Breakthroughs Blog

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 US Food and Drug Administration (FDA) on Thursday approved updated COVID-19 vaccines from Pfizer and Moderna that target the KP.2 virus strain, which emerged from the highly contagious JN.1 variant that began circulating widely in the United States last winter. The new shots are expected to be available within days amid spiking case rates and hospitalizations for COVID-19. Experts also hope the vaccines will provide cross-protection against closely related subtypes of the virus, including KP.3.1.1 and KP.3, which are now spreading rapidly and account for 36 and 17 percent of all new cases, respectively. The FDA has not yet approved a third vaccine from drugmaker Novavax.The World Health Organization (WHO) this week recommended three new oral regimens for multidrug-resistant or rifampicin-resistant tuberculosis (TB) that can cure patients more quickly and successfully than the current painful injectable regimens. These regimens—which include the use of new and repurposed medicines like bedaquiline, pretomanid, linezolid, and delamanid—can be offered to nearly all patients and can improve treatment success by shortening treatment time to six to nine months, rather than the usual 18 months, while reducing treatment toxicity and the spread of drug-resistant forms of TB. WHO’s recommendations are based on results from the BEAT-TB clinical trial conducted in South Africa and the endTB trial conducted in seven countries between 2017 and 2023 by Médecins Sans Frontières, Partners In Health, and Interactive Research and Development and funded by Unitaid.  A new study found that giving azithromycin to all children up to five years old can greatly reduce childhood mortality in sub-Saharan Africa, more so than by limiting the distribution of the antibiotic to younger children, as recommended by WHO. The study, published Wednesday in the New England Journal of Medicine, found that twice-yearly distribution of azithromycin to children ages 1 to 59 months in rural communities in Niger reduced childhood mortality by 14 percent when compared with children who received a placebo. Further, the study found that targeting only children ages 1 to 11 months (recommended by WHO in 2020) did not lead to a significant reduction in childhood mortality. However, concerns remain about the effect of routinely distributing the antibiotic to all children under five on antimicrobial resistance. 

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 recently published study found that a malaria vaccine candidate given to women who planned on becoming pregnant was safe and effective for both the women and their babies. This exciting research could lead to a vaccine to protect pregnant individuals— who are often excluded from clinical trials—and their babies from malaria in the face of an estimated 50,000 maternal deaths and 200,000 stillbirths every year caused by malaria infections in pregnancy. The investigational attenuated vaccine, PfSPZ, will next be tested for use during pregnancy and in a larger study on preconception use. Just as the World Health Organization and the Africa Centres for Disease Control and Prevention declared the current mpox outbreak a public health emergency last week, SIGA Technologies and the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health reported mixed results from a preliminary analysis of a study testing the smallpox antiviral treatment Tpoxx against mpox. While the study, which took place in the Democratic Republic of Congo and began during the 2022 global outbreak, did not meet the trial’s primary endpoint of reducing the time to lesion resolution within a 28-day treatment period, the company says these results are not entirely unexpected and is highly encouraged that Tpoxx did elicit a “meaningful improvement” in some participants with severe cases, supporting a potential use case as post-exposure treatment for patients with severe mpox. The company also pointed to four other ongoing studies that significantly differ from the Congo trial and will provide additional data on the treatment.The NxTAG Respiratory Pathogen Panel, which detects and differentiates between common respiratory viruses, recently received 510(k) clearance from the US Food and Drug Administration. The combination test, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA) can, from a single swab, detect and differentiate 19 common respiratory viruses, including the virus that causes COVID-19, influenza A and B, and RSV, allowing health care workers to test patients and provide appropriate treatment rapidly. BARDA’s support is part of a broader effort to advance diagnostic testing platforms that can be rapidly adapted to emerging threats.

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 Africa Centres for Disease Control and Prevention (Africa CDC) is expected to declare its first-ever “public health emergency of continental security” as the mpox outbreak in sub-Saharan Africa continues to grow—with 14,000 cases and 511 deaths reported so far—and spread to countries that had never previously identified cases. The decision, a direct response to the global inequity faced by Africa during the COVID-19 pandemic, aims to mobilize international support and vaccine donations. Africa CDC has said that the need for vaccines greatly exceeds what is available and what many African countries can afford, with a costly price tag for the currently available vaccine. The United States has pledged almost $424 million to the Democratic Republic of Congo, where the outbreak started, as well as $10 million for the mpox response and 5,000 mpox vaccine doses. Japan, the European Union, and vaccine manufacturers are also preparing vaccine donations. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus announced last week that he will convene an emergency panel of experts to advise him on whether to declare the outbreak a global health emergency, which would garner even more attention and international support.Phylex Biosciences recently published the preliminary findings from an immunogenicity study conducted in collaboration with scientists from the US Centers for Disease Control and Prevention that showed promising results for a new mRNA nanoparticle vaccine against Nipah virus, a serious zoonotic disease that has an estimated case fatality rate between 40 and 75 percent. There is no preventive vaccine available for Nipah. The study found that the vaccine elicited a robust neutralizing response and confirmed the advantages of using mRNA and a nanoparticle, which allow, respectively, for quicker manufacturing and development timelines and efficacy after one dose. The company will next pursue clinical development for the vaccine candidate.Last week, WHO called for greater coordination on policies to strengthen the antibacterial pipeline as the global challenge of drug resistance, which disproportionately impacts low- and middle-income countries (LMICs), continues to rise. WHO highlighted the insufficient number of antibiotic candidates and limited innovative products in the fragile R&D antibacterial pipeline, as well as the lack of products in clinical development that address the evolving mechanisms of drug resistance, use oral formulations, and are formulated for infants and newborns, pointing to persistent R&D challenges like the dominance of small, resource-limited biotechnology companies in the sector. At the highest level, WHO called for greater global coordination and cooperation to improve data collection and sharing and ensure that efforts to boost R&D address the needs of underserved populations and LMICs. Specifically, WHO called on governments to provide adequate resources and incentives to boost the antibiotic R&D pipeline by addressing the needs of the small companies that dominate the sector and strengthening the capacity of the scientific communities and drug developers in LMICs.

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, Valneva and LimmaTech Biologics AG announced a new strategic partnership and exclusive licensing agreement for the development, manufacturing, and commercialization of Shigella4V, a tetravalent bioconjugate vaccine candidate against shigellosis. Shigellosis is caused by Shigella bacteria and is the second leading cause of fatal diarrheal disease globally, particularly in low- and middle-income countries. There are currently no approved vaccines for Shigella. Under the agreement, LimmaTech will receive support for conducting Phase 2 clinical trials of the vaccine candidate in low- and middle-income countries, which are expected to begin later this year. Then, Valneva will be responsible for the further development of the vaccine candidate through potential regulatory approval and commercialization if approved.The Biological Pest Control Centre in Valencia, Spain is releasing thousands of sterilized tiger mosquitoes, one of the species whose females transmit dengue to humans, to reduce the spread of dengue and other vector-borne diseases in Europe, as climate change has led to an expanding population of tiger mosquitoes across the continent and rising dengue rates globally. The lab employs an electron accelerator that uses radiation to sterilize the males, releasing an estimated 45,000 male mosquitos every week, who then unsuccessfully mate with the disease-spreading females, leading to an eventual reduction in the overall mosquito population. Similar sterilization techniques have been previously used to address disease vectors, but the Spanish lab is pioneering its use on the tiger mosquito.Last week, Indian company Biological E announced that the World Health Organization (WHO) has prequalified its novel oral poliovirus type 2 vaccine, a next-generation live attenuated oral vaccine, which can hopefully help reduce the incidence of vaccine-derived poliovirus, along with Indonesia PT Bio Farma's vaccine that was prequalified earlier this year. Cases of vaccine-derived poliovirus have increased in recent years in areas with low immunization rates. The new vaccine has improved genetic stability and carries a lower chance of starting new outbreaks of vaccine-derived virus compared to currently available poliovirus type 2 vaccines. Biological E said its manufacturing facilities can produce more than 500 million doses each year, with Indian regulators already having cleared the vaccine for export purposes.