Breakthroughs Blog: Antimicrobial resistance

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.  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.  GlaxoSmithKline has licensed a promising tuberculosis (TB) vaccine candidate to the Bill & Melinda Gates Medical Research Institute in an effort to advance this vaccine for use in low- and middle-income countries. The institute will lead further development of the vaccine candidate and sponsor future clinical tests. The vaccine candidate, developed in collaboration with IAVI, was shown in mid-stage testing to be effective in approximately half of the people who were vaccinated for as long as three years. The only licensed TB vaccine that currently exists—called Bacillus Calmette-Guerin—prevents severe disease in infants and young children but gives limited protection to adolescents and adults. TB infects about 10 million people annually, killing about 1.5 million.A new research group at the National Institutes for Health (NIH) tasked with conducting human trials for vaccines against emerging health threats will be testing the first of likely many experimental vaccine candidates against the novel coronavirus that emerged in Wuhan China late last year. They hope to have a vaccine ready to test in just three months’ time. Chinese scientists quickly identified the genetic sequence and posted it publicly, allowing scientists to begin vaccine development without waiting for a sample of the virus. NIH scientists are now working with US biotech Moderna Inc. to develop an RNA-based vaccine, while additional candidates are in development by other funders and companies. According to Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, three months from gene sequence to initial human testing would be the fastest the agency has ever gotten such a vaccine off the ground. As of Friday, Reuters reports more than 800 people in China have been infected with the new coronavirus and 26 have been killed. Cases have also been confirmed in Thailand, Vietnam, Singapore, Japan, South Korea, Taiwan, Nepal, and the United States.According to a report by the Access to Medicine Foundation, the world is “precariously reliant” on a small number of pharmaceutical companies to develop new antibiotics, running the risk of a rise in superbugs. The biennial Antibiotic Resistance Benchmark report, which looks at pharmaceutical companies’ efforts to tackle antimicrobial resistance, found that only a core group of eight drug firms are developing antibiotics and that the pipeline of new products is very small. This report echoes a warning from the World Health Organization last week that a lack of private investment and innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections. Drug-resistant infections are predicted to kill 10 million people annually by 2050 if drug resistance continues to grow at its current rate—meaning that, increasingly, the treatments we rely on to kill infections are not working, and new ones are needed.

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.  According to a report by the AMR Industry Alliance, a private sector coalition, there is a “concerning shortfall” in investment in late-stage research and development (R&D) to battle antimicrobial resistance (AMR). Though in 2018 the Alliance’s members invested US$1.6 billion in R&D for antibiotics, vaccines, and disease diagnostics needed to tackle AMR,—a figure which dropped by one-third between 2016 and 2018—the report cited this investment as likely insufficient to deliver the tools needed to address growing AMR. It also cited a lack of access to quality and responsibly manufactured antibiotics as a significant challenge in low- and middle-income countries. The report calls on the public sector to provide greater R&D investment, particularly for later-stage research, and advance policy solutions like incentives to spur greater R&D investment and improve access. According to the United Nations, AMR is estimated to result in 700,000 deaths annually, a figure that is forecast to increase to 10 million by 2050. German researchers have developed the first diagnostic test for a new coronavirus that has emerged in central China. The virus was first detected in the city of Wuhan last year and has since sickened dozens of people with recent cases reported in Japan and Thailand. The diagnostic test developed at the Institute for Virology at Berlin’s Charite hospital will allow labs to reliably diagnose the new coronavirus “in a very short period of time,” according to its developers. The test protocol is being made available by the World Health Organization (WHO), and laboratories will be able to order a molecule from the German team to compare patient samples with a positive control. Until now, doctors have only been able to perform a general virus test and then had to sequence and interpret the genome—a difficult task for smaller labs, for facilities in countries where it’s not easy to transport samples or staff aren’t trained thoroughly, or those handling a large number of patients who need to be tested. Last week, WHO published its list of urgent global health challenges facing the next decade, which included climate change, infectious diseases, anti-vaxxers, and AMR, among other challenges. The list was developed with input from experts around the world and “reflects a deep concern that leaders are not investing enough resources in core health priorities & systems, putting lives & economies in jeopardy," according to a tweet by WHO Director-General Dr. Tedros Adhanom Ghebreyesus. Last year, WHO published a list of ten global health threats for the year 2019 which also included climate change, AMR, weak primary health care, and vaccine hesitancy. WHO noted that these challenges demand a response from the health sector, governments, communities, and international organizations.