Research Roundup: Pfizer cold storage requirements relaxed, Sanofi/GSK vaccine shows promise in phase 2, and US commits to share vaccine doses

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, UNICEF signed an agreement with Human Vaccine, a subsidiary of the Russian Direct Investment Fund, for supply of up to 220 million doses of the Sputnik V COVID-19 vaccine. Procurement of the doses will be contingent on the vaccine receiving emergency use listing from the World Health Organization (WHO) and an advance purchase agreement with Gavi, the Vaccine Alliance, for the COVAX vaccine-sharing facility. The organizations leading COVAX also made an announcement last week renewing the call for funding and vaccine sharing, urging countries to share at least 1 billion doses in 2021. COVAX has so far delivered more than 70 million doses to 126 countries and economies since February, but it will face a shortfall of 190 million doses by the end of June, according to the statement.The US Food and Drug Administration on Wednesday authorized a new monoclonal antibody therapy for patients ages 12 and older with mild-to-moderate COVID-19 who are at high risk for infection. Sotrovimab, developed by GlaxoSmithKline (GSK) and Vir Biotechnology, reduced risk of hospitalization or death due to COVID-19 by 85 percent in a study of 583 volunteers who had begun experiencing symptoms within the previous five days. It was also shown in laboratory tests to be able to neutralize the virus variants first identified in the United Kingdom, South Africa, Brazil, California, New York, and India. The US government has not announced plans to purchase the drug, but the companies expect the drug to become available in the United States in the coming weeks, according to the GSK news release.Two COVID-19 vaccines made by Sinopharm appear safe and effective, according to results published in the Journal of the American Medical Association. The report indicated that the two vaccines, one developed by the Wuhan Institute of Biological Products and the other by the Beijing Institute of Biological Products, are 73 and 78 percent effective, based on a trial involving approximately 40,380 participants. Follow-up data is continuing to be collected at additional study sites in Egypt and Jordan. The numbers are consistent with results Sinopharm had previously reported in interim analyses. WHO cleared the Beijing Institute of Biological Products’ vaccine for emergency use in early May, and both vaccines have already been distributed and administered globally.

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.