Ansley Kahn

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 new all-oral drug combination of bedaquiline, pretomanid, and linezolid cures 90 percent of people with deadly drug-resistant tuberculosis (TB) if given for six months, according to clinical trial results reported in the New England Journal of Medicine (NEJM).Typically, this high of a success rate is only seen when TB responds to conventional therapy. When TB is resistant, the success rate falls to well below 50 percent and averages just 14 percent in South Africa, where the trial was conducted by TB Alliance. Current therapy for drug-resistant TB requires taking up to seven drugs, which cause many side effects, for at least 18 months. The new regimen takes just six months, has fewer side effects, and is less costly. TB kills an estimated 1.5 million people annually and of the 10 million new cases each year, roughly 500,000 are drug resistant. The Bill and Melinda Gates Foundation have paid for 15,000 drug molecules to be shipped to the Rega Institute for Medical Research, outside of Brussels, to be tested as a potential cure to the novel coronavirus. The samples are all active ingredients in current antiviral treatments which will be rapidly screened to determine whether they have an inhibiting effect on a sample from the first Belgian patient to be diagnosed. They expect to complete the screening in a week or two. The Gates Foundation has said it will provide up to US$100 million to improve detection, isolation, and treatment efforts in response to the coronavirus outbreak. Though there are currently no proven treatments for coronavirus, a few drug trials are already underway. As of last Wednesday, more than 93,000 people had been infected in more than 80 countries and the global death toll was 3,190. Results from two phase 3 clinical trials reported in the NEJM suggest that a monthly shot of the antiretroviral (ART) drugs cabotegravir and rilpivirine work just as well as daily pills to suppress the viral load of HIV in the bloodstream. ART therapy can effectively halt the replication of the virus and nearly eliminate it from the bloodstream, prolonging life expectancy. If approved by regulators, this long-acting combination therapy could be a more convenient treatment for people living with HIV than the conventional treatment regimen of two or more pills per day, which experts say can pose adherence challenges for many. There is currently no cure for HIV, the virus that causes AIDS.

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 Thursday, the World Health Organization (WHO) launched the first digital version of its latest Model list of Essential Medicines (EML), which provides countries with guidance on the most crucial medicines to have in supply. The EML list has been revised every two years by a group of WHO experts since 1977 but has previously only been published in print or PDF format. The new electronic format makes the EML list more accessible and easily searchable, as users can filter results and export customized lists to Microsoft Excel or Word. More than 150 countries currently use the EML list to determine which medicines best meet their national health needs to compile their own national essential medicines list. US biotech firm Moderna has shipped its first batch of an experimental coronavirus vaccine to US government researchers at the National Institute of Allergy and Infectious Diseases for initial trials that could begin as soon as April. The experimental vaccine candidate will be used in a phase 1 study in the United States, which will test two doses of the vaccine on 45 healthy people. Even if this initial clinical trial is successful, further testing and regulatory approvals would be required before the vaccine could be deployed for widespread use—a process that could take at least one year or 18 months. Moderna is among a slew of companies around the world rapidly trying to identify treatments or develop vaccines against the novel coronavirus that emerged in Wuhan, China late last year, which has infected more than 80,000 people worldwide. The first clinical trial in the United States of a potential treatment for the novel coronavirus is now underway at the University of Nebraska Medical Center. In a draft research plan published last month, WHO said this antiviral medicine remdesivir was considered “the most promising candidate” to treat the novel coronavirus, citing laboratory studies suggesting it might be able to target Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS)—cousins of the novel coronavirus. Remdesivir, which is made by Gilead Sciences, is part of a study already underway in China to test its efficacy against the novel coronavirus and was previously tested in some Ebola patients in the Democratic Republic of Congo before the study was stopped. Currently, there are no proven treatments or vaccines for the novel coronavirus.

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.  A vaccine candidate for gestational malaria, known as PRIMVAC, has yielded promising results in a small clinical trial evaluating its safety and effectiveness. PRIMVAC was shown to be well-tolerated and to elicit an immune response in 100 percent of the 68 non-pregnant women vaccinated after only two injections and for up to 15 months after the initial vaccination. Malaria is particularly dangerous to pregnant women because the red blood cells infected with the Plasmodium falciparum parasite that causes malaria accumulate in the placenta, promoting anemia and gestational hypertension. Gestational malaria is also linked to a higher risk of spontaneous abortion, premature birth, and intrauterine growth delays leading to low birth weight and a high rate of neonatal mortality. Future clinical trials will focus on studying the immune response elicited by PRIMVAC longer term. Last Tuesday, the US Food and Drug Administration (FDA) issued an emergency use authorization of a diagnostic test for the novel coronavirus (2019-nCoV) that has emerged in China, sickening more than 20,000 people and killing 427 globally. This exemption will make the test—developed by the Centers for Disease Control and Prevention (CDC)—available to public health labs across the United States and around the world in an effort to contain the disease’s spread. CDC has already shipped the test to a repository where states and international partners can order it. The nonprofit Foundation for Innovative New Diagnostics (FIND)—which works to expand diagnostic capacity in low-resource countries—is now using viral isolates of 2019-nCoV to evaluate the CDC’s diagnostic test and others like it. Scientists at the Walter Reed Army Institute of Research (WRAIR) have shown for the first time that a single dose of an experimental Zika vaccine, ZPIV, in individuals previously infected by dengue can boost pre-existing immunity and elicit antibody responses against both Zika and dengue. This result was compared to trial volunteers with no prior exposure to dengue who required two vaccinations of ZPIV to reach a similar magnitude of Zika antibody responses. These findings indicate that an effective Zika vaccine could boost dengue virus immunity and generate Zika antibodies that have the potential to be a prevention tool in regions where both diseases are endemic. In three phase 1 human clinical trials the ZPIV vaccine, developed by WRAIR, has shown to be safe and well-tolerated in healthy adults and to induce a robust immune response.

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 broad study of a promising HIV vaccine has ended in failure after an interim analysis showed it was no more effective than placebo in preventing infection. Vaccinations for the Uhambo study in South Africa were halted following the determination on January 23 that 129 people who received the vaccine developed HIV while 123 people who were given placebo also contracted the infection. The trial began in 2016 following testing of a modified version of a vaccine that had proven to be modestly effective in a trial in Thailand four years earlier, thus warranting further study. The Uhambo study was only the seventh large-scale human trial of a vaccine for HIV, a virus that infected 1.7 million people worldwide in 2018, according to the Joint United Nations Program on HIV and AIDS. Two other large human trials of another HIV vaccine candidate, designed by Janssen Pharmaceuticals, part of the health care giant Johnson & Johnson, are currently underway. Funding to develop new technologies for some of the world’s leading infectious disease killers, such as HIV and AIDS, tuberculosis, and malaria, reached a record high of US$4 billion in 2018 with strong increases from the private sector, according to the 2019 G-FINDER report. This marks both the largest real annual funding increase on record and the first time that funding has grown for three consecutive years. However, investments in research and development (R&D) for neglected tropical diseases (NTDs)—a subset of debilitating but lesser-known parasitic, viral, and bacterial infections—have plateaued in the past two years and even declined by $34 million over the last decade, according to the report, which was released on the first World NTD Day. The G-FINDER report provides a comprehensive annual look at investments in neglected disease R&D, including how investments are allocated across diseases and product types, funding trends over time, and potential gaps in funding. People showing no symptoms of the novel coronavirus appear to be able to spread it, according to a report in the New England Journal of Medicine. If this finding is confirmed, it will make it much harder to contain the coronavirus, which has caused an outbreak in China and has led the World Health Organization to declare a global health emergency. Some viruses can only be passed when a person is exhibiting symptoms, while others can be spread a day or two before the onset of symptoms—meaning people who are contagious but are asymptomatic can unknowingly spread the virus, complicating containment efforts. According to the report, a woman from Shanghai flew to Germany where she appeared to have passed on the virus to a German colleague a day or two before being symptomatic herself. As of Thursday, the coronavirus was reported to have infected nearly 9,700 people in China, killing 213. Approximately 100 more infections but no deaths have been reported in 18 other countries.