Hannah Sachs-Wetstone

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, the US Food and Drug Administration (FDA) announced that it is slowing down Emergency Use Authorizations (EUAs) of new in vitro diagnostics for COVID-19 and Mpox. The agency will continue reviewing tests that have already been submitted for authorization and is expected to review only some additional tests from experienced developers that use innovative technological approaches, fill a gap in need, or demonstrate potential for wide public health benefits. Instead, the agency is encouraging most developers to submit their tests through different review processes. Despite the end of the national emergency declaration for the COVID-19 pandemic on May 11, the 440 EUAs already granted will remain in effect as long as a separate agency-level EUA declaration determined by FDA continues.The World Health Organization (WHO) convened an emergency meeting of the Marburg virus vaccine consortium following the confirmation of the first-ever Marburg outbreak in Equatorial Guinea. During the meeting, five vaccine developers shared updates on their vaccine candidates for the disease. WHO is taking steps toward pursuing a real-time clinical trial for some of the candidates in alignment with the already-approved WHO clinical trial protocol for Marburg vaccines (which needs to be adapted to the country context) and in consultation with country officials. Sabin Vaccine Institute and Janssen’s candidates are in phase 1 clinical trials, while IAVI, Public Health Vaccines, and Auro Vaccines’ candidates are still in the pre-clinical development stage.A new study published last week found that a drug tested in mice could potentially be used as a birth control option for men. If successful in further trials, the drug would work as an on-demand contraceptive compared to other male contraceptives in the pipeline, like daily pills and gels, that researchers say are more complicated, time-consuming, and long-lasting. The drug works by preventing a molecular action from turning sperm “on” and activating them to pursue an egg. The researchers have founded a new company to move forward development of the drug but note it will likely be years before it is ready for testing in men.

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 recent study found that an inexpensive, widely available antibiotic could sharply reduce the number of pregnant individuals in low- and middle-income countries who develop sepsis in childbirth, which is among the three leading causes of maternal deaths globally. The study, conducted in seven countries mostly in sub-Saharan Africa and Asia, showed that a single dose of the drug azithromycin during labor cut the risk of the mother developing sepsis by around 35 percent. Azithromycin is a generic drug, it has a long half-life, and it does not require refrigeration, making it an inexpensive and easy-to-deliver tool that could be widely adopted even in low-resource settings.Following the recent discovery of an outbreak of H5N1 on a Spanish mink farm, scientists have identified that the strain of the virus behind the outbreak contains a mutation that could make the virus more adaptable to mammals. While experts have stressed that there is no need panic, the outbreak is a reminder of the importance of disease surveillance and preparedness measures, especially as a new variant of H5N1 has spread among bird populations and spilled over into humans in recent years. Scientists have not detected any transmission of this latest strain among humans, although the mutation could increase the potential risk.Fungal pathogens are a growing threat to global public health, according to experts and the World Health Organization (WHO), which published a list of priority fungal pathogens last year. Resistance is exacerbating the threat. For example, Candida auris, Aspergillus fumigatus, and Cryptococcus neoformans, which WHO ranks among the four highest priority threats, have all shown resistance to current tools. There are also no vaccines for the top four critical infections identified. As aging populations and the climate crisis contribute to growing antimicrobial resistance, there is a strong need for improving surveillance capacity and investing in developing diagnostics, medicines, and other interventions for fungal infections, which currently account for less than 1.5 percent of all infectious disease research spending, according to 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.Last week, CEPI announced a partnership with Dutch biotechnology company, 20Med, to support the development of technology that could eliminate the need for frozen storage of mRNA vaccines. The initial investment of up to US$850,000 will go toward a proof-of-concept of the company’s bio-responsive polymeric nanoparticle platform technology. If effective, the technology could help make major strides in access to mRNA vaccines, which transformed the global response to COVID-19 and have the potential to address a number of other diseases but require cold storage, which creates access challenges to these products, especially in low resource settings.A recent study in The Lancet found that an experimental vaccine against Marburg virus was safe and produced an immune response in a small, first-in-human phase 1 clinical trial. The candidate, cAd3-Marburg, was developed at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center and uses a vaccine platform called cAd3, which previously demonstrated a good safety profile in investigational vaccines developed for Ebola virus and Sudan virus by the center. Further trials of the vaccine candidate are planned in Ghana, Kenya, Uganda, and the United States, which could propel the candidate as a viable tool in the response to outbreaks of Marburg virus.2022 saw a handful of milestones in the fight against neglected tropical diseases (NTDs) with Togo becoming the first country to eliminate four of the diseases and Malawi eliminating trachoma, among other achievements. However, to address the major challenges that remain, funding for the research and development (R&D) of improved treatments and diagnostics will be crucial. New medicines to treat NTDS are urgently needed as current treatments medicines are often ineffective, intolerable, or entirely absent. While promising innovations for treatments against sleeping sickness and visceral leishmaniasis, among others, are in the pipeline, collaboration and partnerships will be necessary to catalyze further innovation and development.

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, two new studies reported promising results about the efficacy of the updated bivalent COVID-19 vaccine, which targets both the original virus and Omicron subvariants BA.4 and BA.5. A New England Journal of Medicine study found that the updated vaccine provided additional protection against severe illness, hospitalization, and death when compared to the previously used monovalent vaccine, A second study in the US Centers for Disease Control and Prevention journal Morbidity and Mortality Weekly Report found that the bivalent vaccine is similarly effective against the newer XBB and XBB.1.5 strains as it was against the earlier strains that it was designed to target.A recent outbreak of avian influenza, or H5N1 flu, on a mink farm in Spain is causing alarm after the variant behind the outbreak was found to contain a genetic change that is known to increase the ability of animal-flu viruses to jump to mammals. While there have been H5N1 infections found in various species over the past year, this outbreak is unique because mammal cases in previous outbreaks were spread by contact with virus-contaminated material. In this case, the new strain itself could have the ability to spread to and between mammals. Were the strain to start spreading between humans, authorities should have the ability to quickly produce a vaccine, and the antiviral drug Tamiflu could reduce disease severity.Moderna recently published promising results from respiratory syncytial virus (RSV) vaccine trial in older adults, echoing similarly encouraging results from four other RSV vaccine trials and last year’s approval in the European Union and United Kingdom of a long-lasting antibody treatment that protects babies against RSV. The development of a RSV vaccine has long been a challenge because the main protein on the outside of the virus has the ability to change shape as it infects cells in the body, but researchers have found various ways to address the tricky protein. The recent innovation in vaccines and antibodies for RSV has the potential to dramatically reduce illness and deaths caused by the virus each year.

Neglected tropical diseases (NTDs) are a group of infectious diseases that exert a crushing burden in vulnerable communities around the world. These diseases blind, disable, and disfigure people, robbing them of health and opportunity and trapping them in poverty. While breakthroughs in recent years have brought new resources to the fight against NTDs, significant gaps remain in the arsenal of tools needed to control and eliminate these diseases. In recognition of World NTD Day on January 30, GHTC is testing our readers’ knowledge with nine questions about NTD innovation. See if you can beat our quiz below and join the fight to #BeatNTDs and #EndTheNeglect.

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 Coalition for Epidemic Preparedness Innovations (CEPI) last week announced US$2 million in funding for American pharmaceutical company, Tiba Biotech, which has developed promising RNA technology that could make the development of mRNA vaccines targeting Disease X (a pathogen with pandemic-potential that has yet to be identified) cheaper, more effective, and more tolerable. While mRNA vaccines for COVID-19 have successfully been administered globally, limitations including side effects and ultra-cool cold chain storage requirements hinder their effectiveness and accessibility. This first round of funding will support the development of a vaccine candidate for Japanese encephalitis. If that candidate is successful, this technology could lead to the development of a variety of Disease X vaccine candidates to be included in CEPI’s library of vaccines as part of the 100-day plan to speed up vaccine development and rollout after the emergence of a disease threat.Last week, the World Health Organization’s (WHO’s) Africa Region declared the end of the recent outbreak of Sudan ebolavirus. WHO is expected to convene Ebola experts to discuss how to move forward with the plans to trial three experimental vaccine candidates that target the Sudan strain responsible for the recent outbreak. The trial was aimed at ensuring both study groups received protection from a vaccine (one group after a time delay) and generating data about the potential of these candidates, which is much needed, as there are no approved vaccines targeting Sudan ebolavirus. Finding a new strategy for testing the vaccine candidates will be challenging because the Sudan ebolavirus is rare and with limited cases, and therefore it would be difficult to obtain enough data to prove safety and efficacy, especially for all three candidates. One potential path for continuing the trial is testing efficacy on non-human primates and then more extensive testing of safety and immune response in healthy human volunteers.Last week, the Respiratory Virus & Microbiome Initiative was launched, in collaboration with the UK Health Security Agency and funded by the Wellcome Sanger Institute. The initiative will track the evolution of a variety of respiratory pathogens including SARS-CoV-to improve viral monitoring in the UK and enhance the country’s ability to quickly identify the emergence of new viruses. There is additional hope that this work will ultimately generate much-needed knowledge about the viral families behind common diseases, as well as spur the development of vaccines and therapeutics for these viruses. This initiative comes after the COVID-19 pandemic led to viral sequencing efforts around the world that helped guide responses and detect new variants and led to the development of diagnostics and vaccines.