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      Strengthening vaccines and medicines manufacturing capabilities in Africa: challenges and perspectives

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          Abstract

          Africa carries a high burden of infectious diseases. Every year, millions of Africans contract tuberculosis, malaria, and many other diseases. Malaria kills hundreds of thousands of children under the age of five years annually. More than 11,000 people died during the 2014–2016 Ebola outbreak in West Africa; still, occasional cases of Ebola, as well as monkeypox, periodically appear in the Democratic Republic of Congo. Since most of the African countries gained their independence during the 1960s, the continent has relied heavily on the outside world for diagnostics, medicines, vaccines, personal protective equipment, and other medical supplies. Africa consumes nearly 25% of the globally produced vaccines but imports 99% and 95% of its vaccines and medicines, respectively. The 55 African countries were not able to ensure the health of 1.3 billion Africans during the COVID‐19 pandemic but had to rely on other global initiatives and other countries for help and support. However, the pandemic and the shortage of vaccines may have been the much‐needed trigger for this situation to change. “When misfortunes increase, they erase each other.” Naguib Mahfouz (1911–2006).

          Abstract

          In this Commentary, A. Saied & colleagues discuss the current situation in Africa regarding vaccine manufacturing and distribution, as well as challenges and perspectives to achieve a greater independence.

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          Most cited references9

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          Rapid Establishment of a Cold Chain Capacity of –60°C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone

          In response to the 2014‒2015 Ebola virus disease (Ebola) epidemic in West Africa, researchers accelerated the development of Ebola vaccines. The Centers for Disease Control and Prevention, in collaboration with local partners, sponsored a phase 2/3 trial in Sierra Leone of a single dose (2 × 10 7 plaque-forming units/mL) of a candidate replication-competent recombinant vesicular stomatitis virus–Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Because of its early development status and limited, critical stability data, the vaccine had to be stored at –60°C or colder. Planning for the trial began in late 2014 on an accelerated timeline with significant challenges, including the lack of –60°C or colder vaccine storage, handling, and transport capability in a country with high year-round ambient temperatures. The supply chain needs for vaccine handling from storage through transport, up to the time of administration, were carefully evaluated, and then the supply chain was designed. Critical equipment that was procured, shipped, installed, and qualified to meet an aggressive timeline for launching the trial included ultracold freezers, custom-developed Arktek DF containers for storage at –60°C or colder, insulated containers for storage at 2°C–8°C, and multiple backup power sources at vaccine storage sites. Local personnel were trained in good clinical practices and trial documentation. During 9 April–12 December 2015, the trial staff vaccinated approximately 8000 participants. Five temperature excursions occurred, but the vaccine manufacturer assessed that vaccine quality was not impaired because of improper storage or transport temperatures. Both the infrastructure and the human capacity developed for the cold chain during the trial will continue to be useful as the country maintains preparedness for ring vaccination responses and future clinical research. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].
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            Management of COVID-19 vaccines cold chain logistics: a scoping review

            Background Successful mass vaccination programmes are public health achievements of the contemporary world. While pharmaceutical companies are actively developing new vaccines, and demonstrating results of effectiveness and safety profiles, concerns on COVID-19 vaccine management are under-reported. We aimed to synthesise the evidence for efficient cold chain management of COVID vaccines. Methods The scoping review’s conduct and reporting were based on the PRISMA–ScR 2018 checklist. We searched from April 2020 to January 2022 for publications in PubMed (LitCovid), Scopus and ScienceDirect. All review stages were pilot-tested to calibrate 2 reviewers. Articles on cold chain logistics and management were included, while publications solely describing COVID vaccines, their development and clinical aspects of the vaccine, were excluded. To capture relevant data, charting was conducted by one reviewer and verified by another. Results were analysed thematically and summarised descriptively in a table and in-text. Results and discussion We assessed 6984 potentially relevant citations. We included 14 publications originating from USA ( n  = 6), India ( n  = 2), Finland, Spain, Bangladesh, Netherlands, Switzerland and Ethiopia. They were reported as reviews (4), policy or guidance documents (3), experimental studies (2), case reports (2), expert commentary (1), phenomenological study (1), and decision-making trial and evaluation laboratory trial (1). The findings were presented in three themes: (i) regulatory requirements for cold-chain logistics, (ii) packaging and storage, and (iii) transportation and distribution. A conceptual framework emerged linking regulatory requirements, optimal logistics operation and formulation stability as the key to efficient cold chain management. Recommendations were made for improving formulation stability, end-product storage conditions, and incorporating monitoring technologies. Conclusion COVID-19 vaccines require special end-to-end supply cold chain requirements, from manufacture, and transportation to warehouses and healthcare facilities. To sustain production, minimise wastage, and for vaccines to reach target populations, an efficient and resilient vaccine supply chain which is assisted by temperature monitoring technologies is imperative. Supplementary Information The online version contains supplementary material available at 10.1186/s40545-022-00411-5.
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              Covid-19: WHO efforts to bring vaccine manufacturing to Africa are undermined by the drug industry, documents show

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                Author and article information

                Contributors
                saied_abdelrahman@yahoo.com
                Journal
                EMBO Mol Med
                EMBO Mol Med
                10.1002/(ISSN)1757-4684
                EMMM
                embomm
                EMBO Molecular Medicine
                John Wiley and Sons Inc. (Hoboken )
                1757-4676
                1757-4684
                27 June 2022
                August 2022
                : 14
                : 8 ( doiID: 10.1002/emmm.v14.8 )
                : e16287
                Affiliations
                [ 1 ] National Food Safety Authority (NFSA) Aswan Egypt
                [ 2 ] Ministry of Tourism and Antiquities Aswan Egypt
                [ 3 ] Department of Surgery, Anesthesiology, and Radiology, Faculty of Veterinary Medicine Aswan University Aswan Egypt
                [ 4 ] Department of Microbiology Punjab Agricultural University Ludhiana Punjab India
                [ 5 ] Trafford College, Altrincham Manchester UK
                [ 6 ] Department of Veterinary Anatomy and Histology, College of Veterinary Sciences and Animal Husbandry Central Agricultural University (I), Selesih Aizawl Mizoram India
                [ 7 ] Department of Family Medicine Suez Canal University Ismailia Egypt
                [ 8 ] Department of Cardiovascular Perfusion SUNY Upstate Medical University Syracuse NY USA
                [ 9 ] Department of Medicine SUNY Upstate Medical University Syracuse NY USA
                [ 10 ] Department of Surgery SUNY Upstate Medical University Syracuse NY USA
                Author notes
                [*] [* ]Corresponding author. E‐mail: saied_abdelrahman@ 123456yahoo.com
                Author information
                https://orcid.org/0000-0001-8616-5874
                https://orcid.org/0000-0001-8565-8220
                https://orcid.org/0000-0002-7783-7138
                https://orcid.org/0000-0001-6929-675X
                https://orcid.org/0000-0001-9191-7479
                Article
                EMMM202216287
                10.15252/emmm.202216287
                9358391
                35758210
                06f8a496-a889-4174-a6d8-d8421e3f8383
                © 2022 The Authors. Published under the terms of the CC BY 4.0 license.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 09 June 2022
                : 10 May 2022
                : 10 June 2022
                Page count
                Figures: 2, Tables: 3, Pages: 6, Words: 3740
                Categories
                Commentary
                Commentary
                Custom metadata
                2.0
                08 August 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:08.08.2022

                Molecular medicine
                africa,covid‐19,manufacturing,mrna vaccine,vaccines,economics, law & politics,microbiology, virology & host pathogen interaction

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