Breakthroughs Blog: Access

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, Indian drug company Cipla confirmed that a generic version of the HIV prophylaxis long-acting cabotegravir (CAB-LA) will be manufactured at its plants in South Africa for the first time, which could potentially offer millions of people at risk of HIV infection in Africa access to the groundbreaking drug. CAB-LA is a two-monthly jab that is easier to take regularly and has also been found to work better than the daily HIV prevention pill, which is currently available for free in South Africa and several other countries on the continent. The introduction of generic manufacturers into the market for HIV drugs has the potential to dramatically reduce medicine prices, which are often out of reach for low- and middle-income countries, even at prices discounted by the manufacturers that hold the original patents.IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, the only live, attenuated mycobacterium tuberculosis (TB) vaccine in the pipeline. The developers are targeting the vaccine for use in adults and adolescents and are aiming for the candidate to be more effective and potentially longer lasting than the bacillus Calmette-Guérin, or BCG, vaccine that is currently in use to prevent TB in newborns. IAVI is planning to commence a trial for the MTBVAC in 2024 after sufficient funding is secured. The deal also includes support for advancing MTBVAC for infants following Biofabri commencing a phase 3 trial of MTBVAC in neonates last year.Last week, the US National Institutes of Health announced that they are beginning to enroll patients in an early-stage clinical trial testing an mRNA universal flu vaccine that is aimed at protecting against a wide variety of strains of the flu and providing long-term immunity. The shot, designed by researchers at the National Institute of Allergy and Infectious Diseases, will test whether the shot is safe and produces an immune response in 50 healthy adult volunteers. If proved to be safe and effective, a universal flu vaccine could eliminate the need for scientists and vaccine manufacturers to predict the dominant flu strain and produce shots in advance of prime flu season, as well as reduce the risk of illness and hospitalization, particularly when the shots available are not well matched to the dominant circulating strains.

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 Thursday, the World Health Organization (WHO) declared the end of the global health emergency for mpox following a recommendation from WHO’s emergency committee on mpox, which also recommended continued management to prevent the virus from evolving. Bavarian Nordic’s vaccine for smallpox was deployed in the United States and Europe under emergency authorizations and recommended by WHO primarily for post-exposure during the mpox emergency, although the limited available stock that was already earmarked for wealthy countries created access challenges in low- and middle-income countries. Randomized control trials planned in endemic countries will provide more essential data about the efficacy of the vaccine against mpox. Additional data is also needed to fully understand how the strain of the virus evolved to sustain prolonged transmission between humans.Last week, the US$30 million Human Pangenome project, launched in 2019 and funded by the US National Human Genome Research Institute, published the first phase of the first human pangenome, which aims to be a genome that is more representative of the diversity of DNA in humans around the world. The genome could be an important guide for researchers building genetic tests and looking for new drug targets. This initiative addresses diversity gaps in the first reference genome, released in 2001, which have undermined the ability to develop tests that work across diverse populations.A new global research consortium organized by the Centres for Antimicrobial Optimisation Network aims to fight antimicrobial resistance by improving clinical use of antimicrobials and improving practices and guidelines for prescribers, users, and policymakers. Research hubs in Kampala, Cape Town, São Paulo, Liverpool, and London—where there is a high burden of drug-resistant infections and where there are communities highly affected by the burden of infectious disease—will generate essential data on the optimal use of antibiotics. Researchers hope this will in turn lead to more effective treatment and prevention of bacterial infections in the face of rising antimicrobial resistance worldwide.

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 Thursday, the World Health Organization (WHO) officially launched its mRNA vaccine technology hub in Cape Town, South Africa. During the COVID-19 pandemic, the facility was established in response to global vaccine access inequity to pursue mRNA vaccines for COVID-19 and potentially other poverty-related diseases. South African biotech firm Afrigen Biologics and vaccine producer Biovac are working with the publicly available sequence of Moderna’s mRNA COVID-19 vaccine to create a similar vaccine candidate, which will be tested on humans early next year. The candidate will the first to be made based on a widely used vaccine (like Moderna’s) without the developer’s approval and assistance and the first mRNA vaccine designed, developed, and produced at lab scale on the African continent.The White House plans to nominate cancer surgeon Dr. Monica Bertagnolli to become the director of the US National Institutes of Health (NIH), succeeding Dr. Francis Collins, who stepped down in 2021. Dr. Bertagnolli has served as the director of the National Cancer Institute since last fall. If confirmed by the Senate, she will inherit COVID-19 pandemic-era challenges around increased scrutiny of the agency’s funding of virus research, including grants to EcoHealth Alliance, which studied coronaviruses in Wuhan, China.Two studies published last week found that repurposed drug combinations lowered the risk of severe COVID-19 in high-risk patients. Stanford University researchers looked at the combination of the antidepressant fluvoxamine and the corticosteroid budesonide among nonhospitalized adults with early symptomatic COVID-19 and at least one risk factor. A second team from Weill Cornell Medicine looked at the combination of the monoclonal antibodies amubarvimab and romlusevimab in nonhospitalized adult COVID-19 patients with high-risk factors. Using combinations of repurposed drugs to treat severe COVID-19 (if successful in further testing) could prove to be an important tool in reducing the burden of COVID-19 in low- and middle-income countries, where oral therapeutics for COVID-19 are largely unavailable.

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 World Health Organization (WHO) has announced efforts to fast-track the testing of vaccines and therapeutics for Marburg following the recent outbreaks in Tanzania and Equatorial Guinea. Those trials should get underway soon, said WHO officials, as four or five of the 28 potential candidates already have doses ready. In the meantime, contact tracing, isolation, and supportive care are being used to prevent transmission in the countries. A lack of laboratory capacity in Equatorial Guinea has so far prevented the timely identification of cases, but the Africa Centres for Disease Control and Prevention is working to provide technical support, as well as build infrastructure and capacity to improve testing, which will be important in upcoming trials.Last week, the US Centers for Disease Control and Prevention (CDC) warned about the recent, rapid spread of the drug-resistant fungus Candida auris, or C. auris, in health care facilities and highlighted the serious risk the fungus poses to immunocompromised individuals. C. auris is resistant to typical antifungal treatments, and developing a vaccine for the fungus would likely take many years. There are currently no approved vaccines for any form of fungal infections. One vaccine candidate, being developed with support from the US National Institutes of Health, is designed to be cross-protective against several fungal pathogens, potentially including C. auris, although a phase 1 clinical trial is over a year away.Executives at three of the world’s leading flu vaccine manufacturers—GSK, Moderna, and CSL Sequiris— have said that they are preparing the capacity to develop hundreds of millions of avian flu shots within months if a new strain of avian flu jumps to humans. The companies are already or will soon begin testing sample human vaccines that match the subtype currently circulating among birds and mammals. Sanofi has also expressed its readiness to begin production, alongside its stock of existing H5N1 vaccines. However, there is concern about how to ensure equitable global access to such vaccines in the case of an outbreak, given a substantial portion of doses are already reserved for wealthy countries through preexisting preparedness contracts.