Breakthroughs Blog: HHS

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.

This afternoon, President Trump signed into law a spending bill that pairs full-year fiscal year (FY) 2019 funding for Labor, Health and Human Services (LHHS) and Defense with a stopgap measure to keep other agencies funded through December—staving off a partial government shutdown on the eve of the end of the fiscal year. The “minibus”-plus-continuing resolution (CR) legislation boosts funding for medical research across the Department of Health and Human Services (HHS) for FY19, while maintaining funding for global health at the US Agency for International Development and the Department of State through December 7 via the CR measure. Given Trump already signed into law a spending package covering Energy, Veterans Affairs, and the Legislative Branch, now 75 percent of the government is funded for the full fiscal year; while the remaining agencies will remain funded through the CR as lawmakers work to finish full-year funding bills for them. While this year’s appropriations approach may be unusual, by recent historical standards, it was also remarkably efficient: Today marks the first time in 22 years that the government has succeeded in getting at least five of the twelve annual spending bills signed into law before the new fiscal year begins. Here’s a breakdown of how global health and medical research funding fared in the spending package: National Institutes of Health The National Institutes of Health received an impressive US $2 billion boost overall (a 5 percent increase over FY18), including increases of 3-9 percent to each center involved in global health research and development (R&D). In increasing order, the package provided a boost of 3.4 percent for the Fogarty International Center, 3.75 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 5 percent for the National Institute of Allergy and Infectious Diseases, and 8.62 percent for the National Center for Advancing Translational Sciences. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) also saw an overall increase from FY18 – depending on how you do the math. In the FY18 omnibus appropriations bill passed in March, CDC received a one-time $480 million funding infusion to support the construction of a replacement Prevention Biosafety Level 4 high containment laboratory to enable continued research on dangerous pathogens like Ebola. Less the cost of that lab, CDC’s overall year-on-year budget rose 1.63 percent. The Center for Global Health was level-funded, while the National Center for Emerging and Zoonotic Infectious Diseases received a 1 percent bump. The bill also established a new CDC-wide Infectious Disease Rapid Response Reserve Fund with an initial infusion of $50 million, a key win for global health security advocates. Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) saw a $25 million budget increase in the bill (a 4.66 percent boost). This—coupled with the House passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018—earlier this week, which reauthorized BARDA and authorized $250 million annually for five years for a new emerging infectious diseases program—is welcome news for those looking to BARDA to play an increasingly robust role in global health R&D. However, given the Senate still needs to pass their own version of a bill and continues to pursue a general all-hazards approach in their bill, a call out for emerging infectious diseases may not come to fruition in the final reauthorization. US Agency for International Development & State Department Global health accounts at the US Agency for International Development and the Department of State will be level funded through December 7 since the funding package signed into law today includes a CR for the State and Foreign Operations appropriations bill.   The bottom line: Yet again, strong congressional support has protected global health R&D from deep cuts to key agencies proposed in the President’s budget request and even won significant increases to some accounts. As we get closer to the midterm elections, we will keep a close eye on political developments that could affect our funding prospects for FY20.

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 US government has launched its first national biodefense strategy to address naturally occurring threats, such as outbreaks of infectious diseases, alongside protections against bio-chemical weapons. The policy puts all aspects of US biodefense under one roof and establishes a Cabinet-level committee to coordinate activities. Provisions within the strategy also call for increased surveillance and research of potential global threats to prevent outbreaks from reaching American shores. Health security experts hope the release of this strategy will help to better prepare the United States to deal with such threats. For the fourth year in a row, tuberculosis (TB) remains the world’s top infectious killer—killing more than 1.6 million people annually, according to the World Health Organization’s (WHO) global TB report. The disease will receive increased political attention this week, as world leaders gather for the first-ever United Nations high-level meeting on TB. TB advocates hope the meeting will rally the global support and resources required to expedite progress. Debates between the United States and other countries regarding intellectual property had momentarily derailed negotiations on an accompanying political outcome declaration, but that is now expected to be endorsed on Thursday. The WHO TB report, which was released in advance of the meeting, also highlights a US $1.3 billion gap in funding for the research and development of new treatments to address the 3.6 million people suffering from TB who are not receiving treatment. The National Institute of Allergy and Infectious Diseases and the Duke University School of Medicine have begun enrollment for a Phase 1 trial of a new antimalarial drug, called DM1157, to test its efficacy in humans. DM1157 is a modified version of chloroquine, an antimalarial drug to which many strains of the most deadly form of malaria have grown resistant. This modified version of chloroquine interferes with the metabolism of the parasite and inhibits its ability to expel the drug. As the number of drug-resistant malaria cases grows, DM1157’s positive results during efficacy trials in animals provides hope for its efficacy in human cases.

Last Friday, President Donald Trump signed into law a US$1.3 trillion spending bill to fund the US government through the rest of fiscal year (FY) 2018. Reluctantly signed by the President among a flurry of “will he, won’t he” tweets, the legislation represents a forceful rebuke by Congress of the Administration’s proposal to drastically slash funding for global health and medical research programs. Key US agencies and programs that advance global health research and development (R&D) not only saw their funding protected in the spending bill, but many also saw increases. This outcome demonstrates that our community’s appeals and messages have not fallen on deaf ears and that Congressional policymakers on both sides of the aisle want to see the United States continue its leadership in advancing innovation to improve the health of those in need around the world. Here are some of the key takeaways from the 2,000+-page bill: US Agency for International Development & State Department While the Trump Administration proposed slashing funding for global health programs at the US Agency for International Development (USAID) and the State Department by 25 percent, Congress stood firm in protecting these programs. The bill ultimately sustained overall funding for these programs at FY17 enacted levels. A few programs received increases including a boost of $15 million for GAVI, the Vaccine Alliance; $20 million for tuberculosis (TB); and $15 million for maternal and child health. Funding for USAID HIV and AIDS programming and family planning at State and USAID, which the President proposed eliminating fully, was protected at FY17 levels. Congress also directed $135 million from repurposed Ebola emergency supplemental funding to support USAID’s global health security programs.   USAID plays a leading role in developing health technologies for low-resource settings through its various global health programs, so it is critical that these programs receive adequate funding, so they can continue to prioritize R&D among their other activities. In light of the President’s proposal for deep cuts to these programs, a combination of level funding for some programs and increases for others is a positive sign in the midst of a challenging budget environment. National Institutes of Health   Strong bipartisan support for the National Institutes of Health (NIH) continued for FY18. While the President proposed a 21 percent cut to NIH funding, the final spending bill instead provided the agency with an increase of $3 billion—8.8 percent—over FY17 levels. This represents a historic funding high for NIH in actual dollars with increases spread across various NIH institutes and programs. Notably, the National Institute of Allergy and Infectious Diseases received a 7.2 percent increase—39 percent above the President’s FY17 request—while the Fogarty International Center, which was targeted by the Administration for elimination, received a boost of 5.2 percent compared to FY17.   NIH is the world’s leading funder of R&D for neglected diseases, providing approximately 40 percent of total global funding, so any changes to its funding produce a ripple effect felt by global health research institutes and people around the world. It is encouraging to see Congress continue its record of bipartisan support for NIH and take action to strengthen our nation’s leadership in medical research. Centers for Disease Control and Prevention   The US Centers for Disease Control and Prevention (CDC) also received a plus up in the FY18 omnibus. The agency saw its funding increased by $1.1 billion—nearly 15 percent—over FY17 levels. This was in sharp contrast to the 16 percent cuts proposed by the Administration. The CDC Center for Global Health (CGH) received a 12 percent increase, compared to a 21 percent proposed cut. This included a $1.5 million boost for parasitic disease and malaria and a substantial increase of $50 million for global health security programming, which supports implementation of the Global Health Security Agenda (GHSA). Funding for global immunization and AIDS programming within CGH remained level. The National Center for Emerging and Zoonotic Infectious Diseases also received a more modest 5 percent increase over FY17 funding.   CDC plays a critical role in advancing technologies and improving health systems to better detect, prevent, and respond to infectious disease threats worldwide. There was much concern surrounding the FY18 budget for CDC as the agency is facing a funding cliff. CDC and USAID received $1 billion from the Ebola emergency supplement to fund GHSA, but this money is set to run out in 2019. As a result, the agency has already announced plans to scale back its GHSA work in 39 of 49 countries. While more funding is still needed to sustain these programs, and the agency has yet to clarify how it will adjust programming in light of its FY18 appropriations; it is promising to see Congressional appropriators recognize the value of CDC’s engagement in improving global health security. Biomedical Advanced Research and Development Authority   The Biomedical Advanced Research and Development Authority (BARDA), which develops medical countermeasures against health threats including emerging infectious diseases and antimicrobial resistance (AMR), also received a boost in the FY18 spending bill. The agency saw its funding increased by $25 million—about 5 percent—over FY17 levels.   BARDA has played an increasing role in R&D for naturally occurring threats and emerging infectious diseases in response to the Ebola and Zika epidemics. With its focus on bridging the “valley of death” in product development and its ability to use unique contracting mechanisms to forge innovative and long-term private-sector partnerships, BARDA is well positioned to make an impact in this space. However, the agency has been constrained by a lack of dedicated funding for its emerging infectious disease portfolio. While it is promising to see appropriators increase the agency’s overall funding for FY18, GHTC will be pushing for more dedicated funding for emerging infectious diseases in FY19. Department of Defense   The Department of Defense’s (DoD) activities in infectious disease research also saw increases in the omnibus. DoD’s Peer Reviewed Medical Research Program—a program that conducts research on AMR, diarrheal diseases, emerging infectious diseases, malaria, TB, and vaccine development for infectious diseases—received $330 million in funding, which is an increase of $30 million over FY17 levels.   The FY18 spending bill is a big win for global health R&D stakeholders and advocates, but this victory may only be temporary. The legislation funds the government through the end of September, and the Trump Administration has once against proposed drastic cuts to global health and medical-research programs for FY19. So while the ink dries on this year’s spending bill and we take a moment to celebrate, GHTC is already gearing up for another difficult battle ahead on next year’s budget.