Research Roundup: Generic Paxlovid, Ebola Zaire vaccines, Innovative HIV vaccine

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 AMR Action Fund has announced its second investment, this one of $US7.5 million in European biotech company BioVerys, which is developing an antibiotic (about to enter phase 2 trials), to combat hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections originating from pneumonia. The investment underlines the fund’s role in filling massive gaps in the need for new antibiotics to address the growing challenge of antimicrobial resistance (AMR). The fund, which was created by several of the world’s largest drug companies, works as a venture capital fund with the goal of generating four new antibiotics over ten years. It first invested last year in two small American biotech companies also working towards therapies that can address drug-resistant infections.The Pan American Health Organization has confirmed that vaccine-derived poliovirus type 2 has been detected in wastewater samples in Canada, joining the United States, the United Kingdom and Israel as high-income countries that have detected the virus in wastewater. The Canadian National Microbiology Laboratory, which detected the virus through retrospective wastewater tests, will test archived samples from September and October 2022 through the end of February 2023 to obtain more details about the spread of the virus. This news comes as a reminder that as we enter 2023, new polioviruses, including vaccine-derived poliovirus type 2, continue to emerge around the world.In the midst of China’s severe COVID-19 outbreak, the World Health Organization’s (WHO’s) Director General Dr. Tedros Adhanom Ghebreyesus is expressing concern about possible underreporting and underrepresenting of data, and urging the country to use all available COVID-19 vaccines, including mRNA vaccines that have been shown to be more effective than Chinese-made COVID-19 vaccines. This concern comes following the release of a report by WHO’s Technical Advisory Group on Virus Evolution that found, through working with the Chinese Center for Disease Control and Prevention, there have been no new variants circulating in the country. Full and transparent data sharing on cases, deaths, hospitalizations, and comprehensive, real-time viral sequencing are essential for WHO’s efforts to carry out risk assessments for China and around the world, as well as to understand the evolution of SARS-CoV-2 and the emergence of mutations of variants of concern.

On Friday, President Joe Biden signed into law a US$1.7 trillion spending bill that will fund the US government through fiscal year 2023 (FY23), which ends September 30, 2023. The package includes significant funding increases across nearly every line relevant to global health research and development (R&D), as well as complementary directives that will support global health R&D across several agencies.How it passedUntil mid-December, the outcome of the spending package was still uncertain. Many Republicans in the House and some in the Senate were hoping to see a continuing resolution—a stopgap measure to postpone negotiations—into next year when they would hold more leverage with control of the House. Top House appropriator Rosa DeLauro (D-CT) responded by threatening to only pass a full-year resolution if no progress was made. As talks froze, Democratic lawmakers turned up the tension forcing a breakthrough weekend negotiation in early December. A few more bumps laid in the way, especially in the Senate, where energy permitting reform and Title 42 amendments were set on the table but ultimately shoved away, clearing a last-minute path for passage.New fundingPassage of the bill is mostly great news for global health R&D. Nearly every funding line across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the US Agency for International Development (USAID), and the State Department relevant to the sector has increased. Some notably large increases include:A 10 percent increase for universal influenza vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID).A 50 percent increase for the Advanced Research Projects Agency for Health (ARPA-H).A 10 percent increase for NIH’s Fogarty International Center.A 9 percent increase for CDC.A 7 percent increase for the CDC Center for Global Health.A 9 percent increase for the CDC National Center for Emerging and Zoonotic Infectious Diseases.A 21 percent increase for global tuberculosis programs at CDC.A 16 percent increase for Global Public Health Protection at CDC.A 26 percent increase for BARDA.A 28 percent increase for the Global Fund to Fight AIDS, Tuberculosis and Malaria.A 7 percent increase to USAID global health programs, of which most goes to a 29 percent increase for global health security at USAID.New directivesIn addition to funding, spending bills are passed with corresponding plain-language texts called bill reports. which include directives from Congress. These reports do not hold the same legal power as the spending bills themselves, but they are a way for Congress to urge or direct agencies to change their policies or to spend their funding in specific ways. Nearly all GHTC’s requests for report language to Congress were reflected in the final FY23 package (either through the House bill reports or the joint explanatory statements, for those keeping count). Some notable wins include:Direction for USAID to increase health-related R&D funding and to consult with representatives of affected communities, as well as technical experts and nongovernmental organizations specializing in biomedical product development (House report).General continued support for USAID’s role in health-related R&D (House report).Requirement for USAID to submit a report on its health-related R&D investments (joint explanatory statement; also includes request for details on investment in antibiotic research).Request for an update from the Department of Health and Human Services on coordinating global health research activities using metrics (House report).Recognition of the need to increase resources for NIH’s Fogarty International Center and expand their role in pandemic preparedness and health research capacity-building (House report).Support for CDC’s role in global health security and developing and validating new global health tools (House report).Support for BARDA to provide robust funding for emerging infectious diseases and naturally occurring threats to global health security and to account for the constraints of low-resource settings in the development of new products (joint explanatory statement).Urges BARDA to publicly and regularly report on pathogen-, product-, and project-level data for all its funding (House report and joint explanatory statement).Relevant RidersThis year’s package also included quite a few riders—bills less relevant to funding that were amended onto the omnibus package. Nearly all elements of the PREVENT Pandemics Act were attached, including:Authorization of ARPA-H as a new entity within NIH. Despite its technical placement under NIH, the accompanying report language encourages ARPA-H to be physically and culturally separated. The authorization includes prioritizing awards to entities that conduct their work in the United States (a provision that GHTC has opposed).Establishment of a NIAID-BARDA “multidisciplinary research program with research centers to advance the discovery and preclinical development of antivirals and other medical products to combat priority virus families.”Expansion of the FDA fast-track designation for new antimicrobials that are biologics.The bill also includes several amendments to the US Food and Drug Administration (FDA) that had been dropped from the FDA user fees negotiations earlier this year. These include:Requesting a Government Accountability Office report on nonprofit pharmaceutical organizations, including the “impact of such organizations on the development, availability, and cost of prescription drugs, and any challenges to manufacturing or other operations.”Establishes a pathway for accelerating the review of advanced manufacturing technologies that either combine or incorporate novel technologies or techniques for manufacturing drugs, biologics, or active pharmaceutical ingredients.Requires sponsors of new drugs and devices to submit diversity action plans for clinical trials (exceptions permitting).Requires FDA to convene wide stakeholder meetings to solicit input on “increasing the enrollment of historically underrepresented populations in clinical studies.”Requires FDA to submit a report to Congress on progress for diversity action plans in aggregate.Requires FDA to issue guidance on decentralized clinical studies for drugs and devices and “how to advance the use of flexible and novel clinical trial designs” to increase diversity of participants.Requires FDA to issue guidance on the use of digital health technologies in clinical trials.In summaryDespite the delay, GHTC applauds lawmakers for passing increased funding, smart report language, and riders that will strengthen global health security and medical product regulation. The FY23 omnibus package is a significant win for most global health and global health research programs. Many pundits predict that in the next Congress we are less likely to see similar funding increases given the split control. Regardless, GHTC looks forward to working with offices on both sides of the aisle to advance bipartisan priorities for global health R&D.