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.  The second-largest Ebola outbreak in history—which has infected 3,500 people and killed 2,250 in the Democratic Republic of Congo (DRC) since August 2018—is down to its last chain of transmission despite ongoing violence that has hampered response efforts. The waning of the Ebola outbreak comes as the outbreak of the novel coronavirus, COVID-19, has captured global attention and potentially funding as well. According to a World Health Organization (WHO) spokeswoman, “Funding needs [for the Ebola response] have not as yet been fully met, and currently there is a risk there will not be funding for WHO activities beyond February.” Despite the waning of Ebola cases in DRC, last Wednesday, an independent committee that advises WHO unanimously agreed the Ebola outbreak continues to be a public health emergency—a designation recently extended to the COVID-19 outbreak. Though WHO and others have worked tirelessly to contain Ebola, the region’s health system remains weak and the likelihood of future outbreaks is high. The experimental antiviral drug remdesivir successfully prevented disease in rhesus macaques infected with Middle East respiratory syndrome coronavirus (MERS-CoV), according to a study performed by the US National Institutes of Health and supported by the Biomedical Advanced Research and Development Authority. Remdesivir both prevented disease when administered before infection and improved the condition of the macaques when given after the animals already were infected. MERS-CoV is closely related to COVID-19, which emerged in Wuhan, China in December of last year and has grown to be a public health emergency. The promising results of this study support the case for additional clinical trials of remdesivir for MERS-CoV and COVID-19. Gilead Sciences developed remdesivir and collaborated in the research. On Monday, February 10, President Trump released his proposed budget for fiscal year 2021, which seeks deep cuts of US$3 billion to global health funding. The proposed cuts include a 34 percent reduction to global health programs at the State Department and US Agency for International Development (USAID) and a seven percent cut in funding to the Centers for Disease Control and Prevention (CDC)’s Center for Global Health. President Trump’s budget also proposed a 58 percent reduction in funding to the Global Fund to Fight AIDS, Tuberculosis and Malaria and a 50 percent cut in funding to WHO. Despite these widespread proposed cuts, the budget did include some boosts in funding—a $50 million increase for CDC’s global health security activities and $15 million for USAID’s Global Health Security programs. President Trump’s budget has been condemned by public health experts and many lawmakers, who have spoken out against the cuts which are unlikely to go into effect.

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 approved an Ebola vaccine developed by Merck, making it the first Ebola vaccine to be approved in the United States. Merck’s vaccine, Ervebo, protects against the Zaire strain of the virus, which has been the most common cause of Ebola outbreaks and is responsible for the current outbreak in the Democratic Republic of the Congo (DRC). The decision by FDA to approve Ervebo follows the European Commission’s decision to license the vaccine last month. In securing approval by FDA, Merck also qualifies for a tropical disease priority review voucher. Merck announced it has also submitted Ervebo for approval to regulatory authorities in a number of African countries at risk of having Ebola outbreaks. The vaccine has also been prequalified by the World Health Organization, which could speed up regulatory approval in African countries.Scientists at the Massachusetts Institute of Technology have developed a microneedle patch that, when applied to a person’s skin, can simultaneously deliver a vaccine and embed a record of the vaccine using a pattern of fluorescent nanocrystals. The vaccine record, written in quantum dots that emit near-infrared light that is invisible to the naked eye but readable by a modified smartphone, does not require a link to a database and is not tied to any personal information. This device could help fill a gap in medical record keeping, especially in developing countries where resources to properly document immunizations may be lacking. Still in the prototype stage, the technology has been tested in the skin of human cadavers exposed to a simulated five years of sunlight, and its efficacy at delivering polio vaccine has been confirmed in rats. Further feasibility and human trials will be needed.Researchers at the University of Queensland and QIMR Berghofer Medical Research Institute have discovered that a virus can be “masqueraded” to resemble other viruses to help develop new, more effective vaccines against mosquito-borne diseases. The Binjari virus, which affects mosquitoes but is harmless to humans, can have its surface manipulated, so that it resembles other viruses. When these “chimera” Binjari virus cells are then used in vaccines, they prompt an immune response for the virus they are imitating without causing harm from that virus. This chimera virus is also much safer to work with compared to live viruses, which risk breaking biocontainment protocols during research and vaccine production. Researchers also noted that the Binjari virus is easy to re-dress, meaning scientists could quickly develop chimera viruses, reducing the time it takes to respond to an outbreak. Developing safe and effective vaccines for mosquito-borne viruses would be a major scientific breakthrough as vaccine coverage for this disease group is currently very limited.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dan Littlefield, who we met at the American Society of Tropical Medicine and Hygiene Annual Conference. Dan co-founded a cold-chain engineering company that worked with the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority to distribute Ebola vaccines for clinical trials in Sierra Leone.My name: Dan Littlefield, MSWhere I work: Modality Solutions LLC I’m funded by: US Centers for Disease Control and Prevention (CDC), Biomedical Advanced Research and Development Authority (BARDA)My research: I’m a principal and one of the founding members of Modality Solutions. We’re a cold-chain engineering company that’s headquartered in League City, Texas, just outside of Houston. We do a lot of work with pharmaceutical and biotech companies to ensure their product, when it gets to the patient, is just as good as when it left manufacturing.Back in 2015, we were contacted by a contractor for the US government because there was a critical need in West Africa to support getting vaccines there as part of a phase III clinical trial that the CDC and BARDA were sponsoring in Sierra Leone for an Ebola vaccine. Motivation: We’re a growing company, we recruit a lot of young engineers, and when I talk to engineers, I find that we all love to do engineering work, but we also all like the direct impact of helping people. And one of the great things about the work we’re doing, especially with the emergency response clinical trials, is that there is a direct tie between the work we’re doing and how we’re saving lives.Why US federal support is critical: First, this is a national security issue because diseases like Ebola are dangerous. They’re dangerous to civilian populations in West Africa and potentially dangerous to US populations as well. And I think there’s an important diplomatic aspect to it. A lot of these countries are allies to the United States, and one of the ways to lift them up and improve living conditions in those countries is to go and do this kind of work. It also provides a stabilizing influence and improves local capabilities as well. That’s one of the things we try to focus on: it’s not about going in and doing the work and leaving, it’s about going in and training the local staff because a lot of very smart pharmacists and medical doctors don’t have a lot of experience dealing with heat transfer and thermal packaging and managing temperature-sensitive pharmaceuticals. If we can go in and transfer that knowledge, it really enhances them and helps them for the future, not just for clinical trials, but even just for standard vaccine strategies and drug treatments.When I’m not in the lab: My hobby is that I work as a reserve patrol sergeant with the Galveston Sherriff’s office. Galveston County is a big county just south of Houston. I work uniform patrol there, and I’m a weapons and tactics instructor for the department—so that fills up the rest of my time.

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.  British drug maker GlaxoSmithKline (GSK) applied for a license to market its HIV drug, dolutegravir, in a child-friendly formulation that, if approved by regulators, will become the first new generation HIV medicine available in a child-friendly form. Developed by GSK’s HIV drug division ViiV Healthcare, this new formulation of dolutegravir is designed to be easier for babies and children to swallow. Because there is no licensed version of dolutegravir for children, doctors often prescribe older HIV medicines that can be less potent, harder to take, and have more side effects. GSK plans an initial rollout of the child-friendly formulation at “cost of production” early next year, pending licensure by US and European regulators, and is also planning licensing agreements with two generic drug makers who aim to make cheaper versions of the medicine available within months of the initial rollout. According to UNAIDS, approximately 1.7 million children are living with HIV, most of them in sub-Saharan Africa. According to reports released by Treatment Action Group (TAG) and the Stop TB Partnership, global funding for tuberculosis (TB) research and development (R&D) has reached an all-time high, though funding targets for efforts to eliminate the disease remain far from being met. According to the TAG report, TB R&D funding reached its highest level in 2018 at US$916 million, representing three consecutive years of funding increases. However, the Stop TB Partnership’s updated Global Plan to End TB—which aligns with the commitments made at the United Nations High-Level Meeting on TB in September 2018—calls for $2.6 billion per year for R&D for new diagnostics, drugs, and vaccines, in addition to the $13 billion needed for TB prevention and care. The Stop TB Partnership notes that reaching these funding goals would help provide care for 40 million people living with TB, enable 30 million to get preventive treatment, and put new diagnostics and treatment tools within reach by 2030. A new program approved by the board of Gavi, the Vaccine Alliance (Gavi), will fund a global emergency stockpile of Ebola vaccines that will be open for use by those in need of outbreak and prevention efforts. The program will be funded for $178 million through 2025 and will focus on low- and middle-income countries who will have access to the stockpile free of charge and will also receive support for the operational costs of vaccination campaigns. The World Health Organization’s SAGE Working Group on Ebola Vaccines and Vaccinations state that the stockpile should maintain 500,000 licensed doses of vaccines. In addition to the Ebola vaccine stockpile, Gavi will allocate another $1.6 million in funding for the RTS,S malaria vaccine implementation program from 2021-2023, which is ongoing in three African nations, which will evaluate the vaccine’s effectiveness in reducing childhood deaths when used in real word settings.