecting these groups. It has been widely reported that malaria still kills a young child every two minutes in SSA. However, less well-known is that, as of 2016, malaria was also the second major cause of death and ill health, after HIV/AIDS, in younger adolescent girls aged 10–14 in the region. Malaria was also the eighth cause of death and the fifth leading cause of ill health among all adolescent girls in SSA. Furthermore, while gains were made in global malaria control between 2012 and 2016, especially among children under the age of 5, little progress was made in reducing malaria-related deaths among adolescents. The protection of populations such as adolescents, and particularly girls, has been largely overlooked due to lack of age- and sex-disaggregated data. For instance, the most recent publicly available data on malaria-related death and ill health among adolescents is from 2016. ISGlobal, Medicines for Malaria Venture, and UNICEF are collaborating to raise awareness of the lack of evidence and information on the vulnerability of adolescent girls to malaria, as well as bring attention to the specific challenges adolescent girls face in accessing malaria protection and treatment interventions.Why are adolescent girls more at risk of malaria?Biologically, younger adolescent girls and pregnant adolescents, especially those in their first pregnancies, have been found to be at higher risk of malaria and anemia than adolescent boys and older pregnant women. An estimated 777,000 girls under the age of 15 and 12 million girls aged 15–19 get pregnant each year in developing regions; malaria and associated anemia can be deadly for both the young mother, her fetus, and her newborn child.Socially, in many malaria-endemic countries, gender-based roles and household hierarchies, as well as the false notion of being less vulnerable to the disease, all raise an adolescent girl’s risk of being infected with malaria. Moreover, adolescent girls often do not have financial resources, may be unaware of their civil rights, and lack information about the disease. Age-of-consent policies equally prevent adolescents, both boys and girls, from seeking health services without the consent of a parent or guardian, or a spouse in the case of girls.The situation is exacerbated when a girl becomes pregnant, because she is less likely to access services due to cultural bias and stigma. For instance, intermittent preventative treatment of malaria in pregnancy is an antenatal care intervention recommended by the World Health Organization (WHO) in SSA to protect all pregnant girls and women against malaria. However, reaching pregnant adolescents with this intervention is difficult, as they are less likely to access antenatal services than women and older adolescents due to societal stigma.Furthermore, when a pregnant girl or woman becomes infected with malaria, very few effective malaria treatment options are available to her. Artemisinin-based combination therapies for P. falciparum malaria, the most common form of malaria in SSA, have only recently been considered by WHO for the treatment of malaria during first-trimester pregnancy, but WHO emphasizes the need for continued monitoring of drug safety, birth outcomes, and death among newborns. In addition, P. vivax malaria, a form of malaria that is predominantly found in Southeast Asia and Latin America, has now been found across Africa and is increasingly growing in parts of East Africa. However, the existing radical cure for relapsing P. vivax malaria is not recommended during pregnancy. Moreover, the development of new antimalarials for pregnant girls and women is constrained, because current drug development processes actively exclude pregnant women and girls during the development of new antimalarial drugs. This hinders the generation of data and creates evidence gaps in the treatment of malaria in pregnant women and girls. Insufficient funding is also a major limiting factor to the research and development (R&D) of new antimalarial drugs for pregnant girls and women. Engaging policymakers and the wider malaria communityBased on existing, but limited, evidence, we urge policymakers and the wider malaria community to join forces in: Developing adolescent-friendly school- and community-based services that facilitate improved outreach to adolescent girls and take into consideration their perspectives and needs. Increasing resources for information, education, and communication on the impact of malaria will also be impactful.Working together with local communities and health workers to build safer environments that encourage girls to access health services, including malaria and reproductive health interventions. Advocating against early marriages and early pregnancies, as key compounding obstacles to a self-determined and healthy, disease-free life.Maintaining the continuum of care for pregnant girls through preconception, prenatal, and postnatal stages to ensure that malaria is eliminated in this group. Supporting the generation of updated and in-depth evidence to back the development and re-evaluation of policies and programs targeting adolescents and focusing on gender equity. Revising national policies that set age limits and create barriers to accessing health services and malaria interventions. Increasing funding for malaria R&D projects to design effective interventions for pregnant girls. Developing new approaches, including leveraging new technologies, to facilitate earlier inclusion of pregnant women in clinical trials.

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 Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.