Breakthroughs Blog: Microbicides

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 week, the Coalition for Epidemic Preparedness (CEPI) announced an up-to-US$50 million investment over ten years in building the vaccine development capacity of Senegal’s Institut Pasteur. Following Africa’s major challenges in accessing COVID-19 vaccines during the pandemic, the investment aims to ensure the production of vaccines for low- and middle-income countries during future health crises, and to increase African autonomy over regional health security efforts. The first round of funding includes $15 million over three years, which will fund the development of manufacturing facilities. Last week at the World Economic Forum’s annual meeting in Davos, the World Health Organization (WHO) announced plans to set up a new TB Vaccine Accelerator Council to catalyze the development of tuberculosis (TB) vaccines. In launching the plan, WHO Director-General Dr. Tedros Adhanom Ghebreyesus noted the lesson learned during the pandemic that global, cross-sector commitments and partnerships can accelerate the vaccine research and development process. In addition to stressing the importance of strong TB programs and commitments from high-burden countries, the speakers at the launch event urged countries to renew their commitment toward combating TB by reinvigorating research efforts that have been historically stagnant.Also, at the meeting in Davos, Pfizer announced that it will make its entire portfolio of 500 drugs and vaccines available to 45 low-income countries at nonprofit prices. This collection of medical technologies includes patented and off-patient medicines, a range of antibiotics, as well as new vaccines and medicines as they are launched. This effort is an expansion of last year’s “An Accord for a Healthier World” initiative, which focused on a smaller number of patented products, including the COVID antiviral treatment Paxlovid. The initiative will provide more than a billion people access to important products, hopefully helping to address major global health challenges, including antimicrobial resistance which has arisen in part, due to challenges accessing a broad scope of treatments.

In recognition of World Mosquito Day on August 20, 2021, GHTC is testing our readers’ knowledge of mosquito-borne diseases and ongoing efforts to develop treatments, vaccines, vector-control innovations, and other tools to outsmart the world’s deadliest animal. Find out if you have achieved mozzie mastery by taking our quiz below. Loading...(function(i,s,o,g,r,a,m){var ql=document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if(ql){if(ql.length){for(var k=0;k

2017 was a year that brought changes, upheavals, and uncertainties for the global health and development community: From the inauguration of a US president that expressed skepticism about foreign assistance and beget uncertainty about the United States’ continued leadership in global health, to the election of a new leader at the World Health Organization (WHO) that faces a tough task of reforming the agency and proving it’s up to the job in the wake of missteps during the Ebola crisis. While the landscape seemed to shift continuously under our feet this year, the community was also buoyed by evidence of our shared progress and success. In developing countries, more women than ever have access to contraceptives. The end of polio is truly within sight. And we have the largest pipeline of promising global health technologies ever in history. As the year comes to an end, GHTC is reflecting on the global health innovation stories and news that shaped 2017. Here are some of those moments: 1. Coalition formed to develop vaccines to prevent pandemics The 2014 Ebola epidemic prompted some real reckoning by the global community and raised important questions on how we can be better equipped with the tools and systems to stop outbreaks before they become epidemics. While the world still remains woefully unprepared, 2017 saw an important step forward with the formation of the Coalition for Epidemic Preparedness Innovations (CEPI). Launched with nearly $600 million in funding from the governments of Norway, Japan, and Germany, and in partnership with the Wellcome Trust and the Bill & Melinda Gates Foundation, CEPI aims to develop vaccines against the diseases most likely to cause the next epidemic. 2. US global health and research funding saved from the chopping blockCDC researcher handles pathogen in biosafety lab. Photo: CDC/ Dr. Scott Smith  The year started on an ominous note with the release of the Trump Administration’s fiscal year (FY) 2018 budget proposal, which called for deep cuts to US global health and medical research programs for FY18 as well as proposed rescissions to the US Agency for International Development’s (USAID) global health funding for FY17. While advocates feared Congress would take a cue from the Administration as it finalized FY17 budget negotiations, champions in Congress stepped up and defended these investments. When the dust finally settled, the FY17 omnibus budget passed with sustained funding across these areas, including slight boosts to global health funding at USAID and the US Centers for Disease Control and Prevention, and a US$2 billion increase for the National Institutes of Health (NIH). While budget negotiations remain ongoing for FY18, advocates are optimistic Congress will continue to sustain strong funding for global health and medical research. 3. G20 makes first-ever pledge to support R&D to combat global health challenges The world’s wealthiest nations paid some serious lip service to advancing global health research and development (R&D) this year. In their 2017 summit declaration, G20 leaders committed to working together to advance R&D for antimicrobial resistance (AMR) and potentially pandemic diseases— marking the first time R&D for global health has featured on the G20 declaration. Leaders pledged support for coordinated R&D initiatives, like the WHO R&D Blueprint and CEPI as well as called for a new AMR R&D collaboration hub. Although the G20 focused on R&D through the lens of AMR and health security—which addresses only a portion of global health challenges—this was a good sign that the world’s leaders are embracing the importance of health R&D to global development. It is now imperative that words turn into concrete action and that leaders sustain this momentum as Argentina takes helm of the G20 in 2018. 4. Demise of an R&D pooled fund at WHONot all news can be good news. This year brought a disappointing resolution to an over decade-long effort to stand up a voluntary pooled fund at WHO to finance R&D for neglected diseases. At this year’s World Health Assembly, WHO announced that it would cease work on the pooled fund and its initial round of demonstration projects—citing a lack of contributions pledged to support the sustainability of the fund. While this is a disappointing end for global health advocates, on a positive note, WHO pledged to continue a companion effort—the WHO Global Observatory on Health R&D—which was created to facilitate coordination and guide prioritization for global health research. 5. WHO begins process to establish essential diagnostics listA PATH research examines onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKern One of the biggest innovations of 2017 could be something decidedly low-tech: a list. While WHO has operated the Model List of Essential Medicines for decades to guide countries in procuring drugs and treatments, this year a group of scientists asked an interesting question: If we have a list for medicines, why don’t we have one for diagnostics? After a sustained advocacy campaign, supported by GHTC, calling for WHO to establish an essential diagnostics list (EDL), the agency formally announced in June it would create an EDL and took the first step in doing so, creating an expert advisory group tasked with developed the list. While the list is not expected to be operational until early 2019, this welcomed move by WHO will improve diagnostic access and innovation and ultimately save lives. 6. Nonprofit-backed Chagas drug beats ex-“Pharma Bro” company’s bid for rival launch Readers always like a David vs. Goliath story, and this one captured a lot of media attention this year. This August, in a surprising move, a creative multisector partnership involving GHTC member Drugs for Neglected Diseases initiative (DNDi) successfully secured approval from the US Food and Drug Administration (FDA) for the Chagas drug benznidazole, achieving this milestone before a rival attempt by a company formally run by Martin Shkreli (aka “Pharma Bro”) to register their version of the drug. Under Shkrell’s leadership, this company announced plans to take benznidazole—a drug that has been around since the 1970s, but lacked FDA approval—and register it with the FDA to secure a tropical disease priority review voucher (PRV) to sell. It also expressed plans to its investors to then hike the price of the drug to nearly $1,000 a course (vs. the $60-$100 it’s now being sold at in Latin America). This alarmed advocates who worried the drug would become prohibitively expensive to the nearly 300,000 Americans impacted by Chagas’ disease. This partnership appears to be a win-win for both Americans and people around the world. The company involved in the partnership has committed to making the drug accessible to Americans at an affordable price, and under a provision in the partnership agreement, 50 percent of revenue from a PRV sale will be used to fund programs to expand access to the drug in the United States and other nations. 7. Innovators get creative in combatting the world’s deadliest animal Bill Gates famously reminded us that the world’s deadliest animal is not a shark or a lion, but the pesky, yet lethal mosquito. This year innovators got particularly creative in exploring ways to wipe out these deadly pests and the diseases they carry. Work continued on gene-drives, genetic modification of mosquitoes, and the introduction of the transmission-blocking Wolbachia bacteria. But scientists also tried to see if they could use mosquitoes rather than syringes to deliver malaria vaccines; created a crowd-sourced, mobile-based monitoring platform to track disease-carrying mosquitoes by the sound of their buzz; and innovated a way to introduce sterile mosquitoes into a population via temperature-controlled drone. 8. New global health technologies advance through pipelineOver the past year, several other promising new health innovations have moved through the development pipeline and one step closer to reaching people in need. Here are just a few highlights: A new low-cost, heat-stable rotavirus vaccine, ROTASIL—developed by GHTC member PATH—was found effective against severe rotavirus in Phase II clinical trials. A promising new HIV vaccine candidate that targets multiple strains of HIV—developed by Janssen Pharmaceutical Companies of Johnson & Johnson as well as the NIH National Institute of Allergy and Infectious Diseases (NIAID)—entered human clinical trials. This marks only the fifth time in history an HIV vaccine candidate has reached this milestone. The first vaccine specifically developed for leprosy entered a Phase I clinical trial, with results expected in 2018. A US Army-developed Zika vaccine candidate ZPIV performed well in three Phase I clinical trials, producing an immune response in more than 90 percent of participants. Building on the success of its monthly dapivirine microbicide ring, which is now under regulatory review, GHTC member the International Partnership for Microbicides announced the launch of clinical trials for a three-month vaginal ring that releases both dapivirine and a contraceptive. NIAID also sponsored Phase I and II trials of a promising Chikungunya vaccine candidate. Currently there is no available vaccine for the disease. A new, anti-malaria compound—developed by Novartis and GHTC member Medicines for Malaria Ventures—entered clinical trials in nine countries in Africa and Asia. Partners hope this new drug will help stave off the development of further malaria drug resistance and expects to complete Phase 2b studies by late 2019. A promising new oral therapy for sleeping sickness—fexinidazole—was found effective in curing the illness in Phase III clinical trials. The treatment—developed by DNDi and Sanofi—could receive regulatory approval as early as the end of next year. As we look forward to 2018, it is time for the global health community to redouble our efforts to make sure this vital progress in global health innovation continues to ensure that people around the world will have access to lifesaving and life-improving health technologies.

Meet Grace, Denise, and Sarah. At age 21, Grace is a single mother of two living in South Africa. Because her children need routine check-ups and immunizations, Grace frequently sees pediatricians and nurses, but rarely visits doctors for her own health needs. In Namibia, 19-year-old Denise is a first-time mother. She wants contraceptives but the few times she’s asked, the local pharmacist said they were available only for married women. And in Malawi, 18-year-old Sarah has started having sex, sometimes with male partners twice her age.  These three young women lead very different lives, but they all have one thing in common—they’re at high risk for HIV infection. Although Grace, Denise, and Sarah are not real people, their stories illustrate diverse challenges young women face, particularly in sub-Saharan Africa, where young women ages 15-24 are at least twice as likely to have HIV as men their age—and, in some regions, are more than eight times as likely to get infected. IPM's Sharyn Tenn with workshop participantsExisting HIV prevention strategies are not doing enough to reduce the high rate of infection among women because women still lack a range of options that address their diverse needs. While some women may feel comfortable discussing available HIV prevention options such as condoms with their partners, negotiating safe sex is not a realistic option for many others, including those at risk of sexual violence. In addition, while some women may be able to use a daily oral HIV prevention pill known as PrEP, in the three African countries where it recently become available, others may prefer a long-acting prevention method.The payoff for all of these tools spans far beyond individual women—evidence shows that when women are both empowered and healthy, they are more likely to have healthy families, educate their children, and make positive social and economic contributions to society. New discreet and long-acting HIV prevention tools have the potential to empower women to protect their own health and unlock their potential.My organization, the International Partnership for Microbicides (IPM), has developed one such tool–the monthly dapivirine ring. This flexible, silicone vaginal ring is the first long-acting, self-initiated method shown to safely help prevent new HIV infections in women.Results from two Phase III clinical trials last year—The Ring Study and ASPIRE—found that the ring safely reduced HIV risk among women in four African countries. Data from one study suggests that women who used the ring most consistently saw greater risk reduction, and that the youngest women, who saw little to no protection, appeared to be the least likely to use the product. Such adherence challenges are consistent with studies of other HIV prevention methods and underscore the urgent need to identify and overcome barriers to product-use for young women. The dapivirine ring. (Photo: Andrew Loxley) IPM is committed to doing all we can to understand how to help young women who want to use new HIV prevention technologies, like the monthly dapivirine ring, to do so consistently. Last month, we, along with AVAC, the US Agency for International Development, and Dalberg Global Development Advisors, co-hosted an event during the United Nations Commission on the Status of Women to take a holistic view of young women’s lives. Presenters shared examples of the ways HIV-prevention efforts can be informed by the very people who would benefit leveraging an approach called human-centered design, which places end-users and other key stakeholders at the center of the design and implementation process. This approach is being used to create concepts and materials to increase the adoption and sustained use of the dapivirine ring.Several insights shared at the event could inform future steps for the dapivirine ring, should it be approved for use and added to HIV prevention programs in sub-Saharan Africa. For example, the ring could be offered where women already regularly access health services, whether for themselves or for their children.Doing so would make access to the ring more convenient, and subsequently, may increase its uptake. Participants also suggested that a welcoming, environment may also help facilitate uptake as fear of judgment can be a powerful barrier to accessing and using HIV prevention products and services.We’re encouraged by these discussions, recognizing that they are one step in a long and iterative process of getting new HIV-prevention methods into the hands of women worldwide. Continuing to involve women in additional research on the ring and its possible introduction must continue if we are to realize its potential and pave the way for other technologies in the pipeline such as a three-month dapivirine-only ring and a multipurpose dapivirine-contraceptive ring. We’re currently pursuing regulatory approval for the dapivirine ring and looking to two open-label extension studies—DREAM and HOPE—currently underway, to gain insight into when, why, and how women use the ring now that its safety and efficacy are known, and to collect extended safety data.Expanding the toolkit of HIV prevention options available to young women would lower HIV infection rates, allow healthy women to pursue employment, and help sustain strong and productive workforces.The sooner we reduce the heavy HIV burden young women bear, the sooner we can empower a new generation to lead healthy and productive lives. Sharyn Tenn is the senior director for external affairs at the International Partnership for Microbicides.