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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. Two new COVID-19 vaccine candidates, from Novavax and Johnson & Johnson (J&J), will undergo regulatory review for emergency authorization in the coming weeks. On Thursday, Novavax announced rolling reviews of its two-dose vaccine had begun by several regulatory agencies, including the European Medicines Agency, US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency, and Health Canada. Phase 3 trials of the vaccine—preliminary data from which showed 90 percent efficacy in the United Kingdom and 49 percent efficacy in South Africa—will continue while the reviews occur. The same day, J&J announced it had submitted an application for emergency use authorization from the FDA for its single-dose vaccine, after phase 3 trial data indicated the shot was 72 percent effective in the US trial and completely protective against hospitalization and death. An independent advisory committee will meet in late February to review the J&J vaccine data, after which the FDA will make a decision on authorization.Leaders of the COVAX Facility, a global initiative aimed at providing equitable access to COVID-19 vaccines, released plans on Wednesday outlining a country-by-country forecast for vaccine distribution in the coming months. The immediate doses COVAX has secured—336 million from AstraZeneca/Oxford and 1.2 million from Pfizer/BioNTech—are expected to cover about 3.3 percent of the total population of the 145 participating countries within the first half of 2021. Doses will be distributed in proportion to each country’s population size and are anticipated to reach the most vulnerable populations, including health care workers. The details of the plan reflect an estimate of availability and are subject to change based on several factors, including the timeline of regulatory authorization for the AstraZeneca/Oxford vaccine.IAVI and Scripps Research have announced results from a phase 1 clinical trial evaluating a novel vaccine approach to prevent HIV, which showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the virus. The targeted response was detected in 97 percent of participants who received the vaccine. The study, results of which were presented at the virtual International AIDS Society HIV Research for Prevention conference on Wednesday, demonstrated proof of concept for the vaccine approach and will set the stage for continued clinical trials refining and extending the method. IAVI and Scripps intend to move forward by partnering with Moderna to develop and test an mRNA-based vaccine that harnesses the approach to produce the same beneficial immune cells.

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. 

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. Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine candidate showed 66 percent efficacy in preventing moderate to severe disease 28 days after vaccination, according to results from a phase 3 global study released Friday. The trial data differed across geographies, with the vaccine demonstrating 72 percent efficacy among participants in the United States, 66 percent efficacy in Latin America, and 57 percent efficacy in South Africa—adding to concerns about diminished vaccine efficacy against the COVID-19 variant circulating in South Africa and recently detected in the United States. The J&J vaccine also showed complete protection in preventing hospitalization and death due to COVID-19, as well as 85 percent efficacy in preventing severe forms of the disease. J&J plans to apply for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) in early February.On Thursday, Novavax announced 90 percent efficacy of its two-dose COVID-19 vaccine candidate in preliminary results from a phase 3 clinical trial in the United Kingdom, while results from a separate trial indicated 49 percent efficacy of the vaccine in South Africa. The company has said it is already working on a new version of the vaccine designed to combat more infectious strains of the virus, which could also be used as a booster for already-inoculated individuals. The vaccine is also undergoing testing in the United States and Mexico, supported by Operation Warp Speed, which is expected to complete phase 3 enrollment in the first half of February. Novavax expects to file for emergency authorization in the United Kingdom in the coming months once it has final data from the UK trial.In preliminary data released Tuesday, Regeneron reported that its antibody cocktail REGEN-COV was 100 percent effective at preventing symptomatic COVID-19 in participants of an ongoing phase 3 trial among people at high risk of contracting COVID-19 due to exposure to family members with the disease. The data also showed a 50 percent reduction in the overall rate of infection. REGEN-COV was granted an EUA from the FDA in November as a treatment method for patients with mild COVID-19 at high risk of progressing to severe infection, and pending a full readout expected next quarter from the phase 3 prevention trial, the company intends to file to expand the EUA for use as a “passive vaccination” method.

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) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.