Breakthroughs Blog: WHO

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 Combating Antibiotic Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced that it will award up to $1 million to the company Scout to develop a rapid, inexpensive, and easy-to-use point-of-care diagnostic test for gonorrhea, which could expand access to testing and proper treatment in the face of a rise in gonorrhea cases and drug-resistant gonorrhea cases globally, especially in low- and middle-income countries. The test, STI-Scout, is designed to detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomitis and can provide results in only 30 minutes using urine samples or vaginal swabs at less than half the cost of other available tests. The test uses a proven isothermal technology that was validated for SARS-CoV-2 detection. Last week, EuBiologics and the International Vaccine Institute (IVI) announced that the World Health Organization (WHO) had prequalified Euvichol-S, an improved oral cholera vaccine produced with a simplified method that will hopefully help to address the rise of cholera outbreaks globally and a dire vaccine supply shortage. The vaccine, whose development was supported by the Bill & Melinda Gates Foundation, is produced in a way that can improve formulation and manufacturing productivity by 40 percent compared to the company’s prior oral cholera vaccine and demonstrated efficacy in a Phase 3 trial in Nepal last year. The prequalification paves the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for countries experiencing outbreaks.The New Nets Project, funded by Unitaid and The Global Fund to Fight AIDS, Tuberculosis and Malaria, recently reported results from several pilot studies showing that a pair of second-generation bed nets tested in malaria-endemic areas helped to prevent up to 13 million additional cases of malaria, saving close to 25,000 lives—exciting news that comes as malaria cases, as well as resistance to the standard insecticide used to treat nets, rise globally. The studies found that the new nets, the Interceptor G2 and Royal Guard—which both use dual insecticides to address resistance—were between 20 and 50 percent more effective than traditional nets, which only use pyrethroid insecticide, in reducing mosquito exposure and reduced the risk of infection by up to 55 percent. Although the new nets are more expensive, the additional cost seems to be offset by the public health savings of malaria prevention. Researchers expect malaria parasites to eventually become resistant to the new nets, highlighting the need for continued research into other methods of vector control, as well as ensuring population-scale protection through vaccination.

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. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.

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 first participants have been vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. Lassa fever is recognized by the World Health Organization (WHO) as a priority pathogen requiring accelerated research and causes an estimated 5,000 deaths each year, with the disease primarily affecting West Africa. There are no approved vaccines for Lassa currently. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and eventually an approved vaccine for routine immunization, as well as foster sustainable in-country research capacity and partnerships through engagement with Nigerian partners.Last week, FIND and LifeArc announced a new project in Kenya aimed at improving the detection and treatment of visceral leishmaniasis, a neglected tropical disease that mainly affects children and is fatal in more than 95 percent of cases if untreated. The project, which will run from 2024 to 2027, aims to increase early diagnosis and treatment to prevent disability and death from the disease in part by accelerating the development of new and improved diagnostic tests that are more sensitive than those currently available. The project will also build on ongoing efforts to improve community awareness, boost local and national testing capacity, and strengthen overall health system capacity.Last week, Cepheid announced that its point-of-care HIV test has received prequalification status from WHO. The decision will lead to the inclusion of the company’s HIV-1 PCR assay with extended coverage on a list of tests that meet WHO’s standards for global use, boosting access in low- and middle-income countries without designated or stringent regulatory authorities. The test can be used to detect HIV infection in infants and people who were recently infected and provides rapid results, enabling improved linkage to further care and treatment initiation.

GHTC welcomes the recent announcement by the World Health Organization (WHO) that it will apply parallel, rather than sequential, processes in developing guidelines recommending the use of novel health products and certifying their safety and efficacy via prequalification (PQ) and/or Emergency Use Listing (EUL). Many of our members and partners have highlighted how the prior procedure, which required guidelines to be in place as a prerequisite to EUL or PQ, was a major bottleneck for innovative products—adding significantly to approval timelines and delaying access to critical new health technologies in low- and middle-income countries.We believe that this new parallel process, which was first trialed during the pandemic for COVID-19 products, could significantly improve and accelerate access to vital innovative health technologies in countries that rely on WHO recommendations for the use of these products. We urge WHO to provide additional details on the implementation of this new process and encourage the PQ program to provide a platform for continued feedback and input from key stakeholders, including product developers, national regulators, procurers, and civil society.We believe that WHO’s PQ program continues to be an essential link in the regulatory ecosystem, and we hope this is just one of several steps WHO will take to reduce bottlenecks and improve the program’s efficiency and impact.