Breakthroughs Blog: CDC

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.

This week, months of tense negotiation between leaders in the Democratically-controlled US House of Representatives, the Republican-held Senate, and the White House concluded with the congressional passage of two massive spending packages encompassing all federal government spending for fiscal year (FY) 2020 —nearly three months behind schedule. Two continuing resolutions, passed by Congress to allow additional time for the process to play out after the start of the new fiscal year on October 1, have kept the government operating at FY19 levels, while from week to week, it was anyone’s guess whether the stalemate over funding levels and contentious items like border wall funding could be broken to avoid another government shutdown.A long process to produce two very long billsIn November, the appropriations “cardinals”—chairs and ranking members of both chambers’ Appropriation Committees—announced they had reached a deal on overall spending for each of the 12 appropriations bills, figures known as 302(b)s. This marked a critical step in the negotiations, given that at the time the House and Senate passed a two-year budget deal over the summer, each chamber had been working off of different overall blueprint funding envelopes: The House had already passed its appropriations bills assuming much higher funding levels than were ultimately included in the deal, while the Senate was developing its bills under the more modest final caps.Once the gulf was bridged and the 302(b)s were set, the leaders and their staff worked quickly to develop final compromise appropriations bills, which they grouped into two “minibus” funding packages released on December 16: a “national security appropriations” minibus and a “domestic priorities and international assistance appropriations” minibus, which included the bills for Labor, Health and Human Services, and Education (LHHS) and State and Foreign Operations (SFOPS).Funding increases included for several key accounts The later minibus encompassing LHHS and SFOPS was a mixed bag for accounts that support global health research and development (R&D). In the LHHS division of the minibus, overall funding for the National Institutes of Health (NIH) was boosted 6.7 percent from FY19 enacted levels—including increases of 6.7 percent for the National Institute of Allergy and Infectious Diseases, 3.3 percent for the National Center for Advancing Translational Sciences, 3.4 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and 3.4 percent for the Fogarty International Center. The joint explanatory statement accompanying the division also notes “an increase of no less than $25,000,000 over the fiscal year 2019 level for HIV and AIDS research” at NIH.The Centers for Disease Control (CDC) saw even greater overall growth than NIH, with an increase of 8.7 percent; however, GHTC-priority accounts that finance global health R&D were mostly flat-funded. While the Center for Global Health (CGH) received a 16.8 percent bump, the entirety of the increase went to Global Public Health Protection—which funds global health security activities—and a new Global Tuberculosis line—which represents level funding of an amount previously transferred annually from a domestic tuberculosis (TB) line to support global TB activities. All other CGH lines were flat-funded. The National Center for Emerging and Zoonotic Infectious Diseases got a modest 1.6 percent bump. The final GHTC priority account in the LHHS bill, the Biomedical Advanced Research and Development Authority (BARDA), was flat-funded.The SFOPS division of the minibus increased overall funding for Global Health Programs at the State Department and US Agency for International Development (USAID) by 2.9 percent. This is slightly lower than what had been proposed in the Senate SFOPS bill earlier this fall and significantly lower than the House proposal to increase by 5.2 percent, but overall still a positive trend reflecting strong support for global health among appropriators, who were working under the constraints of a modest overall SFOPS allocation in the final agreement. At USAID, most health area-specific allocations were flat-funded or increased by about two to four percent—the big exception being the Global Fund for AIDS, Tuberculosis, and Malaria, which was increased by 15.6 percent to reflect the higher pledge made by the US government at the Global Fund’s international pledging conference in October.Report language signals policy support for global health R&DGHTC successfully advocated for the inclusion of several sections of report language, included in the original House and Senate SFOPS bill reports, that will hold under the final agreement. Report language serves as guidance from Congress to US agencies on how it would like to see funding implemented. Language that will hold for FY20 includes GHTC-supported language on USAID’s important role in and reporting on health-related R&D and inter-agency collaboration and coordination on global health product development, as well as support for “CDC’s continued and enhanced work in research and development aimed at creating new tools to respond to health threats at home and abroad” and BARDA’s contributions to emerging infectious disease outbreaks and other naturally occurring threats.The “domestic priorities and international assistance minibus” not only included some positive funding increases and report language, but also advanced a bill supported by GHTC—the End Neglected Tropical Diseases (NTD) Act, which supports R&D activities by USAID to control and eliminate NTDs.The House passed both packages Tuesday afternoon, with the Senate following suit Thursday and now the bills are awaiting signature by the President. GHTC applauds Congress for their strong continued support for global health R&D evidenced by the final deal and looks forward to building on this foundation for our advocacy as we enter a new decade full of opportunities for global health innovation.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dan Littlefield, who we met at the American Society of Tropical Medicine and Hygiene Annual Conference. Dan co-founded a cold-chain engineering company that worked with the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority to distribute Ebola vaccines for clinical trials in Sierra Leone.My name: Dan Littlefield, MSWhere I work: Modality Solutions LLC I’m funded by: US Centers for Disease Control and Prevention (CDC), Biomedical Advanced Research and Development Authority (BARDA)My research: I’m a principal and one of the founding members of Modality Solutions. We’re a cold-chain engineering company that’s headquartered in League City, Texas, just outside of Houston. We do a lot of work with pharmaceutical and biotech companies to ensure their product, when it gets to the patient, is just as good as when it left manufacturing.Back in 2015, we were contacted by a contractor for the US government because there was a critical need in West Africa to support getting vaccines there as part of a phase III clinical trial that the CDC and BARDA were sponsoring in Sierra Leone for an Ebola vaccine. Motivation: We’re a growing company, we recruit a lot of young engineers, and when I talk to engineers, I find that we all love to do engineering work, but we also all like the direct impact of helping people. And one of the great things about the work we’re doing, especially with the emergency response clinical trials, is that there is a direct tie between the work we’re doing and how we’re saving lives.Why US federal support is critical: First, this is a national security issue because diseases like Ebola are dangerous. They’re dangerous to civilian populations in West Africa and potentially dangerous to US populations as well. And I think there’s an important diplomatic aspect to it. A lot of these countries are allies to the United States, and one of the ways to lift them up and improve living conditions in those countries is to go and do this kind of work. It also provides a stabilizing influence and improves local capabilities as well. That’s one of the things we try to focus on: it’s not about going in and doing the work and leaving, it’s about going in and training the local staff because a lot of very smart pharmacists and medical doctors don’t have a lot of experience dealing with heat transfer and thermal packaging and managing temperature-sensitive pharmaceuticals. If we can go in and transfer that knowledge, it really enhances them and helps them for the future, not just for clinical trials, but even just for standard vaccine strategies and drug treatments.When I’m not in the lab: My hobby is that I work as a reserve patrol sergeant with the Galveston Sherriff’s office. Galveston County is a big county just south of Houston. I work uniform patrol there, and I’m a weapons and tactics instructor for the department—so that fills up the rest of my time.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dr. Aileen Marty, who we met at the American Society of Tropical Medicine and Hygiene Annual Conference. Dr. Marty works at Florida International University and serves on the President’s Advisory Council for Combating Antibiotic-Resistant Bacteria.My name: Aileen Marty, MDWhere I work: Herbert Wertheim College of Medicine, Florida International University I’m funded by: The US government has supported my research since I began doing research back in the early 1970s. Right now, I’m involved with PACCARB, the President’s Advisory Council for Combating Antibiotic-Resistant Bacteria.My research: We’re interested in not only resistance by bacteria to antibiotics, but also by other pathogens such as fungal agents, and eventually hope to also focus on antihelminthic agents, and so forth. We are taking a look at it from a one health perspective, which means we try and understand how the agriculture industry may impact the use and availability of antimicrobial agents for humans, what is going on in the environment that’s also altering these things, as well as stewardship and appropriate use of antibiotics and antimicrobials in hospitals and in clinics throughout the United States and throughout the world, and see how those interface with one another. The CDC [US Centers for Disease Control and Prevention] recently put out a document about antimicrobial resistance that’s highly important. It says we’re already in an era where, for a number of very serious bugs or germs, we are out of antibiotics that actually work. If we do not solve this problem, we’re going to find ourselves in the situation we were in prior to the 20th century. And that impacts much more than infections directly, because modern medicine relies on us not having infections in order to do the surgeries that we’re doing. And to help people with autoimmune diseases like psoriasis or cancer treatments that decrease a person’s immune systems, we depend on the availability of good functioning antibiotics and antimicrobial agents at the right time in the right place for the right patient.Motivation: I love humanity—and I seriously believe that we all have a role to play in making sure that we leave behind a better world than the world we came into. And I become very inspired when I work with young minds, and I make sure that they see the connections between the different systems of the world and how we need to be stewards of the earth.Why US federal support is critical: We mustn’t think of it only in terms of it being global. You must realize that we in the United States are part of the globe. Moreover, individuals who live in the United States, who are citizens of the United States, travel worldwide. And what happens in Bangladesh has an impact on what happens in New York. Look at the recent measles outbreak in New York state, for example. That outbreak originated with an outbreak in Ukraine that passed via Israel and was brought to the United States—and think about what that has done. When we manage outbreaks where they arise, wherever that is, we minimize the footprint there and decrease the risk everywhere. When I’m not in the lab: In my personal life, I have a huge family, which I love dearly, and many, many good friends, and we spend a lot of time coming up with good community plans for helping people. And I belong to the Florida Clinicians for Climate Action, and through that organization we are going to synagogues and churches and other houses of worship where we are explaining the public health impacts of climate change to our people.