Breakthroughs Blog: COVID-19

Next week, the World Health Organization’s (WHO’s) 152nd Executive Board (EB) meetings kick off in Geneva, with delegates and civil society representatives participating in person for the first time in two years. Recent months have seen a shift away from COVID-19 and an increased focus on long-term reforms to the broader global health architecture. While the dialogue around designing global frameworks and new mechanisms to address future health threats is vital, many of the discussions on poverty-related and neglected diseases are seemingly absent from this year’s discourse.  Here are the four issues to watch at this year’s meetings: Continued focus on global health security  2022 was a fruitful year for advancing two processes that will significantly influence the future of pandemic response. First, the intergovernmental negotiating body tasked with shepherding the Pandemic Accord process developed its first conceptual draft for the new framework. This comes following multiple public hearings, member state negotiations, and consultations on specific elements including equity, access and intellectual property, and antimicrobial resistance. Encouragingly, the document includes some strong research and development (R&D) focused language and recognizes R&D as an integral pillar of health preparedness. However, the current draft emphasizes downstream response measures such as manufacturing and registration, with less of a focus on early-stage research, clinical development, and even post-registration access and delivery of health tools. Additional focus on early-stage discovery research, clinical development, regulatory processes, and access and delivery of medical countermeasures is needed to ensure the type of true end-to-end approach critical to global health security. The second major global health security focused process has been centered around targeted amendments to the International Health Regulations. This policy discussion primarily focused on changes to provisions on trade and travel health certificates, as well as data-sharing and reporting requirements. Though perhaps less prominently discussed, disputes over intellectual property, in particular those centered on genetic sequence and pathogen sharing, remain major barriers to consensus. Both of these processes will be debated during EB, and we can expect a concerted effort to clearly delineate these processes and advance dialogues around defining the terminology and scope of both endeavors.  Limited progress on the implementation of the clinical trials resolution Last year, member states passed a resolution on clinical trials with the intent to build on lessons learned from the COVID-19 pandemic. The crisis drove a surge in funding for clinical research on COVID-19 tools, but we also saw many trials that were not large enough or that failed to employ consistent protocols and outcome measurements across geographies, making it difficult to pool and compare data to turn conclusions into medical practice. Among other matters, the resolution urged countries to better coordinate research, standardize protocols, improve reporting on trial registration and results, and work to increase clinical trial capacity globally, particularly in low- and middle-income countries—though none of these actions are binding. It also requested that WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at this year's assembly.EB will provide a chance to level set the current status of the implementation of the clinical trials resolution and figure out which elements of the framework could be improved. Previous discussions suggest that the current progress in implementing the resolution has been limited. During consultations held last fall, member states highlighted gaps in data on specific population groups and disease targets, as well as gender biases in data, which may result in these groups being precluded from access to needed interventions, as a point of inequity that must be addressed. The public consultation also noted the crucial importance of strengthened national regulatory authorities and national ethics committees, as well as increased international collaboration and coordination for efficient funding of agreed-upon priorities for multinational and multiregional trials, where appropriate.  The EB now has a chance to build on the progress and push WHO to follow through on their global action plan and for member states to support mechanisms like the WHO International Clinical Trial Registry Platform to push this agenda forward.  A new resolution on diagnostics could be passed New on the docket this year is a resolution that focuses on the development of—and access to— diagnostics. A recent Lancet report sounded alarm bells, highlighting that almost half of the global population has little or no access to diagnostics. The COVID-19 pandemic has clearly shown that a country’s diagnostic capacity is directly linked to its ability to respond to pandemics with appropriate public health measures and effective monitoring of emerging variants. Given the depth of the challenge, sustained access to quality, affordable diagnostics will require multi-decade prioritization, commitment, and investment.  This resolution is a good first step in acknowledging the need for more political will in addressing the diagnostics gap. Notably, it urges member states to develop a National Essential Diagnostics List, adapting the WHO Model List of essential in vitro diagnostics and the WHO List of Priority Medical Devices. The resolution further urges countries to invest in R&D, expanding manufacturing capacity for diagnostic medical devices and surveillance and strengthening international collaboration and assistance during epidemics and pandemics.  The resolution also calls on WHO to support member states to strengthen national and regional regulatory systems for diagnostic medical devices, collect data on the affordability and availability of essential diagnostic medical devices, and consider and support mechanisms for procurement that will enable access to high-quality, affordable diagnostic technologies for all member states. Some hurdles to approving this resolution remain, including outstanding disagreements on whether to include provisions pertaining to intellectual property and access, but there appears to be broad support from member states to get this resolution across the finish line in Geneva.  UHC back in the spotlight Universal health coverage (UHC) is also back in focus for this year’s EB, especially with September 2023 marking the halfway point of the timeline to reach the Sustainable Development Goals (SDGs) and leaders preparing for a United Nations High-Level Meeting on them at this year’s General Assembly. While some progress toward the SDGs has been made, the COVID-19 pandemic caused major disruptions in both health services and the development of health system capacities globally.  From a research perspective, a report by WHO ahead of EB highlighted that research and innovation continues to play a crucial role in UHC. Inequitable access to medical products is among the main causes of financial hardship in many lower- and middle-income countries. The report also notes how the recent World AIDS Day 2022 campaign highlighted the dangers of these inequalities, calling on global leaders and citizens to equalize access to essential HIV services, particularly for children and key populations, in order to end AIDS as a public health threat.  EB is a chance to hit reset on the UHC dialogue and for countries to reaffirm their commitment to the SDGs. It is also an opportunity to reassert that health system strengthening supports all health areas, including pandemic preparedness and poverty-related and neglected diseases. It is vital that leaders break down silos and take a more holistic approach to ensure progress toward advancing the global development agenda and 2030 targets. As discussions on global health architecture reforms advance, and new investments in pandemic preparedness are made, it is vital that global decision-makers ensure the benefits of these resources are also leveraged to benefit the fights against tuberculosis, HIV, malaria, and neglected tropical diseases. 

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 Coalition for Epidemic Preparedness Innovations (CEPI) last week announced US$2 million in funding for American pharmaceutical company, Tiba Biotech, which has developed promising RNA technology that could make the development of mRNA vaccines targeting Disease X (a pathogen with pandemic-potential that has yet to be identified) cheaper, more effective, and more tolerable. While mRNA vaccines for COVID-19 have successfully been administered globally, limitations including side effects and ultra-cool cold chain storage requirements hinder their effectiveness and accessibility. This first round of funding will support the development of a vaccine candidate for Japanese encephalitis. If that candidate is successful, this technology could lead to the development of a variety of Disease X vaccine candidates to be included in CEPI’s library of vaccines as part of the 100-day plan to speed up vaccine development and rollout after the emergence of a disease threat.Last week, the World Health Organization’s (WHO’s) Africa Region declared the end of the recent outbreak of Sudan ebolavirus. WHO is expected to convene Ebola experts to discuss how to move forward with the plans to trial three experimental vaccine candidates that target the Sudan strain responsible for the recent outbreak. The trial was aimed at ensuring both study groups received protection from a vaccine (one group after a time delay) and generating data about the potential of these candidates, which is much needed, as there are no approved vaccines targeting Sudan ebolavirus. Finding a new strategy for testing the vaccine candidates will be challenging because the Sudan ebolavirus is rare and with limited cases, and therefore it would be difficult to obtain enough data to prove safety and efficacy, especially for all three candidates. One potential path for continuing the trial is testing efficacy on non-human primates and then more extensive testing of safety and immune response in healthy human volunteers.Last week, the Respiratory Virus & Microbiome Initiative was launched, in collaboration with the UK Health Security Agency and funded by the Wellcome Sanger Institute. The initiative will track the evolution of a variety of respiratory pathogens including SARS-CoV-to improve viral monitoring in the UK and enhance the country’s ability to quickly identify the emergence of new viruses. There is additional hope that this work will ultimately generate much-needed knowledge about the viral families behind common diseases, as well as spur the development of vaccines and therapeutics for these viruses. This initiative comes after the COVID-19 pandemic led to viral sequencing efforts around the world that helped guide responses and detect new variants and led to the development of diagnostics and vaccines.

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.

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 World Health Organization (WHO) recently added Indian company Hetero’s generic version of Paxlovid (Pfizer’s COVID-19 antiviral) to its prequalification list. Hetero also announced a licensing agreement with the Medicines Patent Pool to manufacture and sell the generic version in low- and middle-income countries. WHO’s inclusion will hopefully improve access for the drug, which the agency has strongly recommended for the treatment of high-risk patients with mild and moderate COVID-19, but which has been largely inaccessible to patients in low- and middle-income countries.Recent findings published in the New England Journal of Medicine found that initial results from two phase 2 clinical trials showed that two vaccines (Ad26.ZEBOV (Ad26) followed by MVA-BN-Filo (MVA) 56 days later and rVSVΔG-ZEBOV-GP (rVSV)) given with or without a booster dose 56 days later) against the Zaire strain of Ebola virus are safe and well-tolerated in adults and children. Both vaccines produced antibody responses as soon as two weeks after administration of the first dose that lasted for at least a year. As part of the PREVAC study in West Africa, these trials aim to assess the safety and efficacy of different experimental vaccine regimens for Ebola Zaire vaccines in order to reduce the high mortality associated with Zaire outbreaks.An innovative, new vaccine for HIV developed by the Scripps Research Institute in collaboration with the Fred Hutchinson Cancer Center, the International AIDS Vaccine Initiative, and the US Institute of Allergies and Infectious Diseases, among others, has demonstrated promising results in its first immunogenicity trial in humans. In response to HIV exposure, the vaccine, called eOD-GT8, is designed to induce a type of broadly neutralizing antibodies that can block a specific part of the virus that is needed for it to enter certain cells. While extensive further research and many further challenges remain, the recent results do demonstrate the potential of a complex and innovative approach.