Breakthroughs Blog: Pandemic preparedness

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 US Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, has awarded $176 million to Moderna to support the continued development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concerns about the spread of bird flu cases in dairy cows across the United States continue to rise. Moderna's bird flu vaccine candidate is in very early-stage testing and uses the same mRNA technology as its COVID-19 vaccine. The new funding could support a late-stage trial of the vaccine candidate as early as next year if early study results continue to be positive. The vaccine could also be quickly redirected to target another form of influenza if a different threat emerges.A research team has developed a test that will help measure the persistence of HIV in people affected by viral strains found predominantly in Africa, which are greatly understudied, helping to fill a major gap in HIV research. Most HIV studies have focused on the strains circulating in Western countries, predominantly by men who have sex with men affected by subtype B, with much fewer studies examining strains circulating in Africa, where women are disproportionately affected. The new laboratory test allows researchers to determine whether following antiretroviral treatment there is any intact viral DNA capable of producing new viruses if antiretroviral treatment is interrupted. The test is already being used to study long-term viral persistence in Uganda and could be a vital tool in the search for an HIV cure that could target and eliminate this intact DNA reservoir.Last week, the US National Institutes of Health (NIH) announced the launch of a Phase 1 trial testing a nasal vaccine against COVID-19, the first trial conducted by NIH’s National Institute for Allergy and Infectious Diseases as part of Project NextGen, a US government initiative designed to advance the development of next-generation COVID-19 vaccines. In preclinical nonhuman primate studies, the candidate, MPV/S-2P, elicited a strong systemic immune response, as well as mucosal immunity, which plays an important role in controlling respiratory virus replication. Next-generation vaccines, including nasal vaccines, are a key tool needed to reduce COVID-19 infections and transmission as new variants of the virus continue to emerge.

Last week, rain clouds gathered over Geneva as delegates from all over the world completed their annual pilgrimage to the World Health Assembly (WHA), the World Health Organization’s (WHO’s) annual forum for the 194 member states. The somber background reflected the mood heading into the meeting, as many were expecting this year’s gathering to be a washout. A visibly weary WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed his disappointment on the opening day that negotiations on a pandemic accord had not been completed in time for a WHA vote. Representatives also expected contentious fights over sexual and reproductive health and geopolitical conflicts, such as the ones in Ukraine and Gaza, to spill over into the proceedings, freezing debate and derailing possible progress on agenda items ranging from climate and health to universal health coverage. Yet, despite some serious bumps in the road, WHA also showcased that any multilateral system obituary is premature and that multilateralism can still deliver the necessary change we need to advance the global health agenda.   WHA approves new IHR amendments, resets timeline for pandemic agreement negotiationsAll eyes were on whether member states could come together to finalize the negotiations around the pandemic accord, a proposed convention to address some of the shortcomings exposed during the COVID-19 pandemic, as well as amendments to the International Health Regulations (IHR), an existing framework that codifies member state and WHO responsibilities in preparing for and responding to a public health emergency.  Heading into WHA, many stakeholders waited with bated breath to see if member states could bring both these processes across the finish line. Unfortunately, despite two long years of grueling negotiations, countries were unable to forge sufficient consensus to approve the pandemic accord. Instead, countries agreed to extend the mandate of the intergovernmental negotiating body, which coordinates the deliberation process for another year, providing additional time to reach compromises around the most contentious issues (financing, technology transfer—the process by which knowledge is transferred from the originator of a technology to other manufacturers to support the diffusion of health technologies into additional markets—, and a proposed access- and benefit-sharing system, which would pair commitments by countries around the sharing of pathogen samples and sequencing data with commitments from manufacturers to set aside a dedicated portion of their products for equitable distribution during health emergencies).  Nonetheless, member states notched a desperately needed win in reaching consensus on amendments to the IHR, achieving an agreement in the final hours of WHA. The consensus takes on added significance given that country representatives were not only in a race against time but also against fast-eroding trust in multilateralism, which was deeply fractured by the pandemic and subsequent geopolitical conflicts. The amendments to these technical rules, last revised in 2005 following the SARS outbreak, represent the first significant change in international law in the aftermath of the COVID-19 pandemic. While there were many changes to the IHR, one that stands out the most is that the added provisions include a commitment to solidarity and equity on strengthening access to medical products and to financing, including specific text that directs countries to promote research and development (R&D) and strengthen local production of quality, safe, and effective relevant health products. The previous IHR did not include any mention of R&D or the need to ensure equitable access to new tools.   WHA reinvigorates maternal and child health agenda  Progress was also made on a couple of other fronts in Geneva. Alarmed by the stagnation of progress in reducing maternal and child mortality, member states passed a critical resolution committing to specific actions to prevent the deaths of women, babies, and children.The resolution, led by Somalia and other cosponsors, commits countries to tackle the leading causes of maternal and child deaths, particularly in the hardest-hit nations. In it, countries agreed to improve access to maternal health services, including sexual and reproductive services, and comprehensive child health services through stronger primary health care and expanded access to emergency services. It also urges countries to develop and invest in tools that enable access to essential quality medicines for pregnant women, lactating women, mothers, and newborns and calls on WHO to strengthen and expand collaborative efforts, such as those promoted by WHO technical departments and the Global Accelerator for Pediatric formulations, or GAP-f, network, for facilitating better access to medicines for children. The WHA resolution marks WHO’s first significant action on maternal mortality in nearly a decade, following the adoption of the Global Strategy for Women’s, Children’s and Adolescents’ Health in 2015. Antimicrobial resistance in the spotlight  Antimicrobial resistance (AMR) also was in the spotlight in Geneva. With the United Nations High-Level Meeting (UN HLM) on AMR taking place in New York in September and a high-level ministerial meeting in Saudi Arabia in November, this year has been supercharged with attention on the issue, with WHA featuring numerous AMR events, roundtables, and initiatives.  Delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the meetings in the fall. The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, which include prevention of infections; universal access to affordable, quality diagnosis and appropriate treatment of infections; strategic information, science and innovation; and effective governance and financing of the human health sector response to AMR.  The resolution also calls on member states to support investments in R&D for new tools to combat AMR and replenish the shockingly waning pipeline, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System, or GLASS.While WHA did ultimately feature some contentious moments, especially around the geopolitics of Ukraine and Gaza, and major pushback on sexual and reproductive health, the latter almost derailing the adoption of several key decisions, the wins on IHR, maternal and child health, and AMR will have reverberations beyond WHA. Delegates hope that these wins will provide the necessary momentum to continue to make progress on the pandemic accord and at the UN HLM on AMR in the fall.  

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. In a new study, researchers from the Baylor College of Medicine and partner institutions found that a novel, nonhormonal sperm-specific approach showed promise in mice as a reversible male contraception option. The researchers identified a small molecule that would inhibit a key protein, STK33, required for fertility in both mice and human males and generated modified versions of STK33 inhibitors to make them more stable, potent, and selective, eventually testing the most effective compound they generated in mice. The researchers hope to further evaluate the inhibitor and similar compounds to determine effectiveness as a potential contraception option. There has been research into a variety of different strategies for male contraception, but there are currently no approved options for men beyond male condoms.Tens of thousands of genetically modified mosquitoes have been released in Djibouti to stop the spread of Anopheles stephensi mosquitoes that transmit malaria as part of the pilot phase of a partnership between Oxitec, the government of Djibouti, and Association Mutualis. The modified mosquitoes carry a gene that kills female offspring, the only mosquitoes that bite and transmit malaria, before they can reach maturity. If successful, the modified mosquitoes will be tested in larger field trials, and operational deployment will continue through next year, hopefully boosting malaria control efforts. This partnership is the first time that modified mosquitoes have been released in East Africa and the second time on the African continent, although similar technology has been successfully used in Brazil, the Cayman Islands, Panama, and India, with more than one million modified mosquitoes released around the world since 2019.The Administration for Strategic Preparedness and Response at the US Department of Health and Human Services is moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine, as the current outbreak's second human case in the United States was identified this week. The two vaccine candidates are currently in bulk form, with one of the two candidate vaccine viruses reportedly well-matched to the currently circulating strain. Health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish, which will take a couple of months to complete. Agency officials are also coordinating with mRNA vaccine makers Pfizer and Moderna about their potential involvement in vaccine development. There are additional ongoing interagency discussions about what would trigger vaccine deployment, including a change in transmission propensity, like human-to-human or animal-to-human spread; any sign of increased illness severity; a change in the complexion of the cases, like a human infection with no tie to the affected dairy farms; or the identification of a mutation in the virus.

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 week, the Global Health Innovative Technology (GHIT) Fund awarded a two-year grant to the Drugs for Neglected Diseases initiative (DNDi) and its partner Mitsubishi Tanabe Pharma Corporation to continue lead optimization work on a novel compound to target the Trypanosoma cruzi parasite that causes Chagas disease, a neglected parasitic disease that affects an estimated 6 million people globally every year. Current treatments for Chagas, which were developed decades ago, need to be administered for eight weeks, can have serious and potentially toxic side effects, and have not been proven effective in people with severe chronic symptoms. The partners hope their work will lead to preclinical development candidate compounds and, eventually, a new medicine for Chagas disease that is safe and effective for all patients, including pregnant individuals.Researchers have developed an experimental vaccine that has the potential to protect against a broad range of coronaviruses, including known and as-of-yet-unknown varieties. The experimental vaccine was made by taking harmless proteins shared across different coronaviruses and attaching them to minuscule nanoparticles that are then injected to prime the body’s immune system to broadly target both known and unknown viruses in the same family. The vaccine induced a broad immune response to coronaviruses in mice, including to the pathogen that caused the 2003 Sars outbreak, even though proteins from that virus were not added to the vaccine. If proven safe and effective in humans, this and other proactive vaccines designed to target separate pathogens could be stockpiled by countries along with clear plans to quickly scale up production if a new pandemic-potential pathogen emerges. The universal vaccine can be made in existing facilities for microbial fermentation, and the researchers are already working with industrial partners on how to scale up production. There would need to be new processes designed with medical regulators before approval because there are no current procedures for the regulation of proactive vaccinology.Last Monday, the Biomedical Advanced Research and Development Authority announced the launch of the next generation of its accelerator network, which will include a diagnostics and medical devices program and a therapeutics hub. The former will be called the International Consortium for Research, Engineering, Acceleration of Technology Excellence and will support the development and acceleration of new diagnostics and medical devices aimed at improving health security. Along with three more hubs expected to be announced later this year, these hubs will create a global network to foster the growth of the health security innovation ecosystem, including support across the entire process, from development and evaluation to validation and commercialization of new technologies.