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The Global Health Technologies Coalition (GHTC) condemns President Trump’s fiscal year (FY) 2021 budget request seeking deep cuts to global health and medical research programs. The budget proposes a 34 percent cut to global health programs at the US Agency for International Development (USAID) and the State Department, as well as significant cuts to public health and research agencies within the Department of Health and Human Services. If enacted, these reductions would have a disastrous impact on scientific advancements for global health. Cuts could mean fewer breakthrough vaccines, diagnostics, and treatments developed and more lives worldwide at risk of deadly diseases and debilitating conditions.“The Trump administration has once again failed to recognize what Congress has championed across partisan lines for decades: that US investments in global health research are fundamental to America’s global leadership and essential to building a stable, prosperous world where more people survive and thrive and dangerous outbreaks are quickly quashed,” said Jamie Bay Nishi, Director of GHTC. “At a time when our progress in global health is in a fragile state—with biology throwing up new challenges like the rise of drug-resistant HIV and tuberculosis and insecticide-resistant malaria parasites—any cuts to global health research programs put past gains at further risk. Additionally, the budget’s proposed elimination of HIV/AIDS research funding at USAID represents a broken promise by our President who pledged last year to ‘defeat AIDS in America and beyond.’” The Administration’s FY21 budget proposes widespread cuts to programs and funding lines that support research and development (R&D) of new drugs, vaccines, and other technologies to fight neglected diseases and conditions. Examples include the following, which are relative to FY20 enacted levels:Across the board cuts to global health programs at USAID:Elimination of HIV/AIDS funding.22.5 percent cut to Maternal and Child Health.11.3 percent cut to Tuberculosis.8.0 percent cut to Malaria.26.8 percent cut to Neglected Tropical Diseases.61 percent cut to Family Planning and Reproductive Health.6.8 percent cut to the Centers for Disease Control and Prevention (CDC) Center for Global Health.11.6 percent cut to the CDC National Center for Emerging and Zoonotic Infectious Diseases. 7.5 percent cut to the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases.9.0 percent cut to the NIH Fogarty International Center.In the budget request, the President does maintain support for specific programs critical to supporting global health security, including sustaining funding for the Biomedical Advanced Research and Development Authority—which advances medical countermeasures against emerging infectious diseases that pose a risk to Americans—and boosting funding for global health security accounts at USAID and CDC—which support efforts to strengthen health systems of partner nations to better recognize and contain outbreaks. GHTC welcomes this support, which is vital to enhancing global preparedness. However, taken together, the budget fails to recognize the interrelatedness of the persistent and emerging global health challenges we face. And the cuts proposed to biomedical research advanced through programs at NIH, CDC, and USAID would ultimately undermine our efforts to strengthen health systems globally. A life saved from Ebola or the novel coronavirus is not a life saved if it is later lost to tuberculosis or complications during childbirth. And a health system primed and ready to respond to an outbreak can only achieve so much without the right diagnostics to detect, vaccines to prevent, and therapies to treat a deadly disease.For the past three years, Congress has acted in a bipartisan manner to reject the President’s proposed budget cuts to global and medical research. We urge Congress to do so once again and maintain our nation’s strong legacy of humanitarian and scientific leadership in global health R&D.

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.