Breakthroughs Blog: Ebola

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.Regulators in Zimbabwe have approved long-acting injectable cabotegravir, (CAB-LA), making the country the first in Africa and the third in the world (after Australia and the United States) to approve the drug. The World Health Organization (WHO) called the approval a “crucial step” and noted that it would support the implementation and distribution of the prevention method in the country to maximize impact. WHO previously issued a recommendation for CAB-LA in July that cited its high efficacy in reducing HIV transmission among high-risk individuals.A research team from the University of Cape Town published new findings showing evidence that a cancer drug currently in clinical trials has shown potential in protecting from, curing, and preventing malaria transmission. The investigational drug, sapanisertib, acts by killing the human malaria parasite in the liver, the human host red blood cell, and when it divides sexually within the host red blood cells. This is an incredibly significant finding as the drug exhibits a novel mechanism of action as well as activity against multiple stages of the parasite life cycle. Further research could lead to the development of a critically needed novel malaria drug that contributes to malaria control and elimination efforts as well as addresses drug resistance.The United States provided Gilead Sciences’ antiviral, remdesivir, and Mapp Biopharmaceutical Inc’s experimental antibody drug, MBP134, to Uganda in an effort to help prevent further cases and deaths in the outbreak, which is now the largest outbreak of the Sudan strain of Ebola in over 20 years. Both Ugandan and US government officials noted the need for treatment to protect the lives of health care workers, which is a key step in containment.  

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 National Institute of Allergy and Infectious Diseases and the Democratic Republic of the Congo’s National Institute for Biomedical Research are co-leading a clinical trial evaluating the safety and efficacy of the antiviral drug, tecovirimat (TPOXX), in mitigating symptoms and preventing serious outcomes in 450 adults (including pregnant individuals) and children with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States. The drug impedes the spread of virus in the body by preventing virus particles from exiting human cells. Trial participants will be randomly assigned to receive the oral pill or placebos twice daily for two weeks. The World Health Organization (WHO) has announced that a clinical trial of vaccines aimed at preventing the rare Sudan strain of Ebola could start within weeks, pending regulatory approvals from the Ugandan government. There is no vaccine for the Sudan strain, which is behind the rapidly growing outbreak in Uganda. The trial will test two vaccines in development that have shown potential to treat this strain. Details about the specific vaccine candidates were not released. While the Sudan strain is less transmissible and has had a lower fatality rate in past outbreaks, compared to the Zaire strain, the Ugandan outbreak is incredibly concerning, and vaccines are urgently needed. By raising public awareness of emerging diseases and the need for laboratory capacity to address them, COVID-19 has inspired several Asian countries, including India, to invest in advanced biosafety laboratories. These labs are needed for working on dangerous pathogens and live viruses like SARS-CoV2. Some researchers have expressed concerns about the high cost of maintaining these facilities due to extensive safety measures including extra security, self-closing doors, and filtered air, among others. Concerns have also arisen about the potential risk of these labs handling extremely dangerous pathogens, however new labs could also improve overall safety practices that would reduce this risk. These new labs could play an important role in supporting more vaccine research, including for endemic infectious diseases in the region, as well as improving working conditions for researchers. 

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 a clinical trial of one or possibly two experimental vaccines designed to protect against the rare Sudan strain of the Ebola virus that has been identified in the recent, rapid outbreak in Uganda. The trial could begin within weeks depending on the Ugandan government’s permission, which is expected soon, as well as regulatory and ethics review approvals. The trial was announced by the WHO’s Health Emergencies Program, which has been conferring to identify vaccines that are far enough along in their development to undergo clinical testing. There are six vaccine candidates in development that are designed to target the Sudan strain, only half of which have advanced to the stage of human clinical trials. Of those, a candidate developed by the Sabin Vaccine Institute and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases is the furthest along in its development. Dengue resurged across Asia following a period of lower transmission due to reduced mobility because of COVID-19 restrictions, but an exciting vaccine has the potential to make huge strides in reducing the burden of the disease not only in the region but around the world. In August, Indonesia became the first country in the world to approve Takeda’s Qdenga, or TAK-003, vaccine for use against dengue in 6- to 45-year-olds. Qdenga showed incredibly promising results in clinical trials and is under review by the European Medicines Agency and other regulatory agencies in dengue-endemic countries, although it is yet to receive WHO prequalification. The vaccine addresses the complexity of dengue’s four strains by using a weakened version of the DENV 2 strain as its base and including genes from the other three strains.In 2020, a clinical trial in South Africa testing PrEP as a shot delivered every few months found incredible success with results showing high efficacy compared to the daily pill. The drug used in the trial (long-acting cabotegravir or Cab-LA) made by ViiV Healthcare has only been awarded regulatory approval in the United States to date. Access to the shot in low- and middle-income countries has been hampered by the company’s decision to not grant licenses for generic makers to produce the drug at a lower cost. The company has made an agreement with the Medicines Patent Pool that permits three or fewer companies to make generic versions of the drug in 90 low- and middle-income countries, but it could take at least three years for regulatory approval. Viiv Healthcare has submitted its drug for WHO prequalification, which could speed up this approval process. 

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 a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.