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, 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.The US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.

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. In June, South Sudan is expecting to begin the rollout of the preventive malaria intervention seasonal malaria chemoprevention (SMC), although there are concerns that high parasite resistance in eastern and southern African countries will limit its long-term efficacy. In June 2022, the World Health Organization (WHO) updated its recommendations that previously restricted SMC’s use to the Sahel region, where malaria transmission is highly seasonal, to encourage its use in other regions after pilot studies showed positive results in countries with high resistance, including South Sudan. Experts have emphasized the need for rigorous monitoring and evaluation to assess SMC’s efficacy in areas of high resistance and to detect any parasite resistance in the Sahel, as well as the development of alternative tools and drugs for malaria chemoprevention.Last week, the European Medicines Agency recommended authorization of GSK’s Arezvy vaccine for respiratory syncytial virus (RSV) in adults 60 years of age and older, which if approved, will be the world’s first available vaccine for RSV. Regulatory agencies in the United Kingdom and United States are expected to make decisions on GSK’s vaccine in the coming months. Pfizer and Moderna are also developing vaccines for the virus, with Pfizer’s candidate already having gained the backing of a panel of US Food and Drug Administration (FDA) advisors earlier this year.Bavarian Nordic, the maker of the Jynneos vaccine, which is approved by the FDA to protect against both smallpox and mpox, is planning to dramatically scale up production capacity for their vaccine. The company’s CEO connected the move to the rapid spread of mpox last year, which highlighted the need to be able to manufacture at a much greater scale than currently available: from tens of millions to hundreds of millions of doses. Bavarian Nordic plans to simplify its production process to facilitate partnerships with other manufacturers in order to have adequate production capacity for stockpiling and in case of a future emergency.

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.Last week, Ghana became the first country to approve a new malaria vaccine developed by the University of Oxford’s Jenner Institute. The vaccine, R21, is the second-ever vaccine for malaria authorized for use by regulators. Ghana’s Food and Drugs Authority approved the shot for use in children between 5 and 36 months old based on final data from an ongoing phase 3 trial in almost 5,000 children. The results have yet to be published but were shared with regulatory agencies. The vaccine could become an important tool in the fight against malaria and in reducing child mortality, especially if Ghana’s approval is echoed in other countries and by the World Health Organization. The COVID-19 pandemic revealed the consequences of limited genome sequencing capabilities on the African continent and has pushed national laboratories to ramp up their ability in preparation for future pandemics. Thirty-nine African countries now have the equipment and skilled workforce for sequencing, as part of a continent-wide network with specialized training centers and regional hubs. However, capacity levels across laboratories vary, and there is a need to move beyond sequencing the virus that causes COVID-19 to broader applications and for increased training in data analysis.The Biden administration last week announced the launch of Project Next Gen, the US$5 billion-plus program that succeeds the President Trump-era Operation Warp Speed to accelerate the development of new coronavirus vaccines and treatments to address COVID-19 and future coronavirus threats. The program will primarily focus on three objectives: creating long-lasting monoclonal antibodies, advancing vaccines that produce mucosal immunity, and developing pan-coronavirus vaccines. Administration officials expressed their hope that the program can generate strong next-generation vaccines and treatments, delivering breakthroughs that could also potentially benefit other health R&D areas as well