Breakthroughs Blog: COVID-19

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 Saturday authorized Johnson & Johnson’s (J&J) COVID-19 vaccine for emergency use in adults over the age of 18, making it the third vaccine to be approved for use in the United States. The authorization follows a recommendation from an independent advisory panel to the FDA, which convened Friday to review the data and subsequently voted to endorse the vaccine. Phase 3 trial data released in late January showed 66 percent efficacy overall in preventing moderate to severe disease 28 days after vaccination, 72 percent efficacy among participants in the United States, and complete protection against hospitalization and death due to COVID-19, which was reinforced by FDA analysis released in advance of the independent panel meeting last week. The shot—made by J&J’s vaccine division, Janssen—requires only one dose and can be shipped and stored using standard refrigeration. The United States has purchased 100 million doses of the vaccine, and distribution is expected to begin this week.On Wednesday, 600,000 doses of the AstraZeneca/University of Oxford COVID-19 vaccine produced by the Serum Institute of India landed in Accra, Ghana, marking the COVAX Facility’s first delivery to the African continent. Ghana will begin its rollout of the doses early this week, prioritizing frontline health workers and others at high risk. The shipment, a first step toward COVAX’s goal of ensuring equitable access to COVID-19 vaccines around the world, was followed by a delivery to Cote d’Ivoire on Friday, and more shipments are expected in the coming days and months. COVAX intends to deliver nearly 2 billion vaccine doses this year, anticipated to cover up to 20 percent of participating countries’ populations.Last week, Moderna reported it had developed a new version of its COVID-19 vaccine designed to specifically work against the B.1.351 COVID-19 variant, first identified in South Africa. The new vaccine has been sent to the National Institutes of Health, which will test to determine if using it as a booster shot would stimulate a strong immune response. Also last week, Pfizer and BioNTech announced they had initiated a study on the safety and immunogenicity of a third dose of their vaccine to evaluate the effect of a booster on immunity against currently circulating variants, as well as any potential new variants. Both the Moderna and Pfizer/BioNTech vaccines are mRNA based, allowing them to be updated relatively quickly by creating a modified mRNA sequence.

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 Friday, Pfizer and BioNTech announced they are seeking approval from the US Food and Drug Administration (FDA) to store their COVID-19 vaccine for two weeks at temperatures commonly found in pharmaceutical freezers and refrigerators, a change from its currently required ultra-cold storage. The request comes after new data from stability studies showed the vaccine remains stable between -25°C and -15°C (–13°F to 5°F), which has potential to alleviate some logistical hurdles in the vaccine’s distribution. The existing FDA authorization requires storage between -80°C and -60°C (-112°F to ‑76°F). Moderna’s vaccine, by comparison, is shipped at -25°C to -15°C (-13°F to 5°F), while the Johnson & Johnson vaccine is expected to be shipped at 2°C to 8°C (36°F to 46°F) if authorized.Pfizer and BioNTech have begun dosing patients in a clinical trial to evaluate their COVID-19 vaccine among pregnant women, according to a statement released Thursday. The phase 2/3 trial will test the two-dose, mRNA-based vaccine in 4,000 women ages 18 and older who are between 24 and 34 weeks pregnant. Pregnant women were not included in initial vaccine studies, leading to a lack of data and mixed messaging on vaccination recommendations for pregnant individuals. The new Pfizer/BioNTech study will focus on the third trimester of pregnancy to minimize risks to the children and will be conducted in the United States, Europe, South America, and Africa.The World Health Organization (WHO) last week approved AstraZeneca and the University of Oxford’s COVID-19 vaccine as produced by the Serum Institute of India and SKBio for emergency use, making it the second vaccine to receive such a listing after the Pfizer/BioNTech shot was given authorization in late December. The emergency use listing clears the way for the vaccine to be used by the COVAX Facility, a WHO-led global mechanism to procure and equitably distribute COVID-19 vaccines. Pending supply and operational challenges, the goal is for more than 300 million doses of the vaccine to be made available to 145 countries through COVAX in the first half of 2021, according to a statement from AstraZeneca. The authorization follows a recommendation from an independent WHO panel made the week prior.

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.