Research Roundup: Pfizer vaccine authorized for adolescents, global vaccine task force plans to jump-start manufacturing, and early results from trial on mixing vaccine doses

On Monday, the 74th World Health Assembly (WHA) will kick off and take place virtually for the second year in a row, exhibiting the largest agenda ever with more than 72 items. While the COVID-19 pandemic will once again feature quite heavily, there will also be plenty of time spent discussing necessary broader reforms to the global health architecture, as well as more traditional agenda items. As global health experts gather online and weigh in on the plethora of topics being discussed, here are the top five things the Global Health Technologies Coalition is watching over the course of this year’s forum:1. Ongoing COVID-19 pandemicUnsurprisingly, COVID-19 will remain front and center during the Assembly this year. This year’s forum will come on the heels of the G20 Global Health Summit, which will focus on immediate global response needs, including funding for the Access to COVID-19 Tools Accelerator (ACT-A) and closing gaps in equitable access to health technologies in low- and middle-income countries (LMICs), as well as longer-term reform efforts to bolster the global health security architecture, from strengthening the World Health Organization’s (WHO) mandate and ensuring sustainable funding, to advancing new mechanisms to deal with supply chain and manufacturing bottlenecks.It will be interesting to see how the debate around WHO’s coordinating role as part of ACT-A is discussed, whether member states take the opportunity to provide further financial commitments to COVAX and other multilateral entities, and what additional steps WHO will outline for providing technical support to member states as part the broader discussion on this topic.2. WHO reform and changes to the global pandemic preparedness architectureHeading into the Assembly, a number of review processes, including the International Health Regulations (IHR) review committee as well as the Independent Panel for Pandemic Preparedness and Response (IPPPR), provided their assessment of how WHO and member states responded to the pandemic, how current systems are falling short, and what key systemic changes need to be made to ensure the world is never again caught unprepared.In particular, the IPPPR call for advancing a Pandemic Framework Convention (more commonly referred to as pandemic treaty) within the next six months that would be complementary to the IHR, using the powers under Article 19 of the WHO Constitution, will be something to watch. First floated by European Council President Charles Michel in November, the idea has so far been backed by 25 countries as well as WHO. While current efforts are still a bit disjointed and lack detail, the Assembly could serve as the forum to help set the parameters and start the deliberations on the mechanisms that need to be integrated. This includes a new research and development (R&D) coordinating mechanism, as was suggested in the recent IHR review panel report recommendations. It is notable that the United States, while open to considering the treaty proposal principle, is looking to slow the process and ensure that there is broad consensus around some of the key principles being discussed. There is likely also going to be a discussion about the future of ACT-A, especially whether the model can be carried forward beyond COVID-19 and what lessons can be learned from the past year on how the process was developed and operated. The IPPPR highlighted the need for a pre-established platform that helps coordinate and accelerate the development, delivery, and uptake of vaccines, therapeutics, diagnostics, and essential supplies for emerging infectious diseases, looking at end-to-end product development and ensuring equitable access for all populations. The IPPPR did not specify what the model should be however, leaving some flexibility on whether it is simply an evolution of ACT-A or a new platform entirely. Either way, this debate should be an important one as the global health community looks for ways to pivot beyond the current crisis and also ensure that systems being constructed and reformed could have a reverberating impact beyond pandemic preparedness including through strengthening research capacity to fight a broad range of poverty-related and neglected diseases.3. Intellectual property, access, and strengthening local manufacturing capacityIssues around access and intellectual property (IP) have been hot-button topics for years, with discussion of IP rights, transparency of R&D costs, and technology transfer being contested by member states and civil society. This year though, the dialogue is shifting around the need for global common goods for COVID-19, and the recent surprising announcement by the Biden administration in support of India and South Africa’s proposal to waive IP rights for COVID-19 vaccines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) highlights the seismic shift in the dynamics on this issue. While it is unclear whether this will lead to concrete commitments, the dialogue around what is possible is evolving, and we will tune into any decisions or resolution that could come out of WHA.  There is also likely going to be a resolution focused on strengthening local production of medicines and other health technologies to improve access. The resolution brings to the fore a key issue that emerged in the first months of the pandemic when the globalized and highly concentrated global supply chains for critical medicines were interrupted—from antimalarials in some parts of Africa to certain common antibiotics in Europe. The resolution is likely to reaffirm and complement other key initiatives that are in the works around strengthening manufacturing capacity in LMICs, including the recent partnership announcement between the Coalition for Epidemic Preparedness Innovations and the African Union.4. Refocusing on health areas disrupted by the pandemicThere will be a strong push to discuss topics that have taken a back seat to the immediate pandemic and have a return to (or close to) business as usual at this year’s Assembly. From an R&D perspective, agenda items focused on Immunization Agenda 2030 (IA2030) and antimicrobial resistance will also be front and center. This is significant as we have seen routine immunization campaigns and clinical trials being stalled during the pandemic, and disrupted immunization services and supply chains have left millions at risk and widened inequities. Member states will discuss the implementation of the newly adopted IA2030 and outline operationalizing the strategy. Member states and advocates are likely to highlight the need for additional technical support for countries as well as clear accountability metrics to be considered as part of the initiative.There will also be updates and revisions to existing strategies, including WHO’s Global Technical Strategy for Malaria. The United States and Zambia are working on a draft that would highlight the need to reinvest to counter the backsliding on the progress made and strengthen service delivery, particularly for marginalized communities.5. Civil society engagement 2.0 Over the past year, civil society has lamented the diminished role and engagement it has had in major WHO meetings, especially at the Executive Board meeting and WHA. WHO decided to try to recalibrate the way non-state actors (NSAs) participate in these fora, by creating a three-day consultation summit held with NSAs a few weeks ago and changing some of the processes for engagement at the Assembly itself. While the consultation forum provided a new platform for some organizations to engage more in depth with the WHO Secretariat, member state participation was low, and it remains unclear how the feedback shared on various agenda items will be considered in the deliberations of resolutions and draft decisions being crafted by officials in the weeks leading up to the Assembly. Civil society organizations are also displeased and concerned with the continued efforts to push NSAs to make statements as constituencies and to group agenda items together, leading to less targeted and technical interventions from civil society groups. WHO is nevertheless plowing ahead with this concept, piloting this new process this year. Coming out of the forum, many organizations will likely try to provide very blunt feedback on the direction that WHO has taken and push for more meaningful mechanisms for NSAs to contribute to important discussions.

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 US government announced it would support a proposal to temporarily waive intellectual property rights for COVID-19 vaccines. The proposal, first introduced to the World Trade Organization (WTO) last fall by South Africa and India, would cover patents, industrial designs, copyrights, and protection of trade secrets, ultimately making it easier for countries that permit compulsory licensing to allow a manufacturer to export vaccines. In order to pass, the proposal would need support from all WTO members, and the measure is still opposed by a number of high-income countries. Following the US statement, however, several countries announced they are open to discussing the proposal. A decision on whether to grant the waiver is expected next month.An existing, cheap therapy could have potential as a long-acting injectable treatment for COVID-19, according to a recent preclinical study by researchers at the University of Liverpool. The data showed niclosamide, a therapy used to treat tapeworm infestations, to be highly effective against the SARS-CoV-2 virus in multiple laboratory studies. The researchers formed dispersible solid drug nanoparticle formulations of niclosamide that can be stored as solids, reconstituted with water, and then utilized as a long-acting injectable. The research team is looking to move the therapy into human trials and is working with a contract manufacturing organization toward scale up and clinical manufacturing.The Moderna COVID-19 vaccine was 96 percent effective in preventing illness in adolescents aged 12 to 17, according to early data released by the company Thursday. The vaccine was also generally well tolerated, and the majority of adverse events were mild or moderate, according to the statement. The analysis, which came from a study of the vaccine among 3,235 participants in the United States, identified no serious safety concerns. Moderna said it is in discussions with regulators about a potential amendment to expand its regulatory authorization to this younger age group. It is currently authorized for people aged 18 and over in countries where it has been approved.