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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. The National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-2 clinical trial has begun testing two monoclonal antibody therapies for treatment of mild to moderate cases of COVID-19. ACTIV-2, part of NIAID’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, was established in August to test investigational COVID-19 therapeutics, including Eli Lilly’s monoclonal antibody treatment LY-CoV555, which was subsequently granted emergency use authorization by the US Food and Drug Administration for a subset of mild to moderate COVID-19 patients. The recently begun trials will test BRII-196 and BRII-198, both monoclonal antibody therapies developed by Brii Biosciences that use synthetic versions of naturally produced antibodies to bind to viruses and prevent them from infecting cells. The study will begin with 220 participants, half of which will receive the treatment through intravenous infusions while the other half receive placebos.Convalescent plasma from patients previously infected with COVID-19 may delay or stop progression of illness in mildly ill older adults, according to a new study published in the New England Journal of Medicine. The data comes from a small randomized, controlled, and double-blind trial conducted by Fundacion INFANT in Buenos Aires, Argentina, which tested the effects of infusing convalescent plasma in older adults. Among 80 patients given convalescent plasma, 16 percent developed severe COVID-19, compared with 31 percent of the population given a placebo. In a modified analysis, results showed a larger effect after excluding a subset of patients who developed severe illness before plasma or placebo infusion. Authors of the study hope the treatment—which they say is relatively easy to access and administer at low costs—can be used to reduce demands on health care systems.Pfizer and BioNTech’s COVID-19 vaccine appears effective against a key mutation found in new variants of the virus discovered in the United Kingdom and South Africa, according to a not yet peer-reviewed laboratory study conducted by Pfizer and the University of Texas Medical Branch. The study tested the vaccine against the N501Y spike protein mutation found in both new variants of COVID-19, which could be responsible for greater virus transmissibility. Blood samples from individuals who have received the vaccine indicated it is effective against the mutation—along with 15 other mutations the company has previously tested the vaccine against—but the findings remain limited, as the study has yet to address the full set of mutations found in either of the new variants. Researchers plan to continue running tests against other mutations found in both variants and hope to have more data in upcoming weeks.

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.

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.Last Wednesday, the United Kingdom authorized AstraZeneca and the University of Oxford’s COVID-19 vaccine, giving the candidate its first regulatory greenlight and providing the country with its second vaccination option. The two-dose AstraZeneca/Oxford vaccine—of which a two-dose, full-strength regimen showed 62 percent efficacy in clinical trials—is low cost and easy to handle, as it can be stored in refrigerators rather than ultra-cold or freezer temperatures that other vaccines require. The United Kingdom has also updated its distribution strategy and will allocate the first vaccine dose of both vaccines to as many people as possible before circling back within 12 weeks, rather than 3, to provide the second dose, instead of holding large amounts in reserve for the second shot. By providing more people with quicker access to the first dose, the hope is to enable the greatest number of eligible people to receive some level of protection in the shortest time possible. Rollout of the AstraZeneca/Oxford vaccine in the United Kingdom begins today.The World Health Organization (WHO) on Thursday issued an emergency use validation for Pfizer and BioNTech’s COVID-19 vaccine, the first COVID-19 vaccine authorization the agency has made. The emergency validation allows some countries to expedite their own regulatory approval processes for the candidate, as well as allows UNICEF and the Pan-American Health Organization to acquire and deliver the vaccine to countries in need. In its statement, WHO also emphasized the need for equitable global access to COVID-19 vaccines and urged a global effort to ensure enough vaccine supply for priority populations around the world. The two-dose Pfizer/BioNTech vaccine, which was shown to have 95 percent efficacy in clinical trials, requires a strict cold chain that could pose a challenge to distribution in many countries.The US Food and Drug Administration (FDA) has approved Ridgeback Biotherapeutics’ Ebanga drug to treat Ebola. The endorsement makes Ebanga the second FDA-approved Ebola therapeutic, following approval of Regeneron’s Inmazeb in October. The two treatments, both antibody therapies, were tested in a trial conducted during the 2018-19 Ebola outbreak in Democratic Republic of the Congo against standard-of-care therapies Zmapp and remdesivir for the control arm. Trial data indicated patients who received Ebanga were more likely to survive than those in the control group. Among those receiving the treatment, 35.1 percent died compared to 49.4 percent in the control group. The 11th and most recent Ebola outbreak in the Democratic Republic of the Congo was identified in June and declared over in mid-November.