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 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.

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) last week announced its first COVID-19 vaccine license agreement through the COVID-19 Technology Access Pool (C-TAP) with Taiwanese manufacturer Medigen Vaccine Biologics Corp. The vaccine license was acquired through the Medicines Patent Pool, which also enabled last week additional agreements under C-TAP for a COVID-19 vaccine prototype and a test used to measure COVID-19 antibody levels. While C-TAP was launched at the height of the pandemic to promote technology sharing to improve access, particularly to vaccines, in low-income countries, major pharmaceutical companies have thus far declined to join the initiative.A clinical trial led by researchers at St George’s, University of London found that a higher dose of the antibiotic rifampicin for an abbreviated four-month treatment regimen for tuberculous (TB) was safe with no increases in side effects or toxicities, compared to the standard six months, which is WHO-recommended. The trial took place among adults with newly diagnosed pulmonary tuberculosis in Uganda, Guinea, Peru, Nepal, Botswana, and Pakistan. Experts say shorter treatment regimens will help lower costs and increase patient compliance, which will in turn reduce transmission and the development of resistance to available TB drugs. CSL Sequiris announced that it received an award from the Biomedical Advanced Research and Development Authority (BARDA) to deliver a vaccine for bird flu to the US government, increasing BARDA’s stockpile in case of an outbreak. The company will deliver one bulk lot of the H5N8 A/Astrakhan antigen to the US government, whose development has been supported by BARDA in recent years. The agreement is intended to improve US national vaccine preparedness and is especially significant as bird flu continues to be detected around the world, including a small number of human cases.

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, a landmark study published in The Lancet Infectious Diseases confirmed that the benefits of combining the RTS,S malaria vaccine with preventative antimalarial drugs in settings of high seasonable malaria transmission continue over five years. Specifically, the study found that the vaccine-drug combination reduced severe malaria cases and deaths in young children by nearly two-thirds compared to either RTS,S vaccination or seasonal malaria chemoprevention alone and that the efficacy of RTS,S in preventing malaria in highly seasonal settings was similar to seasonal malaria chemoprevention. These results underscore the importance of integrating multiple prevention tools into existing malaria control efforts to alleviate the remaining burden of malaria.The US Department of Health and Human Services (HHS) announced recipients for the first $1.4 billion round of funding for Project NextGen, the successor to Operation Warp Speed, which includes awards to develop more effective and longer-lasting COVID-19 vaccines, a new monoclonal antibody, and technologies to streamline manufacturing. Regeneron, the Global Health Investment Corporation, and Johnson & Johnson Innovation are among the first group of recipients. HHS said these awards are a catalyst to kick staff research and anticipates announcing additional awards for the $5 billion program by the end of the year.  The US Food and Drug Administration (FDA) last week approved Abrysvo, Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant people, which is aimed at protecting newborns from the virus in their first six months of life. The announcement follows the agency’s approval of Abrysvo for adults 60 and older. The US Centers for Disease Control and Prevention is expected to recommend the vaccine soon, hopefully setting the country up for a healthier fall and winter season ahead with AstraZeneca and Sanofi’s Beyfortus RSV monoclonal antibody for infants also approved earlier this summer and updated COVID-19 shots expected in the coming weeks. 

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. As COVID-19 infections and hospitalizations rise across the United States, last week Moderna reported initial data that showed the efficacy of their updated COVID-19 vaccine, which was originally aimed at protecting against the XBB.1.5 subvariant, against the increasingly dominant Eris (EG.5) and Fornax (FL 1.5.1) subvariants. The updated vaccine is expected to be available in the fall, pending approvals from US Food and Drug Administration (FDA) and other national regulators. Novavax, as well as Pfizer and partner BioNTech, are also advancing updated shots.The United Kingdom’s Fleming Fund last week announced that it will provide up to $267.5 million for strengthening antimicrobial resistance (AMR) surveillance capacity in low- and middle-income countries in Africa and Asia, where the threat and burden of AMR is the highest. Specifically, the funding will go to upgrading laboratories, introducing new genome sequencing technology, and supporting training sessions. This announcement, which came ahead of this past weekend’s G20 Health Minister’s Meeting, where AMR was an important topic, marks a significant investment in a data-driven approach to fighting the rising threat of AMR.A new antibiotic combination drug that could significantly improve the treatment of complicated urinary tract infections and potentially serious infectious caused by highly resistant bacteria is now on track to receive a final review by FDA. Cefepime-taniborbactam, developed by Venatorx Pharmaceuticals and the Global Antibiotic Research & Development Partnership (GARDP), could be approved as early as next February. If successful, the treatment would be the first new treatment in GARDP’s clinical development portfolio to gain regulatory approval and would be a boon to global equitable access to new antibiotic treatments due to GARDP’s exclusive rights to distribute and sub-distribute the treatment in 64 low- and middle-income countries.