Breakthroughs Blog: Vaccines

Last week, the Australian government and the Indo-Pacific Centre for Health Security convened practitioners, researchers, educators, and decision-makers across the fields of public health, medicine, veterinary science, agriculture, government, defense, and anthropology for the first Global Health Security Conference in Sydney to examine the progress made to date in strengthening health systems and to identify gaps and opportunities for enhancing the international community’s ability to respond more efficiently and effectively to future health crises.GHTC was on the ground, following the official agenda, participating in side events, and speaking on a panel on innovative game changers to advance prioritization of research and development (R&D) in the Global Health Security Agenda. Here are our three key takeaways from the conversations:1. Innovation recognized as vital to advancing health security.The role of innovation in strengthening health security was highlighted throughout the week, with official sessions and side events showcasing innovative products, partnerships, and research central to advancing global health security.GHTC had a speaking role on a Global Health Security Agenda Consortium panel focused on game changers in global health security and used the opportunity to highlight key innovations that are being used on the front lines in the fight against Ebola in the Democratic Republic of the Congo. The panel hit on key themes that were echoed in other sessions, including the need to build local capacity for deployment of new tools and medicines, enhancing laboratory infrastructure, and strengthening health systems and community response capabilities. Much of the dialogue also centered around the need to engage local stakeholders in the development of innovations, ensuring that tools and technologies are designed and adapted for the local context, and that the deployment of treatment measures for emerging health threats is executed with firm community support to increase the chance of successful implementation.Other speakers throughout the week also highlighted the regulatory and implementation challenges that organizations and countries face when seeking to develop and deploy new tools and innovations and recommended strenghtening global governing structures that could facilitate addressing hurdles around approval timelines and streamline the processes.2. We need a strong focus on financing and sustainability. One core message that was consistent throughout the week was the need for a stronger focus on sustainability. Delegates agreed that states and organizations are too reactive in their mindsets, only responding to the latest outbreak and not taking the necessary preemptive steps, including through R&D, to develop the local, regional, and global capacities that are necessary to effectively combat emerging infectious diseases and other health threats. Ensuring that local infrastructure, laboratory systems, clinical capacity, and overall primary health care services are continually enhanced will allow for a more effective response.  Ebbs and flows in funding for epidemic diseases create additional challenges. The recent Ebola outbreak is a perfect example of how additional public resources can be mobilized to respond to global threats. However, absent a crisis, emergency preparedness and capacity building are often de-prioritized, and the necessary funding needed for additional innovation and product development is often lacking. Delegates called for a more durable approach of creating policies and incentives that catalyze investment for specific diseases, infrastructure, and health workers. Some also suggested looking to multilateral institutions for greater financial support for programmatic activities and creating stronger partnerships with the private sector. As one speaker put it best: “We must marry political capital with money.”3. Multisectoral approach critical to path forward.Are we asking too much of the health sector and not enough of everyone else? In the closing plenary, this question served as a call to action to engage non-traditional stakeholders and relevant decision-makers in other sectors to develop a truly multisectoral approach to strengthen health systems overall and develop the tools and capabilities in-country to detect, diagnose, and treat those threatened by global health threats.Ministers of Health have a difficult case to make when asking for more resources, financial or otherwise. The value of preventive measures is often invisible, since doing it right means there is no outcome. As global health practitioners, advocates, researchers, and decision-makers look for new ways to engage partners in different fora, such as the G20, building linkages to other sectors and government priorities will be key to creating the political buy-in necessary to advance the agenda around global health security.

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 large new study confirms previous research suggesting that a vaccine against rotavirus—a highly contagious virus that can cause severe illness and death in infants and young children— may have an added benefit: lowering the risk for Type 1 diabetes, an autoimmune disease that usually develops in childhood. The study showed a 33 percent reduction in the incidence of Type 1 diabetes among children who completed the three-dose RotaTeq series compared with unvaccinated children. RotaTeq, which protects against five different strains of rotavirus, is one of two orally administered rotavirus vaccines. Among those children in the study who took only one or two of the required three RotaTeq doses, there was no reduction in incidence compared with unvaccinated children. The reductions in risk in those who took the other version of the rotavirus vaccine, Rotarix, were not statistically significant. Approximately one million treatment courses of new child-friendly, easy-to-administer tuberculosis (TB) medicines have been ordered by 93 countries since they were first introduced in 2016, according to developer TB Alliance. Prior to the development of these treatments, caregivers would approximate children’s dosing by crushing or splitting bitter-flavored adult pills, which created adherence challenges. The new treatments meet World Health Organization (WHO) guidelines for childhood TB treatment and are dissolvable in water and flavored for palatability, making it easier for caregivers to administer. The 93 countries in which these treatments have been introduced account for 75 percent of the estimated global childhood TB burden. According to WHO, one million children are diagnosed with TB every year. US President Donald Trump recently issued an executive order calling for all US federal agencies to cut at least one-third of their advisory committees by September—a move many previous agency heads and critics say would weaken science-based regulation processes and the use of evidence-based policymaking. When excluding agencies that are mandated by law, a total of 462 boards and advisory committees that advise on government regulations and provide scientific oversight on other agency decisions are potentially on the chopping block as a result of the executive order. Critics of the executive order said that the one-third number put forth by the Trump administration seemed completely arbitrary and also pushed back on the notion that cutting the committees would save taxpayer dollars.

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 clinical trial in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”

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. Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year. A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country. Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.