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.Clinical trials for Johnson & Johnson’s (J&J) COVID-19 vaccine candidate and Eli Lilly’s COVID-19 monoclonal antibody treatment were paused last week, while the US arm of AstraZeneca’s COVID-19 vaccine trial remains on hold since a patient’s potential adverse reaction in September. Vaccine experts say these pauses should be reassuring, not frightening, as they indicate the trial process is functioning as it is designed to; a clinical trial with no reports of adverse events would be unusual. J&J announced its trial pause after an “unexplained illness” in a trial participant, and the company will be reviewing the case along with an independent data monitoring board before making a decision on whether to resume the trial. Eli Lilly’s trial pause came after a potential safety concern flagged by an independent review board, and the board will review the data again at a later date to make a decision on its continuation.Pfizer announced last week it has received approval from the US Food and Drug Administration (FDA) to expand its COVID-19 vaccine trial to include children ages 12 and up. This development will look to understand vaccine safety and efficacy among adolescents and will mark the first inclusion of children under 16 in a COVID-19 vaccine trial in the United States. More than half a million children have been infected with COVID-19 this year, and more than two-thirds of the children who died were Black or Latinx, according to Sara Gozer, president of the American Academy of Pediatricians. While vaccine trials began with a focus on older participants due to their higher risk for more serious illness, pediatricians have emphasized the importance of not leaving children behind as trials progress.FDA has approved Inmazeb, an antibody cocktail made by Regeneron, for use as an Ebola therapeutic. This is the first FDA approval for a treatment specific to Ebola, and means there is now an FDA-approved treatment and vaccine for the virus. The treatment, which has been used during the current Ebola outbreak in the Democratic Republic of the Congo (DRC) under compassionate use protocol, was shown to be effective during a clinical trial conducted during the 2018–2020 outbreak in eastern DRC. The Biomedical Advanced Research and Development Authority has purchased an undisclosed number of Inmazeb doses for the US strategic stockpile, and Regeneron has said it will work to ensure low-income countries will also have access to the treatment.

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.  Five African countries have become the first to license Merck’s highly effective Ebola vaccine, rVSV-ZEBOV-GP. This means the vaccine can now be administered in those countries—including the Democratic Republic of the Congo (DRC), Burundi, Ghana, Zambia, and Guinea— without being subject to clinical trial or research protocols. Three months ago, the World Health Organization (WHO) prequalified rVSV-ZEBOV-GP when it announced that the vaccine met quality, safety, and efficiency standards—paving the way for African countries to start their own regulatory processes. rVSV-ZEBOV-GP was first used in the 2015 Ebola outbreak and later in the current ongoing outbreak under a “compassionate use” research protocol, where it was found to be more than 97 percent effective. Last week, Sanofi Pasteur announced it would partner with the US Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine for the novel coronavirus, COVID-19. Sanofi’s previous work to develop a vaccine for SARS, another coronavirus, could give the company a head start on other drug-makers racing to develop a vaccine against COVID-19. With BARDA funding, Sanofi plans to develop a bank of vaccine candidates and produce pilot lots for testing. No decisions have been made about later-stage funding. Sanofi expects to have a vaccine candidate to test in the lab within six months, which could be ready for human trials within a year to 18 months. Sanofi is the second major vaccine maker, along with Janssen (Johnson & Johnson), to announce it will try to develop a vaccine against COVID-19, which has reportedly infected more than 70,000 people, mostly in China. Other small biotechs are also working on candidates. The Zambia National Public Health Institute and FIND have launched a new platform that enables data-driven decision-making to tackle antimicrobial resistance (AMR). The platform, Zambia One Health Surveillance System, captures reliable AMR data from across sectors, including human and animal health, in a unified and harmonized data management system. Prior to this platform, Zambia lacked a systematic approach for the collection, collation, and analysis of AMR data to inform an effective response to the rising threat of AMR. According to WHO, AMR is a global public threat that could lead to over ten million deaths per year by 2050.

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.