Countering the Pandemic Threat Through Global Coordination on Vaccines The Influenza Imperative (2022) / Chapter Skim
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4 Technology and Manufacturing Partnerships
4 Technology and Manufacturing Partnerships
Pages 79-114
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From page 79... ...
The company's chief scientific officer and president of research and development (R&D) , Michael Dolsten, informed investors that Pfizer will start clinical trials for its influenza mRNA vaccine during the third quarter of 2021 (LaMattina, 2021)
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From page 80... ...
To confer protection against infectious diseases, mRNA vaccines introduce a piece of mRNA that corresponds to a protein or a component thereof in the virus, inducing cells in the body to produce that protein, triggering an immune response that produces antibodies against the protein that persist and can prevent infection and serious illness after exposure to the target virus. COVID-19 vaccines based on the adenovirus vector technology trigger an immune response using a nonreplicating viral vector that delivers the genetic code for the spike protein on the surface of the SARS-CoV-2 virus.
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United States COV2.S) Peptide vaccine EpiVacCorona Federal Budgetary Research Russia Institution State Research Center of Virology and Biotechnology, Rospotrebnadzor Recombinant Sputnik V Gamaleya Research Institute, Russia adenovirus Acellena Contract Drug Research vaccine (rAd26 and Development and rAd5)
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From page 82... ...
This represents a potentially transformative inflection point in the influenza vaccine manufacturing landscape. Certain technologies supported by BARDA for pandemic influenza -- mRNA (Moderna)
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Although it would require substantial R&D followed by clinical trials, this underscores the potential to transfer platform technologies for pandemic influenza vaccines and therapeutics to other emerging infectious diseases and vice versa (Newland et al., 2021)
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. According to the analysis of global production capacity of seasonal and pandemic influenza vaccines in 2019 (Sparrow et al., 2021)
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Recombinant vaccines can be produced on a much more rapid time line than either, largely because they are not dependent on a CVV, but they represent only a small fraction of the current global vaccine production capacity. The technologies that dominate the influenza vaccine manufacturing system are, therefore, not optimal.
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From page 86... ...
. Figure 4-2 provides a visual depiction of the global vaccine landscape at the preclinical and early clinical trial phases, with six different types of platforms: recombinant proteins, non-virus-like particles (nanoparticles)
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. ACCELERATING THE DEVELOPMENT OF PLATFORM TECHNOLOGIES FOR INFLUENZA Accelerating the development of platform technologies for influenza vaccines over the next 3–5 years will enhance the speed of production and potential efficacy.
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In the same year, the Wellcome Trust announced its support for the Center for Infectious Disease Research and Policy (CIDRAP) to develop a roadmap for R&D for influenza vaccines to accelerate progress toward universal or broadly protective influenza vaccines; it was published in September 2021.5 A 2020 report by the Sabin-Aspen Vaccine Science and Policy Group surveyed the current state of progress toward a universal influenza vaccine, 5 See https://www.cidrap.umn.edu/ongoing-programs/influenza-vaccines-roadmap (accessed December 19, 2021)
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From page 89... ...
First, CEPI works to counter known threats through "proof-of-concept safety testing" and will establish vaccine stockpiles as a preparedness measure. Second, CEPI funds new and innovative platform technologies with a potential to "accelerate the development and manufacturing of vaccines against unknown pathogens," with an intent to meet a time line of 16 weeks from antigen identification to product release for clinical trials.
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From page 90... ...
Other entities might be able to play a role in coordinating and leading a push for a universal influenza vaccine. The Global Funders Consortium for Universal Influenza Vaccine Development, established in 2017 to convene organizations and governments that fund R&D for universal influenza vaccines in particular, has been and can continue to be involved in identifying funding gaps and promoting dialogue between key stakeholders.
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From page 91... ...
. In June 2021, The Rockefeller Foundation urged G7 leaders to adopt its Updated Action Plan for Global COVID-19 Vaccination, which calls for regional manufacturing hubs in the Global South to narrow the gap between vaccine manufacturing capacity between the developed and developing worlds (The Rockefeller Foundation, 2021)
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From page 92... ...
Between April and June 2021, the Partnership for Africa Vaccine Manufacturing was also launched by the Africa CDC and the African Union. The goal of the partnership is that by 2040, African countries should produce at least 60 percent of the vaccines they use, as opposed to the current 1 percent (Africa CDC and African Union, 2021)
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To support the transition and increase influenza vaccine production capacity, six capabilities are required, all of which rely on strong global partnerships: 1. Robust early-phase R&D -- particularly Phase III clinical trials -- focused on platform technologies for influenza and, ideally, a plat form-based universal influenza vaccine; 2.
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. Gaps in R&D governance include no coordinated commitment to funding R&D for universal influenza vaccines, which warrants new public–private partnerships similar to those established for COVID-19 vaccine development (Krammer et al., 2018)
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From page 95... ...
supports scientists and research funders in identifying optimal research solutions and channeling the necessary funds into those solutions rapidly, which also conserves resources and avoids duplication. Glopid-R has facilitated collaboration between India and the European Union focused on next-generation influenza vaccines (Chaudhury, 2020)
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From page 96... ...
Although OWS was successful in accelerating the development of safe and effective vaccines, it was less successful in expanding manufacturing capacity and facilitating the administration of those vaccines, with around 2–3-fold fewer vaccine doses administered than planned. A major boon to OWS was the use of clear criteria for company selection based on robust preclinical and early-stage clinical trial data that suggested the potential to enter Phase III field efficacy trials between July and November 2020, with outcomes by the first half of 2021.
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From page 97... ...
was designed to bolster the market for influenza vaccines and sustainably increase manufacturing capacity. GAP aimed to increase the supply of a pandemic vaccine and thereby reduce the gap between the potential vaccine demand and supply anticipated during an influenza pandemic (WHO, n.d.)
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The Global Action Plan for Influenza Vaccines (GAP) was born from a consultation organized by the World Health Organization (WHO)
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, seasonal influenza vac cine production capability increased from 500 million to 1.47 billion doses and pandemic vaccine production capacity increased from approximately 1.5 to 6.37 billion doses (McLean et al., 2016)
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. However, to address these challenges, a wealth of resources and expertise can be provided by regional and global industrial organizations, such as the African Vaccine Manufacturing Initiative, Developing Country Vaccine Manufacturing Network (DCVMN)
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. Manufacturing Capacity: Barriers In the push for distributed manufacturing, it is important not to underestimate the difficulties intrinsic to actually accomplishing one-time
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GAP (2006–2019) and BARDA's International Influenza Vaccine Manufacturing Capacity Building Program employed a partnership model based on distributed, egg-based vaccine manufacturing capacity (see Box 4-1)
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Despite the program's successes, it was merely a drop in the bucket in terms of expanding global vaccine manufacturing capacity. It was estimated that successful grantees with a licensed vaccine and functional facility could collectively produce a maximum of 675.2 million doses of pandemic vaccine in 12 months, which represented only 8.13 percent of the total global capacity in 2019.
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From page 104... ...
According to an analysis of scale of production and its influence on costs for influenza vaccines at WHO, manufacturing costs were much greater at a small than a large scale. Although local production might seem like the best option for achieving a sustainable supply, governments may not have considered how this strategy may increase costs.
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From page 105... ...
BARDA also partnered with PATH to provide targeted technical support to manufacturers of influenza vaccines nearing eligibility for licensure. The GAP experience illustrates that training over a few years is critical: manufacturers were encouraged to send 2–3 staff members to these facilities each year, which was reinforced with onsite training.
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From page 106... ...
. The Africa CDC Consortium for COVID-19 Vaccine Clinical Trials, launched July 2020 by the African Union Commission, may provide an instructive example of how to regionally support testing, regulatory approval, and access to COVID-19 vaccines in alignment with geographically distributed hubs (Africa CDC, 2020)
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From page 107... ...
The UK Vaccine Task Force, launched in May 2020, included experts from the military and pharmaceutical industry and civil servants with expertise in preclinical and clinical development, regulatory issues, manufacturing, and project management. Close support by the UK government in building supply chains for pharmaceutical firms, and "effectively commandeering" a manufacturing facility while securing exclusive access to another, have been cited as major factors in the success of this effort (Hoen et al., 2021)
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From page 108... ...
• Several existing organizations may be able to lead large-scale R&D and clinical trials for influenza platform technologies, including large-scale global action in LMICs, if they are given expanded mandates that are matched with significant infusions of funding. These could include CEPI, BARDA, and the HERA Incubator.
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From page 109... ...
Supporting Geographically Distributed Regional Manufacturing Hubs • Geographically distributed manufacturing hubs are a way to pro vide scaled-up vaccine manufacturing in LMICs. The difficulty is in how to scale up industry partnerships and apply them globally, in support of a geographically distributed manufacturing hub model.
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From page 110... ...
• A business model for pandemic influenza vaccines requires a dual use paradigm for manufacturing facilities to keep them functioning between pandemics. This should encourage investment in platform technologies for vaccines for both seasonal influenza and other pathogens.
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2020. India, EU working to develop new generation of influenza vaccines: Envoy.
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2021. Scaling up vaccine production capacity: Legal challenges and recommendations.
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2021. Building the global vaccine manufacturing capacity needed to respond to pandemics. Vaccine 39(12)
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2021. Global production capacity of seasonal and pandemic influenza vaccines in 2019.
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