advancing innovation for vaccine manufacturers from developing countries prioritization CORD-Papers-2022-06-02 (Version 1)

Title: Advancing innovation for vaccine manufacturers from developing countries: Prioritization barriers opportunities
Abstract: Development of novel vaccines and improving existing vaccines is critical to addressing areas of unmet or under-addressed health needs globally and to improving existing vaccination coverage and equity. However vaccine innovation is costly and highly complex. To understand how vaccine manufacturers from developing countries approach innovation a survey was conducted among company members of the Developing Countries Vaccine Manufacturers Network in collaboration with the Clinton Health Access Initiative. The survey confirmed that vaccine manufacturers from developing countries are committed to vaccine innovation: 95% of respondents have interest in pursuing vaccine innovation with strategies targeted towards supplying to low- and middle-income countries. Key barriers to innovation were also surveyed with respondents highlighting challenges regarding access to in-licensing or joint venture partnerships financing and regulatory barriers. Opportunities for innovation are also discussed.
Published: 2021-02-22
Journal: Vaccine
DOI: 10.1016/j.vaccine.2020.12.085
DOI_URL: http://doi.org/10.1016/j.vaccine.2020.12.085
Author Name: Hayman Benoit
Author link: https://covid19-data.nist.gov/pid/rest/local/author/hayman_benoit
Author Name: Bowles Alex
Author link: https://covid19-data.nist.gov/pid/rest/local/author/bowles_alex
Author Name: Evans Beth
Author link: https://covid19-data.nist.gov/pid/rest/local/author/evans_beth
Author Name: Eyermann Elizabeth
Author link: https://covid19-data.nist.gov/pid/rest/local/author/eyermann_elizabeth
Author Name: Nepomnyashchiy Lyudmila
Author link: https://covid19-data.nist.gov/pid/rest/local/author/nepomnyashchiy_lyudmila
Author Name: Pagliusi Sonia
Author link: https://covid19-data.nist.gov/pid/rest/local/author/pagliusi_sonia
license: cc-by
license_url: https://creativecommons.org/licenses/by/4.0/
source_x: Medline; PMC
source_x_url: https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 33487466
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/33487466
pmcid: PMC7909323
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7909323
url: https://www.ncbi.nlm.nih.gov/pubmed/33487466/ https://doi.org/10.1016/j.vaccine.2020.12.085
has_full_text: TRUE
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Extracted PMC Text Content in Record: First 5000 Characters:The Developing Countries Vaccine Manufacturers Network (DCVMN) is a public-health driven alliance representing vaccine manufacturers from developing countries, as defined by the United Nations' World Economic Situation and Prospect report [1]. Network manufacturers are engaged in research, development, manufacturing and supply of vaccines for local and international use, aiming to protect all people against known and emerging infectious diseases. In 2019, an internal survey reported that 33 manufacturers from this global Network had 181 vaccine projects in the Research and Development (R&D) pipeline, of which 24 were novel vaccines [2]. Over the past decade these manufacturers have demonstrated an increasing commitment to innovation, looking to develop novel vaccines against emerging disease, in addition to improving product presentation of existing vaccines [3]. R&D focus on innovative vaccines is crucial to increasing immunization coverage and reducing mortality and morbidity from infectious diseases. The Clinton Health Access Initiative (CHAI) is a global health, non-profit organization committed to saving lives and reducing the burden of disease in low-and middle-income countries. CHAI works to strengthen the capabilities of governments and the private sector to create and sustain high-quality health systems, with a team focusing on improving access to vaccines in low- and middle-income countries. CHAI and DCVMN have collaborated to better understand the innovation challenges faced by vaccine manufacturers from developing countries (hereafter referred to as DCVMs). As part of this effort, a survey was distributed to members of DCVMN to better understand: 1) the extent to which DCVMs prioritize innovation and for which markets; 2) how these manufacturers engage in innovation; and 3) the key barriers to innovation. In addition to reviewing the output of the survey, this report highlights opportunities for advancing innovation. To understand how vaccine manufacturers from developing countries approach innovation, a 17-question survey (Annex 1) was designed by the CHAI vaccines' team in consultation with the DCVMN Secretariat with the following objectives:•Quantify the extent to which innovation is a manufacturer priority.•Understand how manufacturers engage in the innovation pathway (e.g. stages of product development, partnerships, market focus/priority areas).•Identify the key barriers to innovation for DCVMs This survey focused on two key types of vaccine innovation: novel vaccines and improved vaccines. - Novel vaccines: unique vaccines for diseases with no approved vaccines yet (e.g., Chikungunya, Zika, HIV). - Improved vaccines: vaccines which offer additional value over existing products in terms of antigen attributes, thermostability, and/or presentation (e.g., rotavirus, pneumococcal vaccine). On 19th November 2019, the link to the online survey was circulated by email to all 42 members of the Network, at that time, soliciting both quantitative and qualitative responses. The survey closed on the 19th February 2020. The data was then analysed to produce the findings presented in this report1. Vaccine manufacturing is complex, and significant time and costs are associated with product development. Advancing a vaccine from pre-clinical development to launching has a very large range estimated risk-adjusted cost of between 18.1 million to 1 billion USD [4] depending on multiple factors. Results from the survey indicate that almost 95% of respondents currently have a strategy to pursue development of completely novel vaccines. This commitment is reflected in respondents' R&D investment: the arithmetic mean of the reported percentages of overall investments dedicated to novel and improved vaccines was approximately 35%– with a roughly 50–50 split across the two types of innovation (Table. 1). This is particularly interesting given reports showing a decline in multinational corporations (MNCs) innovation output [5]. DCVMs are motivated by their mission to protect people from known and emerging infectious diseases and to produce innovative vaccines, particularly targeted towards low- and middle-income economies. Survey results show that approximately 89% of respondents have a strategy to pursue innovation targeting low-income markets while over 94% reported having a strategy to target innovation in middle-income markets (Fig. 1). In 2018, vaccine manufacturers from developing countries produced over 50% of the vaccine doses procured by UNICEF globally [6]. Such efforts are critical in assuring vaccines are supplied to where they are needed most, such as in countries where the incidence of infectious disease is often the highest. For example, 62% of the world's unprotected children reside in 10 low- to middle-income countries [7] and nations in sub-Saharan Africa, South Asia and Latin America are at risk from five or more major vector-borne diseases [8]. DCVMN members have a track record of innovations in
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