Research Roundup: Vaccines to undergo regulatory review, COVAX releases interim distribution plan, novel HIV vaccine approach shows promise in early trial

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.On Wednesday, a World Health Organization (WHO) panel recommended the use of AstraZeneca and the University of Oxford’s COVID-19 vaccine for all adults over 18. The recommendation is not an official emergency use listing but could pave the way to broader use of the vaccine—including by the COVAX Facility and African Vaccine Acquisition Task Team, both of which have secured hundreds of millions of doses with plans to distribute to participating countries in the coming months. On Thursday, Africa Centers for Disease Control and Prevention (CDC) Director John Nkengasong said his organization was also recommending use of the AstraZeneca/Oxford vaccine, except for in countries where the B1351 COVID-19 variant, first identified in South Africa, has become dominant. Africa CDC made its decision after data from a study in South Africa indicated poor efficacy of the vaccine in preventing mild to moderate illness caused by the variant, while WHO did not make the same specification, noting that the vaccine was still likely to be effective in preventing more severe COVID-19 cases.The US Food and Drug Administration (FDA) on Tuesday granted emergency use authorization (EUA) to Eli Lilly’s combination monoclonal antibody therapy to treat mild to moderate cases of COVID-19 in patients ages 12 and up who are at high risk for progressing to severe disease. The therapeutic, a combination of bamlanivimab and etesevimab, cut the risk of hospitalization and death among COVID-19 patients by 70 percent in a late-stage clinical trial. The FDA had previously issued an EUA for bamlanivimab in November. New protocols have also enabled a shorter infusion time for bamlanivimab alone and with etesevimab, reducing it from an hour to as few as 16 and 21 minutes, respectively. Eli Lilly has so far made 100,000 doses of the combination therapy available and plans to manufacture an additional 150,000 throughout the first quarter of 2021.The anti-inflammatory drug tocilizumab, most often used to treat rheumatoid arthritis, helped reduce the COVID-19 death rate in a major clinical trial based in the United Kingdom. The RECOVERY Trial tested a group of 2,022 patients receiving tocilizumab, 82 percent of whom also received dexamethasone or a similar steroid, against a control arm of 2,094 patients receiving standard care alone. Results from the study, released last week and not yet peer-reviewed, showed that tocilizumab reduced the rate of death by 14 percent, with a larger reduction among patients on ventilators. Tocilizumab also increased the probability of discharge within 28 days from 47 percent to 54 percent.

2020 was a devastating year for global health. A previously unknown virus raced around the world, rapidly emerging as one of its top killers, laying bare the inadequacies of health systems, and setting back decades of hard-won progress in fighting infectious diseases and improving maternal and child health.Yet as the first major multilateral convening of 2021, the World Health Organization (WHO) Executive Board (EB) meeting, came to a close last week, there was a sense that with the turn of the calendar also comes a fresh sense of palpable optimism that the stage is set for meaningful reforms to build a smarter, more responsive international system for public health and emergency preparedness. This includes opportunities to strengthen the research and development (R&D) ecosystem both for dealing with the ongoing and future pandemics, as well as enduring global health challenges.Leaders push for global effort to “Build Back Better”Member states spent a vast portion of their time during the EB reviewing WHO and global preparedness systems, including the International Health Regulations (IHR)—which govern countries’ obligations for health preparedness—highlighting areas of reform and proposed changes that would make them fit for purpose. Some member states even raised the idea of a pandemic “treaty” that would strengthen the legal requirements attached to the IHR. Encouragingly, while integrating R&D was not a core theme of that dialogue, the notion of ensuring that R&D is a central pillar of the global health security architecture is becoming more mainstream. The Independent Panel for Pandemic Preparedness and Response, which was established by the World Health Assembly (WHA) to assess and recommend actions to strengthen WHO and other global institutions, even highlighted in its progress report that was presented at the EB that “the effective flow and access of new diagnostics, therapeutics, and vaccines to the populations most in need, based on equitable public health criteria, must be the central plank of international co-operative efforts.”As these proposals gain steam, the importance of the Biden-Harris administration’s move to reverse US withdrawal from WHO and recommitment to the institution cannot be overstated. US participation not only strengthens WHO, through funding, technical expertise, and support for research capacity, but also allows global leaders to finally move past some of the political impediments to progress that hampered the overall reform dialogues. Stakeholders can now develop a road map for change that ensures that global response mechanisms are in place to prevent the next pandemic and address the need for stronger governance of research coordination.US reengagement in multilateralism could boost R&D in other multilateral initiatives and foraIn addition to reengaging with WHO, the Biden-Harris administration also announced that the United States will participate in the COVAX Facility, an international effort to develop and equitably distribute vaccines, and donate any surplus vaccines to the cause. Taken together with its announcements of new deals for Pfizer/BioNTech and AstraZeneca/Oxford vaccines, the global effort received a crucial shot in the arm just as stakeholders across the world expressed criticism for slow rollouts and a lack of access to doses for low-income countries. While equity and access will remain major challenges in the short term, this is a step in the right direction and is renewing hope for COVAX to fulfill its mission.The change in US leadership may also benefit other multilateral fora, including the G20 and G7, where concrete action and global health dialogues were often stalled the past four years as countries struggled to find a compromise with the US government’s erratic approach to multilateral engagement. A central focus this year will be a new push for sustainable and innovative financing for pandemic preparedness, and GHTC hopes that this scope will be expanded to address research capacity-building for other health areas. In particular, international financial institutions (IFIs) could play a larger role in providing more stable sources of investment for expanding regional research, late-stage clinical trial, and manufacturing capabilities. Last year, the World Bank already took steps toward implementing new mechanisms to help countries finance the purchase and distribution of COVID-19 vaccines and other health technologies, and there should be continued dialogue around what the Bank and other IFIs can do to advance capacity-building not just for emerging infectious diseases but other key health R&D priorities in low- and middle-income countries.Recommitting to the fight against other global health challenges, not just COVID-19 The WHO EB meeting also signaled a desire by member states to reassert the importance of other global health priorities, including antimicrobial resistance, the Immunization Agenda 2030, neglected tropical diseases (NTDs), and continued discussions around intellectual property. For much of 2020, these WHA workstreams were delayed and stalled as the global community focused almost exclusively on COVID-19. It was therefore encouraging to see global leaders push ahead once more, knowing the dangers of falling further behind.Much of the discussion at the EB centered around accountability and implementation, creating concrete pathways for driving impact in these key areas. Many member states also framed the discussion in a holistic way, highlighting the need for strengthening health systems. Throughout 2020, advocates including GHTC have highlighted how the pandemic underscores both the need and opportunity to make sweeping changes to how global, regional, and country mechanisms support R&D not just for the current and next pandemic, but also for long-standing challenges like malaria, tuberculosis, HIV/AIDS, and NTDs, and for R&D capacity-strengthening to be seen as a key facet of health systems strengthening efforts.Make no mistake, the battle against COVID-19 will continue to dominate the international agenda in the months ahead. But global leaders are starting to recognize that we must concurrently move to build a better, more resilient global health architecture and ensure that we continue the investment in systems and institutions that accelerate the development of new tools and technologies to tackle the global health challenges of the 21st century.