Research Roundup: AstraZeneca shot gets first authorization, WHO issues emergency validation for Pfizer vaccine, and second Ebola drug gets FDA approval

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. On Friday, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.The US National Institutes of Health (NIH) is sponsoring two phase 3 clinical trials investigating monoclonal antibodies as treatment for hospitalized COVID-19 patients with moderate illness. The trials are sub-studies of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program, an adaptive trial designed to investigate new therapeutics as they become available. One of the treatments, developed by GlaxoSmithKline and Vir Biotechnology, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody with potential to neutralize the virus and kill infected cells. The second treatment, developed by Brii Biosciences, is a combination of two neutralizing monoclonal antibodies. Both trials hope to show treatment efficacy in hospitalized patients, a subset of patients for which monoclonal antibody treatments have so far not shown an impact.The FDA granted EUA last week to the first-of-its-kind rapid COVID-19 test that can be conducted fully at home without need for a prescription. The diagnostic, which was developed by Ellume, detects SARS-CoV-2 virus fragments from a nasal swab sample using an analyzer that connects with a smartphone app, providing results in as little as 20 minutes. While less accurate than typical molecular diagnostics, the test has shown a sensitivity of 96 percent and specificity of 100 percent and, in asymptomatic individuals, a sensitivity of 91 percent and specificity of 96 percent. Ellume intends to produce around 3 million tests by next month and 20 million by the second half of 2021 to be accessible in drug stores for over-the-counter use.