Breakthroughs Blog: Child health

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. A new phase IV observational study will test whether a novel approach to managing severe malaria, involving interim treatment with rectal artesunate, could address the challenge of treating those with severe cases in isolated rural settings far from a health facility. In the study, patients will be treated with artesunate rectal capsules at the community level and evaluated for clinical outcomes and then will receive follow up treatment with oral artemisinin-based combination therapies once they are well enough to swallow the medicine. The study, led by the newly created Severe Malaria treatment with Rectal artesunate and Arteminisin-based Combination Therapy [in remote settings] (SEMA ReACT) consortium, is intended to generate evidence to inform gaps in guidance on how to approach treatment when it is not feasible to transfer severely ill patients in timely manner to high-level health facilities as current guidance recommends.The results from a new study coordinated by the Drugs for Neglected Diseases initiative (DNDi), the Japanese pharmaceutical company Eisai, and the Mycetoma Research Center in Khartoum found that the oral drug fosravuconazole is up to 85 percent effective in treating the neglected tropical disease mycetoma and has no side effects. Currently, mycetoma is treated with itraconazole, a drug which needs to be taken with food four times a day for a year, has a myriad of side effects, is expensive, and is not available in all endemic countries. In contrast, fosravuconazole, only needs to be taken once a day without food, is inexpensive, and already widely used to treat fungal nail infections—factors that enhance its suitability for widespread use in low-resource settings.The Global Antibiotic Research & Development Partnership (GARDP) has been awarded around $3.07 million from the Research Investment for Global Health Technology Foundation to support an international clinical trial to evaluate three novel antibiotic regimens for neonatal sepsis. This infection affects over 3 million newborns every year, most of whom live in low- and middle-income countries. The trial, run by GARP and partners, is underway in Kenya and South Africa and will expand to more countries next year. The funding will also enable GARDP to collaborate with South Korean Jeil Pharma to explore options to optimize the manufacturing and approval of the novel antibiotics included in the regimens under study to ensure affordable prices and stable supplies of the drugs.

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. Pfizer and BioNTech last week reported promising early-phase data on an mRNA combination vaccine against COVID-19 and influenza and announced plans to start a phase 3 trial of the vaccine, following Moderna’s similar announcement for its combination vaccine earlier this month. Moderna’s trial began last week, with Pfizer and BioNTech’s likely to start in the coming months as well. A combination vaccine for COVID-19 and influenza has the potential to greatly reduce the burden of these respiratory viruses on patients, providers, and health care systems, underscoring why these companies and the broader research community have placed a greater focus on combination vaccines coming out of the pandemic.At the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) last week, the World Health Organization reported the results of a major evaluation of a pilot rollout in three African countries of RTS,S, the first approved malaria vaccine, showing positive findings about the lives it has already saved. RTS,S cut deaths among young children by 13 percent over nearly four years and cut cases of severe malaria by 22 percent among kids young enough to have received a three-shot regimen. The RTS,S vaccine is notably not a perfect tool, given the limited durability of its protection and lower efficacy, but health experts say this data makes a strong case for broader rollout of RTS,S and the potential of integrating the second approved malaria vaccine, R21, into multipronged efforts to fight malaria.A research team at the Johns Hopkins Bloomberg School of Public Health has shown for the first time that human volunteers can be safely and effectively infected with Zika virus, which could benefit research efforts to gain a greater understanding of the disease and to develop vaccines and treatments to use against it, as none currently exist. This controlled human infection model is useful for research because during the 2015-2016 outbreak, researchers were unable to test experimental products in time before the epidemic subsided, and since, there have not been any large outbreaks. The new model is controversial but has been ruled by US regulators and the World Health Organization as safe and scientifically important.

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, a landmark study published in The Lancet Infectious Diseases confirmed that the benefits of combining the RTS,S malaria vaccine with preventative antimalarial drugs in settings of high seasonable malaria transmission continue over five years. Specifically, the study found that the vaccine-drug combination reduced severe malaria cases and deaths in young children by nearly two-thirds compared to either RTS,S vaccination or seasonal malaria chemoprevention alone and that the efficacy of RTS,S in preventing malaria in highly seasonal settings was similar to seasonal malaria chemoprevention. These results underscore the importance of integrating multiple prevention tools into existing malaria control efforts to alleviate the remaining burden of malaria.The US Department of Health and Human Services (HHS) announced recipients for the first $1.4 billion round of funding for Project NextGen, the successor to Operation Warp Speed, which includes awards to develop more effective and longer-lasting COVID-19 vaccines, a new monoclonal antibody, and technologies to streamline manufacturing. Regeneron, the Global Health Investment Corporation, and Johnson & Johnson Innovation are among the first group of recipients. HHS said these awards are a catalyst to kick staff research and anticipates announcing additional awards for the $5 billion program by the end of the year.  The US Food and Drug Administration (FDA) last week approved Abrysvo, Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant people, which is aimed at protecting newborns from the virus in their first six months of life. The announcement follows the agency’s approval of Abrysvo for adults 60 and older. The US Centers for Disease Control and Prevention is expected to recommend the vaccine soon, hopefully setting the country up for a healthier fall and winter season ahead with AstraZeneca and Sanofi’s Beyfortus RSV monoclonal antibody for infants also approved earlier this summer and updated COVID-19 shots expected in the coming weeks. 

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 month, Brazil became the first country in the world to introduce tafenoquine, the first new single-dose treatment for P. vivax malaria developed in 70 years. Tafenoquine, developed by GSK and Medicines for Malaria Venture (MMV) in partnership with local researchers in Brazil, improves upon the previous treatments, which had major issues with adherence due to higher complexity and longer duration. The local Brazilian research partners also developed a new point-of-care test to identify a hereditary condition that can cause hemolytic anemia in those who take tafenoquine or one of the previous treatments, primaquine. After the approval and registration of tafenoquine in Brazil in 2019, field studies conducted over the last few years found extremely high levels of compliance with the new treatment protocol of routine testing to inform treatment, and similar feasibility studies are starting around the world, which will hopefully provide further evidence to improve global and national malaria guidelines and programs.The world’s first trial for a potential treatment for Crimean-Congo hemorrhagic fever has launched in Turkey. There are currently no specific approved drugs or vaccines and limited funding for R&D for the virus, which was named a priority pathogen by the World Health Organization. It is endemic in many countries in Africa, the Middle East, and Asia and has a mortality rate as high as 40 percent. The phase 1 trial will test the safety and potential dosages of two different drugs in multiple combinations, hopefully leading to more advanced trials or at least initiating momentum for more research to address the virus.This week, the US Food and Drug Administration approved a monoclonal antibody, Beyfortus, to protect infants and young children from respiratory syncytial virus (RSV). The single-injection antibody therapy, developed by AstraZeneca and marketed in the United States by Sanofi, showed strong results in phase 3 clinical trials. If the treatment gets a further recommendation from the Centers for Disease Control and Prevention, the drug could greatly reduce hospitalizations and deaths caused by RSV, which is the leading cause of hospitalization of babies in the United States. Beyfortus, has already been licensed in the European Union, the United Kingdom, and Canada, and other technologies for RSV, including a vaccine for pregnant people are also aiming to reduce the global burden of the virus.