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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. On Wednesday, the World Health Organization recommended broad rollout of the world’s first malaria vaccine, known as RTS,S, among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot program—which has reached more than 800,000 children in Ghana, Kenya, and Malawi since 2019—showing the vaccine’s safety and effectiveness in remote and rural settings. Clinical trials of RTS,S, which was developed by GSK and PATH with funding from the Bill & Melinda Gates Foundation, indicated it reduces the risk of contracting malaria by 40 percent and risk of hospitalization for severe malaria by 30 percent. The vaccine will now face funding decisions from the global health community for broader rollout and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.A new study has identified a compound able to block dengue virus replication in test tube experiments and in mice, researchers reported in Nature last week. There are currently no specific medicines to treat dengue, which infects more than 400 million people annually and can lead to fevers, rashes, and muscle and joint aches. Researchers behind the new study screened tens of thousands of small molecules for anti-dengue activity using an automated high-throughput testing process, then tweaked several molecules to produce more than 2,000 compounds for further testing. One of those drugs, JNJ-A07, proved equally potent against all four dengue serotypes in test tube experiments. In subsequent testing in mice, the compound was highly effective in reducing viral loads and viral-induced disease. The drug will be further tested in clinical trials for safety and efficacy in humans, according to developer Janssen Pharmaceutical Companies of Johnson & Johnson.The African Medicines Agency (AMA) treaty was ratified by its 15th African Union (AU) member country last week, meeting the threshold for the agency to be officially set up. The treaty was adopted by the AU in February 2019, though it required ratification and formal notification from 15 countries to launch implementation. Following Cameroon’s ratification on Tuesday, the AU now has 30 days, or until November 5, to begin setting up the agency, which is intended to support African countries in improving and harmonizing the regulation of medicines across the continent in order to improve access to quality, safe, and efficacious products. The AMA will be Africa’s second continental health agency, joining the Africa Centers for Disease Control and Prevention.

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. Merck plans to seek authorization for its COVID-19 antiviral pill after clinical trial results showed the drug, molnupiravir, cut the risk of hospitalization or death in half among high-risk individuals early in their infections. An independent board of experts monitoring the study data had recommended that the trial be stopped early because the drug’s benefit to patients had proved so convincing, and the US Food and Drug Administration agreed, according to Merck. The drug, designed to stop the virus from replicating, is taken as four capsules twice a day for five days. As an oral antiviral treatment, the pill could be a crucial new tool in combating COVID-19 by reaching more people than the antibody treatments being widely used in the United States.COVID Moonshot, an open-source effort to design a COVID-19 pill, has won US$11 million, or GBP£8 million, from the Wellcome Trust to develop a low-cost, broadly available antiviral to fight the pandemic. The project, coordinated by the Drugs for Neglected Diseases initiative, is a nonprofit consortium of scientists that began in March 2020 and led to around 250 people submitting more than 4,500 potential molecular designs intended to block the key protein that helps the virus replicate. The new funding, through Wellcome on behalf of the COVID-19 Therapeutics Accelerator, will help pay for the expensive last step of research needed to bring the project into human clinical trials. Moonshot hopes to have a compound able to be tested in humans by next year.Sanofi’s mRNA-based COVID-19 vaccine showed positive results in a phase 1/2 clinical trial, the company announced last week, providing confidence in its mRNA program that will now be used to pursue vaccines against other pathogens, including influenza. Sanofi will not be continuing to develop its mRNA COVID-19 vaccine, as the market will have been saturated by the time it would be authorized, the company said. In the preliminary phase 1/2 trial results, 91 percent of people who received the lowest tested dose saw their neutralizing antibody levels increase four-fold, a measure thought to equate to a protective level of antibodies, confirming that the mRNA platform is potent, can generate a strong immune response, and has no safety signal. Sanofi will now turn to accelerating its work on a vaccines “center of excellence” intended to be ready to produce vaccines when the next pandemic hits.