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 malaria vaccine candidate showed up to 77 percent efficacy in a phase 2b trial among children in Burkina Faso, according to results published by researchers at the University of Oxford’s Jenner Institute. The vaccine is the first to meet the World Health Organization goal of 75 percent efficacy. Developers have begun recruitment for a large-scale phase 3 trial to test the vaccine for safety and efficacy in 4,800 children across four countries. Following final trial results, Oxford would apply for regulatory authorizations, with a best-case scenario of approval by the end of 2022, according to the director of the Jenner Institute. The researchers have made a deal with the Serum Institute of India to manufacture the vaccine at large scale and low cost. It has pledged to deliver 200 million doses a year if the vaccine is licensed.The National Institutes of Health (NIH) is launching three new clinical trials to evaluate COVID-19 therapeutics, including one trial for severely ill, hospitalized patients; one for a polyclonal antibody treatment; and one to assess repurposed drugs for COVID-19 symptoms. The trial for hospitalized patients will test a combination of NeuroRx’s Zyesami, which is a formulation of aviptadil acetate, and Gilead’s Veklury, which is the antiviral remdesivir. The antibody trial will test SAB Biotherapeutics’ investigative polyclonal antibody in mild to moderate cases of COVID-19, and the study on repurposed drugs will evaluate existing over-the-counter drugs to be used at home. All three trials are part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership.Preliminary data on Pfizer’s and Moderna’s COVID-19 vaccines bolsters evidence that the mRNA shots are safe during pregnancy, based on reports from more than 35,000 women in the United States who received the doses while pregnant. The new evidence, published in the New England Journal of Medicine last week, showed rates of miscarriage, premature births, and other complications were comparable to those observed in pre-COVID-19 data on pregnancy. The study was led by US Centers for Disease Control and Prevention researchers, who noted continued monitoring and evidence is still needed, including on women who get COVID-19 vaccinations in the early stages of pregnancy.

2021 is shaping up to be an extraordinarily consequential year for US policy for global health and medical research, as a new presidential administration and Congress take charge against the backdrop of a global pandemic that has killed 1.6 million people worldwide and set back decades of progress in global health. As 2021 begins, here are some of the top policy issues GHTC will be tracking: 1. Will the United States remain missing in action on the global COVID-19 response or finally step up? Global health advocates spent much of last year repeating the aphorisms “no one is safe until everyone is safe” and “a global crisis requires a global response”—which seemingly fell on the deaf ears of a Congress and administration consumed by the magnitude of the COVID-19 crisis within our own borders. Though Congress last year appropriated roughly US$2 trillion in emergency funding to respond to the pandemic, plus that much more in loans and tax relief, less than one-half of 1 percent of that funding was earmarked to support the international response—marking a major departure from the US government’s approach in past global health emergencies like Zika and Ebola, when it stepped up with both resources and global leadership.  While the $4 billion in funding for Gavi, the Vaccine Alliance, was a bright spot in the fifth emergency supplemental funding package passed at the end of December, it only meets a fraction of the interconnected needs for a strong global response to this global health emergency. As a new administration and Congress take the helm later this month, advocates are continuing to push for $20 billion in emergency funding for the global COVID-19 response. Within this are specific asks for the United States to join and contribute to the Access to COVID-19 Tools Accelerator (ACT-A) and its lead partners, including the Coalition for Epidemic Preparedness Innovations (CEPI), and for Congress to resource the US Agency for International Development (USAID) to advance COVID-19 innovations designed for low-resource settings. With greater political support for these proposals coming from the Democrat-controlled House than the now Republican-controlled Senate, future prospects may depend as much on the outcome of today’s Senate runoffs in Georgia as the hard work of advocates. Yet, beyond these budget battles, the incoming Biden-Harris administration can pursue other direct means to support the international response, including leveraging existing efforts like Operation Warp Speed to continue to advance next-generation tools suited for the needs of low-resource settings and donating any excess vaccines globally once immediate US needs are met. [Editor's update: On January 20, the Biden-Harris Administration announced that the United States would join ACT-A. The administration also outlined a proposal for a sixth emergency supplemental package that includes $11 billion in funding to support the international response to COVID-19 and mitigate the pandemic's impact on global health, though it will ultimately depend on Congress as to whether the plan will move forward. The two Democratic Party candidates, Jon Ossoff and Rev. Raphael Warnock, won the Georgia runoffs giving Democrats functional control of the Senate with Vice President Kamala Harris as a tie-breaking vote.] 2. Will we recommit to multilateralism—and fund it? The last four years have been a dark era in US multilateral engagement, punctuated most conspicuously by the Trump administration’s move last July to initiate US withdrawal from the World Health Organization (WHO). While the Biden-Harris administration has thankfully pledged on day one to end this withdrawal, this is only the first step in rebuilding US credibility on the global stage and advancing meaningful multilateral reforms. As COVID-19 has shown, much work needs to be done to build a smarter, more responsive international system for public health and emergency preparedness, including for research and development (R&D). We hope that the Biden-Harris administration will work alongside allies now leading these processes and signal strong support for reform efforts. In addition to pushing for the US government to re-engage with WHO—and fulfill outstanding financial obligations—and join ACT-A efforts, GHTC is also calling for the United States to formally join CEPI via a $200 million annual commitment and work alongside our partner countries in the Global Health Security Agenda (GHSA) to revamp GHSA’s Workforce Development & Medical Countermeasures Action Package to address gaps in R&D capacity. [Editor's update: On January 20, the Biden-Harris Administration sent a letter to United Nations Secretary-General António Guterres ending US withdrawal from WHO.] 3. Will we pursue and finance a “build back better” agenda for global health?  The COVID-19 pandemic has exposed how our nation has woefully underinvested in our domestic and global health infrastructure. And while the burden and death toll of COVID-19 is staggering on its own, the full impact of the pandemic is coming into clearer view. Due to pandemic-related disruptions, health programs worldwide have faced challenges sustaining routine immunization programs and treatment services for HIV and tuberculosis, which could cause millions more deaths, and many health researchers have had to pause promising projects. The latter is a key finding from a report GHTC released last month which found the global health R&D sector is being weakened by pandemic pressures that are diverting funding and expertise away from other long-standing threats, multiplying costs for supplies and operations, and putting clinical trials and other scientific endeavors worldwide on indefinite hold. Reflecting on this devastation, it’s clear that an “appropriations as usual” approach will no longer suffice. After years of largely flat-funding health agencies and programs like the Centers for Disease Control and Prevention, USAID Global Health Programs, and the Biomedical Advanced Research and Development Authority (BARDA), Congress must take bold action to boost their budgets—and sustain strong growth at the National Institutes of Health—to ensure these programs have the resources needed to fulfill their important mandates and help their implementing partners restart activities and mitigate added costs and challenges from the pandemic. 4. Will the incoming administration reinvigorate and tap USAID capabilities after four years of neglect? USAID has faced a tumultuous last four years, as the Trump administration has repeatedly sought to slash the agency’s budget and instill controversial appointees. And when President Trump mobilized his administration’s pandemic response infrastructure for COVID-19, he exposed his ignorance of the agency’s value once again. The White House did not include the USAID administrator—the head of the US agency foremost charged with advancing global health—on the Coronavirus Task Force, and it floated proposals to shift US leadership of global pandemic preparedness and response activities away from the agency. Meanwhile, Congress provided USAID with minimal emergency funding to support partner countries in responding to the pandemic, stretching already thin global health programs. Despite taking these bruises, USAID, with its expansive on-the-ground presence worldwide, continues to possess unique capabilities and expertise in global health that will be vital for the incoming Biden-Harris administration to tap and reinvigorate as it seeks to end this pandemic—while also combating long-standing and future health threats. One area the agency has rich expertise in is developing and adapting health technologies for use in low-resource settings where barriers like lack of reliable cold chains or laboratory capacity can necessitate different types of tools. To leverage this expertise and bolster the agency’s leadership in this arena, GHTC is calling for the creation of a Chief Science and Product Development Officer role to coordinate and elevate best practices across the agency’s health area–specific innovation programming and the establishment of a new USAID Global Health Security Grand Challenge program to rapidly elevate and advance innovation solutions for these settings. [Editor's update: The Biden-Harris Administration has nominated Amb. Samantha Powers for the position of USAID Administrator and announced that the USAID Administrator position will be elevated as a member of the National Security Council.] 5. Will we proactively bolster BARDA’s role in pandemic preparedness in COVID-19’s wake? BARDA entered 2020 as a relatively obscure federal agency responsible for developing medical countermeasures against health threats and ended it as a household name entrusted with an influx of COVID-19 emergency funding 42 times the size of its annual appropriated budget—as the agency became a key player in the US government’s ambitious Operation Warp Speed. Prior to the emergence of COVID-19, GHTC had pushed unsuccessfully for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza, recognizing the real and present danger they pose alongside that of bioterror and man-made threats which precipitated the agency’s founding in the wake of the anthrax attacks of 2001 and have remained its historic focus since then. While the agency has been previously engaged in advancing products for EIDs, including Ebola and Zika, much of its funding to do so has come through emergency funding packages, rather than through annualized, sustained funding. This “boom and bust” cycle of Congress providing funding to the agency only after a crisis hits is not a good recipe for improving epidemic preparedness and must change. In the wake of COVID-19, GHTC is continuing to push for a permanent funding line, with an annual appropriation of $300 million, to enable BARDA’s sustained work on a range of EIDs and other naturally occurring health threats. GHTC is also advocating for the agency to place greater priority on ensuring, where possible, that the products it funds are designed to be readily deployable in low-resource and austere settings—recognizing we can’t prevent and end epidemics and pandemics unless we can ensure lifesaving tools can reach everyone, in every corner of America and the world. 6. How do we harness lessons learned to supercharge a new era of innovation? As the first COVID-19 vaccines are being delivered to health workers across our country, much is being written about this historic achievement and the power of science: just 11 months after scientists got their hands on the genetic sequence of the virus, we now have two effective vaccines approved by the US Food and Drug Administration for emergency use—a truly staggering achievement. Backed by considerable resources and building on the backbone of decades of investment in HIV/AIDS, tuberculosis, malaria, and other infectious disease research, scientists and product developers have poured their energy into fighting COVID-19, and in doing so, they have leapfrogged science to incorporate emerging approaches like mRNA vaccines, monoclonal antibodies, novel clinical trial designs, and more that could revolutionize the fight against other global health challenges. While there are many R&D lessons yet to be gleaned from this crisis, two already stand out: 1) With adequate resources and political will, science can solve health challenges that once appeared insurmountable, and 2) When governments pursue and finance product development with a clear end-to-end plan in mind—working in partnership with product developers to advance products each step of the way from early research through product procurement—we can achieve progress at speeds previously unimaginable.  It is our hope US policymakers will embrace these lessons learned in structuring and financing global health research efforts so we can supercharge a new golden era of global health innovation.

COVID-19 is an unprecedented global health crisis. Just as every sector is grappling with unforeseen challenges, global health advocacy has been continuously adapting to a policy environment in flux. As part of this community, the Global Health Technologies Coalition (GHTC) has been responding by:Reporting on the latest developments in COVID-19 research and development (R&D).Tracking COVID-19’s impacts on the R&D ecosystem.Sharing key US and multilateral policy updates with our members and partners.Developing and advancing specific policies that would drive creation of new tools for countering COVID-19 in low-resource settings, especially in low- and middle-income countries (LMICs).GHTC applauds many of the actions taken by lead US policymakers over the last several months. Congress has appropriated more than $10 billion for research to respond to COVID-19 through four emergency supplemental bills, and this funding is driving high-impact innovation at record speed. Yet many of the new products that result from this innovation will be ill-suited for low-resource settings, which often lack electricity, adequate hygiene, highly trained health care workers, laboratory networks, robust supply chains, and other attributes often taken for granted in well-resourced systems. For these settings, we need different innovations:Drugs that are easily transported and administered without the need for highly trained health workers.Rapid diagnostic tests that can deliver results at point of care without using complex laboratory equipment.Vaccines that are single dose, can be stored at room temperature, can be rapidly produced and distributed, and are easily administered (ideally through ingestion, a patch on the skin, or an electrical pulse rather than an injection). Medical devices, such as specially designed non-invasive ventilators, IV infusion monitors, and oxygen delivery devices, that require minimal technical expertise, have fewer and more easily replaceable parts, are quickly manufactured, and are battery operated.Personal protective equipment that is durable, reusable, open-source, and can be quickly manufactured and adapted in a variety of settings.Through our US and multilateral policy efforts, GHTC has been advocating for policies that would foster these needed products. In our US advocacy, we are pushing Congress for three funding lines that would drive innovation at the US Agency for International Development (USAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Centers for Disease Control and Prevention (CDC):$200 million for Global Health Programs at USAID to advance and deliver innovations to help LMICs prevent, prepare for, and respond to COVID-19 and other pandemic threats. These innovations should be specifically designed for low-resource settings and should include vaccines and vaccine delivery systems; diagnostics; therapeutics; medical devices; personal protective equipment for frontline health workers; health facility innovations; and the financing, manufacturing, and delivery systems these essential resources require.At least $200 million to CEPI to advance vaccine candidates for SARS-CoV-2. CEPI is advancing nine vaccine candidates and has put forward a $5 billion global ask to advance this portfolio. US support for CEPI will help ensure that vaccines developed will be deployed effectively and affordably worldwide.Robust funding for the CDC Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases to support the development and deployment of essential tools to combat COVID-19 globally.In our multilateral advocacy, GHTC has been pushing back against the United States’ retreat from international leadership on COVID-19 R&D, including the decision to withdraw from the World Health Organization (WHO) in the middle of the pandemic. GHTC advocates that the United States should work with other global leaders to proactively invest in global product development, manufacturing capacity, and product delivery mechanisms, including the Access to COVID-19 Tools (ACT) Accelerator, which could be instrumental in helping LMICs finance the purchase and administration of COVID-19 vaccines, treatments, diagnostics, and other tools. GHTC has also been pushing other G7 and G20 leaders to fill the funding gaps for the ACT Accelerator and to support other financing mechanisms such as a World Bank global health security challenge fund and health systems strengthening investments by regional development banks.GHTC is also engaging with the Global Health Security Agenda (GHSA) and pushing for the explicit inclusion within GHSA of R&D for diagnostics and medical countermeasures to respond to emerging health threats.Finally, GHTC has been working with other global stakeholders to assess how new COVID-19 product development and deployment mechanisms could be used to reshape the global R&D ecosystem and benefit other critical global health priorities.To support our US and multilateral policy asks, GHTC is tracking US government and multilateral-supported COVID-19 R&D, publishing materials to help policymakers and the public better understand these research efforts, and leading and supporting our partners with aligned messaging:GHTC COVID-19 R&D Tracker [Editor note: This was discontinued in 2021]COVID-19 Vaccine 101: The Facts that MatterGHTC maps the US agencies involved in Global Health Security R&DGHTC-led Congressional letter to support R&D for the international responseGHTC featured in Global Citizen: “To Defeat COVID-19, the United States Must Invest in Innovations for All”GHTC defends WHO’s role in global R&D response to COVID-19GHTC condemns US withdrawal from WHOGHTC endorses FIND’s Call to Action on COVID-19 testingThis is the first global health crisis in this century to significantly affect every person living in the United States and around the world—a catastrophe that could raise awareness and support for global health R&D. GHTC will continue to leverage this moment and emphasize the narrative that links all the issues we work on, that global health and global health security can never be assured until we have a robust, coordinated, and global R&D ecosystem that includes the populations, diseases, and conditions too often overlooked.

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 second-largest Ebola outbreak in history—which has infected 3,500 people and killed 2,250 in the Democratic Republic of Congo (DRC) since August 2018—is down to its last chain of transmission despite ongoing violence that has hampered response efforts. The waning of the Ebola outbreak comes as the outbreak of the novel coronavirus, COVID-19, has captured global attention and potentially funding as well. According to a World Health Organization (WHO) spokeswoman, “Funding needs [for the Ebola response] have not as yet been fully met, and currently there is a risk there will not be funding for WHO activities beyond February.” Despite the waning of Ebola cases in DRC, last Wednesday, an independent committee that advises WHO unanimously agreed the Ebola outbreak continues to be a public health emergency—a designation recently extended to the COVID-19 outbreak. Though WHO and others have worked tirelessly to contain Ebola, the region’s health system remains weak and the likelihood of future outbreaks is high. The experimental antiviral drug remdesivir successfully prevented disease in rhesus macaques infected with Middle East respiratory syndrome coronavirus (MERS-CoV), according to a study performed by the US National Institutes of Health and supported by the Biomedical Advanced Research and Development Authority. Remdesivir both prevented disease when administered before infection and improved the condition of the macaques when given after the animals already were infected. MERS-CoV is closely related to COVID-19, which emerged in Wuhan, China in December of last year and has grown to be a public health emergency. The promising results of this study support the case for additional clinical trials of remdesivir for MERS-CoV and COVID-19. Gilead Sciences developed remdesivir and collaborated in the research. On Monday, February 10, President Trump released his proposed budget for fiscal year 2021, which seeks deep cuts of US$3 billion to global health funding. The proposed cuts include a 34 percent reduction to global health programs at the State Department and US Agency for International Development (USAID) and a seven percent cut in funding to the Centers for Disease Control and Prevention (CDC)’s Center for Global Health. President Trump’s budget also proposed a 58 percent reduction in funding to the Global Fund to Fight AIDS, Tuberculosis and Malaria and a 50 percent cut in funding to WHO. Despite these widespread proposed cuts, the budget did include some boosts in funding—a $50 million increase for CDC’s global health security activities and $15 million for USAID’s Global Health Security programs. President Trump’s budget has been condemned by public health experts and many lawmakers, who have spoken out against the cuts which are unlikely to go into effect.