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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 phase 3 clinical trial of Valneva’s single-shot chikungunya vaccine is now complete, the company announced last week, with analysis confirming a high level of protection and strong immunogenicity profile. One month after receiving the live-attenuated, single-dose shot, 98.9 percent of participants achieved protective levels of neutralizing antibodies against chikungunya virus, and after six months, 96.3 percent of participants showed protective neutralizing antibody titers against the virus. The results represent the first final phase 3 trial data for a chikungunya vaccine candidate. Valneva expects to start the pre-submission process with the US Food and Drug Administration in the second quarter of this year.An investigational antimalarial drug showed effectiveness against blood-stage Plasmodium falciparum malaria in its first stage of human testing, according to new analysis published in The Lancet. The drug, ZY19489, was found through a screening of around 500,000 compounds conducted by AstraZeneca and the Medicines for Malaria Venture. After demonstrating activity at the blood stage of infection in preclinical studies, the phase 1 trial was conducted to evaluate optimal dosing, assess effects of food intake on oral absorption and kinetics, and confirm the parasite was cleared without developing treatment resistance. The drug would likely need to be used in combination with another agent and with possible additional doses to attain a curative regime, but its demonstrated safety, pharmacokinetic profile, and antimalaria activity support its further development as a novel therapy, researchers said.Global leaders and stakeholders last week pledged a total of US$1.535 billion to the Coalition for Epidemic Preparedness Innovations (CEPI) to implement its five-year plan to prepare and protect against emerging diseases with pandemic potential. The five-year road map, for which CEPI has a total budgetary ask of $3.5 billion, includes plans to compress vaccine development to 100 days, develop a broadly protective vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. In addition to monetary pledges, the Global Pandemic Preparedness Summit brought announcements on several research collaborations and commitments, including a partnership to develop a pan-coronavirus vaccine.

International Women’s Day calls for action to address biases, discrimination, and inequities that continue to impact the quality of life of women and girls, including their access to healthcare, such as malaria prevention and treatment. Pregnant women and their babies are among the most at risk from malaria, and this is exacerbated by their limited access to antimalarial medicines. According to the World Health Organization (WHO), in 2020, nearly 12 million pregnant women were exposed to malaria, and they are particularly vulnerable as pregnancy can weaken their immune system. Malaria can have devastating effects on pregnant women and infants, from mothers with severe anemia and babies born with low birth weight to, in the worst case, the death of the mother and/or baby. According to research from 2020, one in ten maternal deaths in malaria-endemic countries is the result of malaria. WHO recommends intermittent preventive treatment in pregnancy (IPTp) to prevent malaria in pregnancy. Ideally, eligible pregnant women should receive three doses of sulfadoxine-pyrimethamine (SP) to prevent malaria in their second and third trimesters for optimal protection. Due to several factors, only 32 percent of eligible pregnant women received all three recommended doses of IPTp in the 33 sub-Saharan African countries assessed by WHO’s 2021 World Malaria Report. A 2019 review that looked at determinants of IPTp uptake in 18 sub-Saharan African countries found that poor policy implementation resulting from weak coordination between national malaria control and reproductive health programs and stockout of quality SP were the main barriers. The review also mentioned the pivotal role played by health providers in delivering IPTp, highlighting the correlation between their awareness of the policy and the IPTp coverage. In sub-Saharan Africa, between 70 and 90 percent of pharmaceuticals are imported, making it difficult to ensure a steady supply of treatments like SP. To help remedy this access gap, Medicines for Malaria Venture (MMV) is currently leading a UNITAID-funded project to enable the pharmaceutical companies Universal Corporation Ltd (Kenya), Swipha/Biogaran (Nigeria) and Emzor (Nigeria) to manufacture quality SP, not only for domestic use, but also for other countries in Africa. Community IPTp (C-IPTp) is another solution to help address the access gap, in which pregnant women visit “purposely trained and supervised, easily accessible community health workers” close to their homes to receive IPTp. C-IPTp is being explored by many countries with promising results in improving SP uptake. MMV is also involved in Transforming Intermittent Preventive Treatment for Optimal Pregnancy, otherwise known as TIPTOP, a Jhpiego-led project to increase the number of women able to benefit from C-IPTp.Under the umbrella of the Roll Back Malaria Partnership, MMV is participating in a signature campaign calling for global leaders to Speed Up Scale-Up IPTp through an open letter that asks for increased funding to address malaria in pregnancy, proper training for health care workers and the removal of the previously mentioned barriers to seeking care. Beyond statistics: Surviving malaria in pregnancy The need for new options for medicines is underscored by Eileen Buxton’s experience. Eileen, a Ghanaian nurse, was already aware of the risks of malaria in pregnancy as a health care worker in an endemic country. After falling ill while pregnant herself, Eileen “was scared… I knew how being sick during pregnancy could affect the mother and the child too.” She was admitted to a hospital for treatment. After her release, however, the fever came back within a couple of days. Eileen was experiencing severe malaria and had to be admitted to the hospital again, this time for about three weeks. “It took a long time for me to recover some strength,” she recalls. Despite this harrowing experience, Eileen can be described as one of the fortunate ones: after her recovery, she gave birth to healthy twin babies. Millions of women are not so lucky. Scaling up IPTp-SP access will prevent millions of women from going through experiences like Eileen’s. While International Women’s Day highlights women’s achievements, it is also a reminder of the existing challenges they face. When it comes to health and malaria specifically, it is also a reminder that we have not yet reached equity. Ending malaria means working to provide access to antimalarial prevention and scaling up access to IPTp and other treatment methods that are effective and safe for all people—like Eileen Buxton—who are most at risk. Ultimately, that’s a win for everyone. We urge you to add your name to the open letter and help protect more mothers and babies from malaria.

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 Pfizer-BioNTech COVID-19 vaccine’s effectiveness among children ages 5 to 11 wanes over time but continues to protect against the most severe outcomes, according to new real-world evidence released last week. Analysis from the US Centers for Disease Control and Prevention, summarizing data from ten states, suggested that while vaccine effectiveness faded during omicron and generally decreases relative to the time since vaccination, the vaccine was protective against hospitalization and death in 5-to-17-year-olds, even after omicron emerged. A preprint study by the New York State Department of Health, also published last week, showed a substantial decline in protection among the younger age group in the state, including a significant decline in protection against hospitalizations. The new data comes amid developments involving vaccines for children under 5, which the US Food and Drug Administration plans to wait to review until data on third doses is available.The Biden administration plans to share government-backed COVID-19 technology with the World Health Organization (WHO) to help bolster access to medicines in low- and middle-income countries. The technologies, developed by the National Institutes of Health (NIH), would be licensed to the WHO’s COVID-19 Technology Access Pool as well as sublicensed through the United Nations-backed Medicines Patent Pool. Details on which technologies would be made available through the deal are still being determined, but the policy is not intended to apply to vaccines and therapeutics in the US market developed by private companies. Sharing NIH-devised technologies is meant to allow other countries to replicate the manufacturing process and therefore more quickly boost the global stockpile of pandemic supplies.On Wednesday, a WHO panel backed the use of Merck & Co., Inc.’s COVID-19 antiviral pill for high-risk patients. The recommendation, based on new data from six clinical trials involving 4,796 patients, conditionally endorses the pill, molnupiravir, for use among patients with non-severe disease who are at high risk of hospitalization. This could include immunocompromised individuals, the unvaccinated, older people, and those with chronic diseases. No recommendation has been made for use of the pill among patients with severe or critical illness, as there is no trial data for the group. The WHO panel is also preparing recommendations for Pfizer’s COVID-19 antiviral pill, Paxlovid.