Breakthroughs Blog: Pandemic preparedness

With thousands of delegates dashing from one meeting to another in the frenetic New York streets, it was clear that the United Nations General Assembly (UNGA) was back in full swing this year. Given the three High-Level Meetings (HLMs) on global health, including pandemic preparedness, prevention, and response (PPPR); universal health coverage (UHC); and tuberculosis (TB), this was already set to be a major opportunity to reset coming out of the worst of the COVID-19 pandemic. Yet despite high ambitions, this year’s forum fell short of expectations, with many key issues, such as new agreements for sharing medical countermeasures (MCMs), accountability and enforcement mechanisms, or new funding commitments, being either punted to other forums or ignored. Innovation did feature strongly in all three HLMs, and despite the general disappointment, the research community was able to notch a few wins.A milestone in global pandemic preparednessThe UNGA HLM on PPPR marked a historic moment with the adoption of a political declaration. While nonbinding, this declaration carries significant symbolic weight, underscoring the global recognition that pandemic threats transcend mere health emergencies; they are existential threats that must be addressed with a whole-of-society approach. However, it was clear in the lead-up that the ambition had been severely curtailed and much of the text of the political declaration watered down. The meeting saw minimal participation from heads of state and inadequate representation from civil society. Many countries chose to focus on their past accomplishments in PPPR without articulating clear next steps or new commitments.Funding (or lack thereof) was another key theme of the week. The declaration emphasizes the importance of supporting sustainable and alternative financing mechanisms, as well as strengthening the capacity for innovation and production of MCMs. Specifically, it highlights the need to assist low- and middle-income countries (LMICs) by bolstering local production, technology transfer, and voluntary licensing. Support for the Pandemic Fund is noted, acknowledging the need for $10 billion to make the mechanism successful. Despite these encouraging commitments, the adopted declaration does not include specific new financial pledges for the Pandemic Fund nor targets that ensure the realization of the 100 Days Mission Plus, an initiative that would seek to develop and distribute MCMs within 100 days of an outbreak. Some were also hoping to see the declaration lay out some key principles or targets for a potential MCMs platform to succeed the Access to COVID-19 Tools Accelerator, which coordinated and oversaw the rollout of COVID-19 technologies to low-income countries. But while leaders emphasized the importance of achieving equitable access to essential tools in their statements, disappointingly, there was no mention of a platform in the final declaration text, and the idea was hardly mentioned by member states during debate. Instead, it was clear from the statements leaders made at the meeting that they are eyeing the ongoing processes in Geneva on a pandemic accord and reforms to the International Health Regulations (IHR) to resolve many of these issues—further increasing the stakes for the outcomes of these processes, which need to be aligned with each other and with the declaration.Lack of progress on UHC implementationThe UHC meeting began with the adoption of a nonbinding political declaration by member states. During the meeting, issues of equity and access took center stage. Various countries emphasized the importance of ensuring that health care and health products are accessible to all, regardless of income, and advocated for gender-inclusive health interventions.The role of R&D in achieving UHC emerged as another central theme. Many countries highlighted the need for local and regional production of vaccines, diagnostics, medicines, and other health technologies. Several member states stressed the importance of technology transfer to LMICs and the removal of barriers posed by intellectual property rights. Collaboration and innovation were identified as key drivers of improved global health outcomes. In alignment with the sentiments coming out of the previous day’s PPPR HLM, this reflects a growing recognition of the importance of regional and domestic capacity for health care production and innovation.The spotlight on R&D in the broader UHC context is an exciting step in the right direction, but like the PPPR HLM, the UHC discussions lacked targeted commitments. Member states focused on identifying gaps and areas of needed improvement, such as localized manufacturing of health technologies and increased investments, but largely failed to pledge new financing and other concrete commitments to fill these gaps.  TB commitments finally include tangible targetsThe week culminated with the TB HLM adopting a political declaration, setting forth targets and commitments for tackling TB. In the document, governments pledged to mobilize at least $22 billion annually by 2027, with a more substantial commitment of $35 billion annually by 2030 for TB prevention and treatment. Additionally, there was a commitment to mobilize an additional $5 billion a year by 2027 for TB research and innovation. These commitments are ambitious, especially given that governments have delivered less than half of the $13 billion they had committed to raise by 2022 during the 2018 HLM. Similarly, only half of the $2 billion pledged annually for TB R&D has materialized.While many in the TB community celebrated the adoption of the declaration, it is important to note that the document does not go as far as some advocates would have liked, particularly on equity and inclusiveness provisions, and others have expressed disappointment about the lack of engagement from heads of state. That said, the ambitious funding targets set forth in the declaration hold the potential to make a significant impact if they are met with concrete actions, accountability, and global leadership. Now, the challenge lies in holding governments accountable for their commitments by putting in place robust monitoring mechanisms to track progress.So where do we go from here? With all three political declarations adopted at the HLMs, the General Assembly must formally ratify them in the coming week, and there could still be fights ahead, as several member states lodged objections ahead of the summit. The UNGA HLMs shed light on the global community's priorities on PPPR, UHC, and TB but also gave insight on the lack of concrete commitments from member states. Heads of state were disappointingly underrepresented in all three. Statements from ministers were verbose on gaps and needs but short on commitments and implementation.Zooming out to the broader ecosystem, it is reassuring to see alignment between multilateral bodies, such as the G7’s promise to foster innovative technologies for TB and other diseases, acknowledging the need for advancements in this critical area. In fact, one of the major concrete announcements of the week was the government of Japan launching its Impact Investment Initiative for Global Health (Triple I for GH), a new G7 initiative that seeks to align private and nonprofit stakeholders around best practices for impact investment in global health. Finally, the G20 also reaffirmed its commitment to combat TB and other diseases and to support the interim MCMs platform under development by WHO.While the HLMs were significant milestones, the true test lies in the implementation of commitments. With the political declarations being nonbinding, it is now up to other multilateral bodies to pick up the baton and ensure targets are established, commitments are made, and leaders deliver on implementation. Looking ahead, the deliberations around the pandemic accord will next take center stage through the intergovernmental negotiating body on the pandemic accord, with the process set to conclude by next year. Several member states hope this will serve as a vehicle to advance discussions on the development and access to MCMs. Similarly, IHR reforms offer a chance to advance key elements of the PPPR agenda, such as data sharing and other core capacities.  The G7 and G20 will also need to play a bigger role in financing all these ambitions.The HLMs ultimately served as a good reset moment to reemphasize the importance of these global health priorities, but it is now up to other forums and national governments to work collaboratively to translate pledges into action.

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 Food and Drug Administration (FDA) has given 510(k) clearance to the BD Respiratory Viral Panel, an automated, multiplexed, and real-time PCR test that can be used to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) from only one sample, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA). The panel runs on a BD system widely used by hospitals and labs across the United States that can process hundreds of samples a day and deliver results in two hours. By reducing the need for multiple tests to distinguish the cause of respiratory infections, the test will help patients receive appropriate care faster and reduce burdens on the health system, which is important as the United States faces the rising threat of these viruses over the coming months.FDA is expected shortly to approve updated versions of the COVID-19 boosters, which although originally designed to target the XBB.1.5. omicron subvariant should still protect against the currently circulating subvariants, as cases and hospitalizations linked to the new variants rise. While it remains unclear whether the agency will grant emergency use authorizations or full approval licenses, either will trigger the Centers for Disease Control and Prevention to make its recommendations for who should receive the shots, allowing vaccinations to likely begin soon in the United States.Ghana recently became the first country in Africa to manufacture a cholera vaccine. The private-sector pharmaceutical consortium DEK Vaccines Limited produced the vaccine, as well as six others, including against malaria, HPV, pneumonia, and rotavirus, which are expected to be available by 2026. This was made possible through a licensing and technology transfer agreement with the International Vaccine Institute (IVI). Scaling up local production of vaccines is seen as an important step toward enabling Ghana, the West African region, and the continent at large to reduce the critical shortage of vaccines and reliance on foreign countries and companies and to ensure greater access to vaccines that protect against endemic 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 World Health Organization (WHO) last week announced its first COVID-19 vaccine license agreement through the COVID-19 Technology Access Pool (C-TAP) with Taiwanese manufacturer Medigen Vaccine Biologics Corp. The vaccine license was acquired through the Medicines Patent Pool, which also enabled last week additional agreements under C-TAP for a COVID-19 vaccine prototype and a test used to measure COVID-19 antibody levels. While C-TAP was launched at the height of the pandemic to promote technology sharing to improve access, particularly to vaccines, in low-income countries, major pharmaceutical companies have thus far declined to join the initiative.A clinical trial led by researchers at St George’s, University of London found that a higher dose of the antibiotic rifampicin for an abbreviated four-month treatment regimen for tuberculous (TB) was safe with no increases in side effects or toxicities, compared to the standard six months, which is WHO-recommended. The trial took place among adults with newly diagnosed pulmonary tuberculosis in Uganda, Guinea, Peru, Nepal, Botswana, and Pakistan. Experts say shorter treatment regimens will help lower costs and increase patient compliance, which will in turn reduce transmission and the development of resistance to available TB drugs. CSL Sequiris announced that it received an award from the Biomedical Advanced Research and Development Authority (BARDA) to deliver a vaccine for bird flu to the US government, increasing BARDA’s stockpile in case of an outbreak. The company will deliver one bulk lot of the H5N8 A/Astrakhan antigen to the US government, whose development has been supported by BARDA in recent years. The agreement is intended to improve US national vaccine preparedness and is especially significant as bird flu continues to be detected around the world, including a small number of human cases.

The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned!