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. 2021 Apr 28;39(18):2479-2488.
doi: 10.1016/j.vaccine.2021.03.025. Epub 2021 Apr 7.

Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report

Sonia Pagliusi  1 , Benoit Hayman  2 , Stephen Jarrett  3
Affiliations

Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report

Sonia Pagliusi et al. Vaccine. .

Abstract

The Developing Countries Vaccine Manufacturers' Network held its 21st Annual General Meeting virtually in November 2020 given the COVID-19 pandemic. Vaccine manufacturing experts, leaders from local and global public health organizations and multilateral organizations, through diverse presentations, questions and answers, focused on the pandemic and the response of vaccine manufacturers where many are engaged in research and development and production agreements. The pandemic is expanding rapidly which makes the global availability and equitable access to safe and effective COVID-19 vaccines critical. Strategies put in place include the establishment of the Access to COVID-19 Tools Accelerator (ACT-A) within which the COVAX facility aims to distribute 2 billion COVID-19 vaccine doses by the end of 2021, with procurement mechanisms already being established. At the same time, regulatory authorities have emergency use authorizations aimed at the rapid approval of safe and effective vaccines, with a push for harmonization in regulatory approaches being advocated. The Meeting was also apprised of other innovations being developed for vaccines including multi-array patches for easier vaccine application, increased heat stability for mitigating cold chain and storage challenges, the barcoding of primary packaging for enhancing vaccine traceability, and gathering data for decision-making. Over time, these innovations will facilitate the widespread availability and equitable access of vaccines including those addressing epidemics and pandemics. In addition, a number of manufacturers described technologies they have for accelerating vaccine manufacturing and supply globally. Overall, there was agreement that manufacturers from developing countries play a critical role in the global research, development and supply of vaccines for a healthy future, with increasing collaboration and partnering between them a growing strength.

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Figures

Fig. 1
Fig. 1
ACT-A goal: to rapidly reduce risk of severe disease to end the acute phase of pandemic. Courtesy of B. Aylward, WHO. Legend: ACT-A’s uses parallel workstreams to accelerate the rapid achievement of its goals. A) Context and magnitude of disease burden globally. Only 10 months into the pandemic, nearly 50 million people known to have been infected and 1.2 million people have died to COVID-19. Recent second wave in many European countries have exacerbated the magnitude of the pandemic. B) Covid-19 infection, depending on transmission, has outcomes as asymptomatic and mild disease (80–90% of detected infections), or severe disease (10–20% of detected infections) with hospitalization, that led to health, social and economic disruption in most countries. Major agencies (WHO, GAVI, CEPI, UNITAID, Wellcome Trust, World Bank, The Global Fund, FIND) are collaborating to coordinate the global response, together with other stakeholders, including DCVMN. Commitments of the initiative by end 2021 include 500 million diagnostic tests, 254 million courses of therapy and 2 billion doses of Covid-19 vaccines delivered to developing countries, although access to these tools is hampered by resources and infrastructure. Research, manufacturing, procurement and delivery are being prepared in parallel, to save time to access, and ensure efficient allocation of resources.
Fig. 2
Fig. 2
COVAX Facility focused on transparency, global access and impact. Legend: Participating countries/economies will receive support from UNICEF and the PAHO Revolving Fund for procurement, financing and cold chain infrastructure for delivery, though ultra-cold-chain infrastructure is still under discussion. The facility provides two models of legally binding agreements: a committed upfront payment agreement and an optional agreement, where higher upfront payments with opt out options for vaccines. The manufacturers include the CEPI funded 9 vaccines portfolio (CEPI portfolio: see Fig. 3 (cf. https://cepi.net/research_dev/our-portfolio/). The list of COVAX participating economies and AMC eligible economies, as of December 2020, is available at https://www.gavi.org/sites/default/files/covid/pr/COVAX_CA_COIP_List_COVAX_PR_15-12.pdf.
Fig. 3
Fig. 3
COVID-19 vaccine development landscape: five main technologies and 44 candidates in human clinical trials. Courtesy of M. Saville. Legend: The COVAX R&D&M portfolio consists of 9 candidate vaccines in clinical development. As presented on 05th November, from 44 known COVID-19 candidate vaccines in clinical trials, the COVAX R&D portfolio consists of 9 candidate vaccines in clinical development supported by CEPI (boxes with black frame), whereby 3 have reached phase 3 trials. These candidates, based on multiple technology platforms and diversified across geographies contribute to minimize the risks of hampering global distribution by export and controls of countries hosting manufacturing. Cf. https://cepi.net/research_dev/our-portfolio/
Fig. 4
Fig. 4
Number of UNICEF weekly vaccine shipments in 2020. Courtesy of E. Kadili. Legend: A disruption in airfreight capacity triggered a steep decrease in the volume of vaccine shipments in early April, recovering after May to reach average volumes in October 2020, as compared with shipment numbers in previous years (2017–2019).
Fig. 5
Fig. 5
Expertise and capabilities play a pivotal role in enabling COVID-19 access. Courtesy of A. Zaidi. Legend: Mathematical modelling suggests that an equitable distribution of the first 2 billion doses of an 80% effective COVID-19 vaccine could avert nearly twice as many deaths, as opposed to an exclusive distribution to wealthy countries The global distribution of available excess fill/finish capacity highlights the potential for DCVM partnerships to ensure global supply and access beyond the US and Europe. Note: Where companies do not provide data 10% availability assumed; Source: Drug Product CEPI BMGF PATH CHAI Database (as of 21 May 2020). Cf. https://ww2.gatesfoundation.org/ideas/articles/coronavirus-vaccine-strategy-bill-gates.
Fig. 6
Fig. 6
Overview of WHO’s end-to-end process for aligning the regulation and authorization of vaccines under EUL/PQ. Courtesy of C. Rodriguez. Legend: WHO has a road map for aligning the regulatory processes that impact access to COVID-19 vaccines, which has been ongoing since February 2020. Submissions of vaccines must address product efficacy, safety, quality and programme suitability in order to secure either WHO pre-qualification or an emergency use listing. Countries are able to make regulatory decisions based on WHO prequalification or emergency use listing or on assessments by independent or regional bodies.
Fig. 7
Fig. 7
Rationale for Regulatory Convergence and Harmonization in African countries. Courtesy of S. Azatyan. Legend: About 30% of national regulatory authorities have limited capacity to perform core regulatory functions. Regulatory convergence and harmonization can help such authorities access increased capacity and secure savings enabling health care resources to be better managed. Harmonization through a regulatory network can more easily share best practices with improved outcomes. There are also benefits for manufacturers by reducing their regulatory burden with shorter times to approval at lower cost, as well as being able to improve their access to regional markets such as is the case with the African region.
Fig. 8
Fig. 8
Three innovations have been prioritised by VIPS, which could also facilitate RI catch up/ recovery from COVID-19. Courtesy of B. Giesing and M. Menozzi-Arnaud. Legend: Microarray Patches: Potential to address most immunisation barriers identified by countries and applicable to several vaccines with broad applicability across the life course and outbreak response. Thermostability: Top priority by countries with synergies with other innovations, i.e. MAPs, VVM-Tis, dual chamber delivery devices, SDIs. (SDI = solid dose implant; VVM-Ti: Combined Vaccine Vial Monitor and Threshold Indicator). Barcodes on primary packaging: Greater accuracy in tracking at lower levels of distribution and accelerating the transition to electronic record keeping.
Fig. 9
Fig. 9
The Serialization and Aggregation of traceability. Courtesy of T. Wilmansyah Legend: Vaccine serialization enables traceability which authenticates the products and supports any recalls that may occur. Serialization leads to each vaccine vial or primary packaging to have a unique serial along with other key data such as the GTIN, lot number and expiry date. This enables tracking an individual vial from manufacturer through to final use. Secondary and tertiary packaging have corresponding serialized barcoding that match the barcodes on the primary packaging. Such barcoding is critical for mitigating the risk of counterfeiting. The safety and security of COVID-19 vaccines puts greater focus on the need for traceability through barcoding technology.
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References

    1. https://www.who.int/director-general/speeches/detail/who-director-genera....
    1. Pagliusi S, et al. Emerging manufacturers’ engagements in the COVID −19 vaccine research, development and supply. Vaccine 2020 Jul; 2238(34):5418–5423. https://doi.org/10.1016/j.vaccine.2020.06.022. - PMC - PubMed
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