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. On Friday, the US Department of Health and Human Services announced another $500 million in Project NextGen funding, which will support phase 2b clinical trials of three COVID-19 vaccine candidates, as well as other technologies to enhance preparedness against COVID-19 and future disease outbreaks. Specifically, the awards will go to two intranasal vaccine candidates that are administered as sprays and one self-amplifying mRNA vaccine candidate that is administered as an injection; phase 2b clinical trials of those vaccine candidates could start as soon as this winter. Funding will also go to the development of vaccine patches, cold-chain sample management, genomic sequencing, and increased laboratory capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) is leading an initiative with the biopharma data provider IQVIA aimed at enhancing global research capacity to advance the 100 Days Mission, which aims to be able to respond to the next Disease X (a future pathogen with pandemic potential) with medical countermeasures within 100 days of its identification. Under the initiative, IQVIA will provide tools and resources to support research preparedness in underserved regions during ‘peacetime’ (when there is no ongoing pandemic outbreak) and to support clinical trials during future outbreaks of diseases with pandemic potential. CEPI will fill in gaps to ensure high-quality data are generated during an outbreak response to inform further research.Last week, The Lancet and the Coalition for Preventing Pandemics at the Source announced that they have convened the Commission on Prevention of Viral Spillover, which will work to mobilize decision-makers to support research and policies to prevent future viral spillovers and pandemics following the COVID-19 pandemic, which was the fifth viral pandemic caused by a viral spillover in the last century. The commission, which includes 28 experts in a variety of fields from epidemiology to veterinary medicine to food systems management, will conduct original research and publish a comprehensive report within two to three years on recommendations to prevent such spillovers.

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 Wednesday, Moderna announced that its combination COVID-19 and flu shot, mRNA-1083, demonstrated strong immunogenicity in a phase 1/2 trial. The trial found that mRNA-1083 was similarly effective to two already approved flu vaccines developed by GSK and Sanofi and Moderna’s own SpikeVax COVID-19 vaccine. There were also no new safety concerns reported with the combination vaccine compared to each of the vaccines used alone. A phase 3 trial testing the combination shot will begin before the end of the year with potential regulatory approval in 2025 if successful. The company also laid out its broader efforts on combination vaccines, including a combination shot for COVID-19, flu, and respiratory syncytial virus.The Biomedical Advanced Research and Development Authority (BARDA) has awarded Vir Biotechnology $50 million in Project NextGen funds to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions for COVID-19 and future pandemic threats.  The new funding will support development of alternative mAb delivery technologies that increase antibody expression relative to existing solutions, which could revolutionize mAb delivery by expanding administration options and shortening development and manufacturing timelines. Four-fifth of the funding will specifically go toward advancing Vir’s next-generation COVID-19 mAb, Vir-7229, through a phase 1 trial, expected to be completed in late 2025, while the remainder will support the discovery of new mAbs against a second pathogen of pandemic potential.The World Health Organization (WHO) last week recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford. This follows two years after WHO recommended RTS,S, the first malaria vaccine. Both vaccines have a similar efficacy profile and delivery method and are targeted to children, but doses of R21 are expected to be cheaper—between $2.00 and $4.00 compared to about $7.25 now charged for RTS,S. The Serum Institute, which will produce R21, has also announced plans to deliver a much higher volume of doses compared to GSK’s current marketing plans for RTS,S. Although it will take more time to collect further safety monitoring data for R21, the recommendation of a second vaccine will hopefully help to ensure adequate supply for malaria-endemic countries that are planning to integrate a vaccine into their national malaria control plans.

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 latest funding from the Biomedical Advanced Research and Development Authority’s (BARDA’s) Project NextGen will go to Gritstone bio for a large-scale phase 2b study of its mRNA COVID-19 vaccine candidate. $433 million will go toward the trial, expected to start early next year, which will test the company’s vaccine against an already approved one. Gritstone’s candidate aims to provide broader and longer-lasting clinical protection than first-generation COVID-19 vaccines by inducing multiple types of immunity against current and future variants of the virus that causes COVID-19.Two recent studies reviewing the efficacy and safety of higher dose regimens of the antimalarial drug primaquine bolster support for increasing doses in malaria-endemic countries. Primaquine has been used against Plasmodium vivax malaria for more than 60 years, but this new research provides the answer to a problem designated by the World Health Organization as a key research priority: how to reduce malaria relapse. The studies found that doubling the currently used dose of primaquine halved malaria relapses, while delivering a similar safety profile to the lower dose regimen, suggesting widespread implementation of higher dosing could have a significant impact on reducing P. vivax malaria relapses, deaths, and transmission in endemic countries.New research into an innovative injected hydrogel drug method for treating HIV offers hope of a completely novel management method that could drastically reduce the frequency of treatment and eliminate the need for daily pills, greatly improving the quality of life of people living with HIV. The researchers found that one injection of the gel in mice was enough to maintain effective and lasting concentrations of the drug lamivudine for 42 days with nearly no side effects by ensuring the drug was released slowly and consistently in the body. Further tests will look at the hydrogel used in combination with others drugs to prevent HIV as well as simultaneously address HIV and hepatitis B.

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 National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics two Small Business Innovative Research grants, totaling $5.7 million, for the development and testing of immunoassays for Lyme disease and Chagas disease. The company’s Lyme disease immunoassay could simplify diagnosis by eliminating the need to perform one of the two steps now used in the screening and confirmatory testing process. Kephera’s immunoassay for Chagas disease is designed to monitor treatment response in patients, as current drugs vary in efficacy in adults with chronic infections. It is being developed both for laboratory use and use in the field.A phase 1 trial evaluating a novel preventive HIV vaccine candidate, VIR-1388, has begun enrollment in the United States and South Africa. VIR-1388 is designed to prompt the immune system to produce T cells that can recognize and signal an immune response to prevent the virus from establishing chronic infection. It delivers vaccine material using a cytomegalovirus (CMV) vector, whose discovery and development was funded by the National Institute of Allergy and Infectious Disease (NIAID). Because CMV, while harmless, remains detectable in the body for life, researchers hope this vector will help the body retain the vaccine material for a longer period of time, overcoming the waning immunity seen with other candidate vaccines. The trial is sponsored by Vir Biotechnology with support from NIAID and the Bill & Melinda Gates Foundation.Last week saw the launch of a third phase 1 clinical trial of the ChAdOx1 vaccine candidate for Middle East Respiratory Syndrome (MERS). If eventually approved, the vaccine would be a game-changing tool against the viral illness, for which there are no approved vaccines or treatments, and which is recognized by the World Health Organization as a priority pathogen with epidemic potential, especially in light of new cases reported this year. The University of Oxford’s Pandemic Sciences Institute started developing the vaccine for MERS before the COVID-19 pandemic, and the research for ChAdOx1, which was put on pause during the pandemic, enabled the rapid development of the Oxford/AstraZeneca vaccine for COVID-19.

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 study published last week found that a subset of cells in dormant HIV reservoirs spontaneously produce HIV RNA and proteins, prompting the need for further research into the consequences for the immune system of these ongoing viral interactions in people living with HIV and receiving treatment. This research suggests that the RNA and proteins produced by the reservoirs could be behind inflammation, accelerated cardiac disease, frailty, and premature osteoporosis, which can persist in people who are otherwise successfully treated for HIV. Future studies will need to examine these reservoirs in more diverse populations, but this research could lead to the identification of new ways to target these remaining active viruses in people receiving HIV treatment to ensure that the virus does not rebound and to address their potential health consequences.New research has identified the spread of new strains of malaria parasites in Ethiopia that are resistant to current artemisinin-based treatments and indetectable by common diagnostic tests. This discovery follows the recent identification of strains in other regions of Africa that were resistant to either treatment or testing, although the Ethiopia strain is the first identified resistant to both. The spread of these strains could be a major challenge to efforts to eliminate malaria globally. This most recent finding also underscores the urgent need for both close monitoring of the spread of resistance among malaria parasites, as well as development of new therapies and vaccines.Last week, GARDP announced a sublicense agreement with the Indian company Orchid Pharma to manufacture Shionogi’s antibiotic cefiderocol, enabling Orchid to produce the drug more cheaply for low- and middle-income countries in the face of global gaps in access to antibiotics and rising rates of antimicrobial resistance. This agreement builds on a partnership between GARDP, Shionogi, and the Clinton Health Initiative, which granted GARDP the license last year. Cefiderocol is on the World Health Organization’s Model List of Essential Medicines and is considered globally to be an important weapon against difficult-to-treat, multidrug-resistant infections, but it has not yet been made commercially available in the majority of low- and middle-income countries.

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) has given 510(k) clearance to the BD Respiratory Viral Panel, an automated, multiplexed, and real-time PCR test that can be used to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) from only one sample, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA). The panel runs on a BD system widely used by hospitals and labs across the United States that can process hundreds of samples a day and deliver results in two hours. By reducing the need for multiple tests to distinguish the cause of respiratory infections, the test will help patients receive appropriate care faster and reduce burdens on the health system, which is important as the United States faces the rising threat of these viruses over the coming months.FDA is expected shortly to approve updated versions of the COVID-19 boosters, which although originally designed to target the XBB.1.5. omicron subvariant should still protect against the currently circulating subvariants, as cases and hospitalizations linked to the new variants rise. While it remains unclear whether the agency will grant emergency use authorizations or full approval licenses, either will trigger the Centers for Disease Control and Prevention to make its recommendations for who should receive the shots, allowing vaccinations to likely begin soon in the United States.Ghana recently became the first country in Africa to manufacture a cholera vaccine. The private-sector pharmaceutical consortium DEK Vaccines Limited produced the vaccine, as well as six others, including against malaria, HPV, pneumonia, and rotavirus, which are expected to be available by 2026. This was made possible through a licensing and technology transfer agreement with the International Vaccine Institute (IVI). Scaling up local production of vaccines is seen as an important step toward enabling Ghana, the West African region, and the continent at large to reduce the critical shortage of vaccines and reliance on foreign countries and companies and to ensure greater access to vaccines that protect against endemic diseases.