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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.

The following statement—from Global Health Council, supported by the Infectious Diseases Society of America and the Global Health Technologies Coalition—was delivered at the 146th session of the WHO Executive Board Meeting on agenda item 15.4: The public health implications of implementation of the Nagoya Protocol.. Global Health Council, supported by the Global Health Technologies Coalition, thanks the chair and distinguished delegates for this opportunity to comment on the public health implications of implementation of the Nagoya Protocol.We support the objective of the Convention on Biological Diversity and of the Nagoya Protocol, including facilitating access to genetic materials and sharing the benefits arising from their use. However, we urge member states to give very careful consideration to the public health implications of any legislation aimed at implementing the Nagoya Protocol. From basic research through clinical trials, medical research is highly collaborative and routinely involves the sharing of organisms, pathogens, and research findings across borders. Any national implementation legislation should account for the need for the timely sharing of genetic material, ensuring that there are no major delays or barriers to the development or use of drugs, vaccines, and diagnostics.We call on the World Health Organization (WHO) in its normative capacity to continue assessing the impact of the Nagoya Protocol on public health and support a WHO review of all existing international pathogen sharing legislation and provisions governing sample-sharing. Member states should formally recognize those international pathogen sharing policies whose access and benefit sharing provisions result in a public health benefit.

The following statement—from Global Health Council, supported by the Global Health Technologies Coalition—was delivered at the 146th session of the WHO Executive Board Meeting on agenda item 14: Global strategy and plan of action on public health, innovation and intellectual property. Global Health Council, supported by the Global Health Technologies Coalition, thanks the chair and distinguished delegates for this opportunity to comment on the Global strategy and plan of action on public health, innovation and intellectual property.We applaud the World Health Organization (WHO) for its work on helping member states build regulatory capacity and work to pool procurement under the Essential Medicines List, and support WHO’s efforts to address regulatory barriers which ensure timely access to affordable and quality medicines.  We hope that WHO and member states can work to better leverage innovative structures, including product development partnerships and other novel mechanisms, in securing sustainable access commitments. Such innovative approaches accelerate the development of and access to essential health technologies targeting neglected diseases. Many of these stakeholders have experience managing intellectual property, supporting affordability, strengthening local research and regulatory capacity, and managing supply chains.We call on member states to encourage more research and development on conditions affecting vulnerable populations including children, adolescents, and young people, and urge WHO to continue its efforts to expand the Essential Diagnostics List. We strongly support WHO’s goal of increasing access to appropriate, affordable, quality-assured, and effective diagnostics in underserved regions of the world.

The following statement—from Global Health Council, supported by the Infectious Diseases Society of America and the Global Health Technologies Coalition—was delivered at the 146th session of the WHO Executive Board Meeting on agenda item 13: Neglected tropical diseases.Global Health Council, supported by the Global Health Technologies Coalition, thanks the chair and distinguished delegates for this opportunity to comment on neglected tropical diseases agenda item.Neglected Tropical Diseases (NTDs) are inextricably linked to poverty and inequality. These diseases exact a heavy toll, causing chronic illness, severe disfigurement, blindness, and even death. More than 1.5 billion people are estimated to require interventions against NTDs each year with many existing tools inadequate to effectively treat populations in low-income and low-resource settings. Increased attention in recent years has brought new resources to the fight against NTDs and fueled research breakthroughs. Yet, very significant gaps remain in the arsenal of tools needed to control and eliminate these diseases, underscoring the need for research and development (R&D) of new tools.We call on the World Health Organization (WHO) and member states to support programs that help catalyze innovation and build capacity to develop new drugs, vaccines, and diagnostics, and urge WHO to facilitate greater coordination across the full scope of diseases. Accelerated programmatic action could advance scientific understanding for developing new tools, improving strategies, and strengthening service delivery. We urge member states to fill key gaps by investing in R&D for new and improved treatments and prevention tools, including therapies designed for children and shorter, simplified regimens with fewer side effects.Finally, we ask WHO to support the official adoption of World NTD Day to continue to raise awareness and shine a light on these under-resourced diseases.