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AFRICAN VACCINE MANUFACTURING INITIATIVE

EXECUTIVE SUMMARY

The AVI Workshop was held over two days on the 13th and 14th December 2010 in Cape Town, South Africa. Except for the representative from Egypt, who tendered his apologies, it was attended by all members of the AVI task group who were instrumental in launching the African Vaccine Initiative (AVI) during the International Vaccine Technology Workshop (IVTW) held in Hyderabad, India on the 17th and 18th September, 2010.


The agenda for the AVI workshop included the following topics : (1) Background to the meeting in Hyderabad ; (2) Background of delegates - organisational affiliation, country’s disease profile, and challenges regarding vaccine preparedness and self-sufficiency ; (3) AVI’s Purpose, Objectives and Strategy ; (4) AVI Legal and Governance Issues ; (4) AVI Organisational Issues, including a plan for the AVI over the next 6 months, (5) Updates on Stakeholder Relationships, and finally, (6) Funding Sources. 1. Background to the Meeting in Hyderabad Abdulasalami Nasidi (MicroNas Bio-Pharm, Abuja, Nigeria) provided the background events that led to the current workshop. The workshop was convened as a result of the outcome of a side meeting, which took place at the International Vaccines Technology Workshop (IVTW) in Hyderabad, India on the 17th and 18th September 2010, when a group of concerned Africans from South Africa, Nigeria, Senegal, Egypt, the DRC and Congo (task group) got together to launch an initiative called the African Vaccine Initiative (AVI) in response to Africa’s lack of capacity to manufacture flu pandemic and other strategic vaccines required in emergency situations.

This task group adopted a strategy for the AVI which involved the development of a coordinated and organized approach to support efforts in Africa aimed at establishing sustainable vaccine manufacturing capacity in the continent in order that Africa can be self-sufficient in vaccines supply and improve its preparedness to respond to pandemic situations. The AVI would seek financial, technical and advocacy support and assistance from global partners to realize this goal.

The AVI task group agreed at that meeting to convene a workshop in Cape Town, South Africa to develop a framework and structures necessary for the running and governance of the AVI. It was expected that workshop would also develop proposals and strategies on how best key global stakeholders like the US government, WHO, the Bill and Melinda Gates Foundation, Path, GTZ and similar organisations can play a role in assisting the AVI in achieving its objectives.

2. Background of Delegates Organisational Affiliations, Country’s Disease Profile & Challenges Presentations were made by the following delegates : Jean-Jacques Mayembe-Tamfun (JJM) from the INRB (Institut National De Recherche Biomedicale), DRC Antoine Diatta (AD) from the IPD (Institut Pasteur Dakar), Senegal Cheikh Saad-Bouh Boye (CSB) from IDR (Inst Drug Res Dakar), Senegal Jean-Vivien Moumbouli (JV) from the LNSP, Congo Abdulasalami Nasidi (AN) from MicroNas Bio-Pharm, Abuja, Nigeria Patrick Tippoo (PT) from TBI (The Biovac Institute), South Africa

JJM Presentation (DRC) : The mission of the INRB is to serve as a Centre of Excellence (CoC) for medical analysis, biological surveillance of infectious and parasitic diseases, applied biomedical research, and the production and distribution of biological products (vaccines. The Institute is divided into : Clinical Laboratories, an Applied Research unit, a laboratory for Disease Surveillance, a Reference Laboratory and Training Services. The DRC experiences regular outbreaks of vaccine preventable diseases such as the plague, Marburg, Ebola, Cholera, Shigellosis, Monkey Pox (MPX), Polio, MDR-TB and XDR-TB in different parts of the DRC. Although the outbreak of the pandemic H1N1 Flu virus in October 2009 did not severely affect the country, there was no vaccine available for vaccination. In the past the DRC produced liquid Smallpox vaccines in Boma, Kisangani, Bukavu and Kasongo, and freeze-dried Smallpox vaccine in Lubumbashi. Rabies vaccine and Plague vaccine were produced in Lubumbashi and Blukwa respectively. The President of the DRC has been briefed of the AVI and is he is highly supportive of the Initiative. JJM’s expectation for the workshop was that concrete resolutions would be taken on issues such as the transfer of technology, training and scientific facilities.

AD Presentation (Senagal) : The Institut Pasteur Dakar (IPD), in Senegal, was established in 1924 and in 2010 became an Senagalese Foundation. The IPD has been a sustainable entity for the past 86 years. Its infrastructure and activities include : a WHO pre-qualified facility for production of YF vaccine 17D, service laboratories, a Reference Laboratory and Research Units for virology, immunology, bacteriology, entomology and epidemiology. The IPD has developed short-, medium- and long-term perspectives on building and development of production capacity. The short to medium term goal is to increase production capacity up to, or greater than 20 million doses per year of YF vaccine to meet the needs of Africa. The partners in this venture are : the Senegalese Government, Institute Pasteur in France, IPD, WHO, UNICEF and AFD (African Development Bank). In the medium to long term, the IPD plans to install additional capacity for the production of either other live attenuated influenza vaccines or chimeric recombinant live vaccines based on YF or influenza. The IPD expects that the AVI will be able to facilitate the exchange of ideas and experiences between its various members ; provide support to African countries to develop their own vaccine production capacity ; provide assistance to African manufacturers to obtain financial support for production and R&D programmes, promote collaboration and networking between African vaccine manufacturers, and finally, promote excellence in R&D and production Quality Control

CSB Presentation (Senegal) : The Institute for Drug Research (IDR) is involved in R&D on HIV, Malaria, infectious diseases and GMP training. Its goal is to help the IPD in the first instance with the development of vaccines for Hep B, influenza and an improved Yellow Fever vaccine, and in the second instance, to expand vaccine production to supply the whole of the West African region. The IDR is currently rendering assistance to Africaseptic (s.a.r.l), a new private initiative that is building a facility in Senegal applying the Crystal® Closed Vial Technology for vial filling of bulk supplied vaccines and biological products. It is intended that the vaccine will be supplied to local governments and all of West Africa via large organisations like the WHO, UNICEF and GAVI. The private company undertaking the project has international stakeholders and is fully supported by the Minister of Health and the WHO. The company has partnered respectively with Biopharma, India, and GSK to ensure that the bulk filling is properly QC/QA controlled, and R&D is adequately supported.

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Workshop
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Meeting
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