title: Development of pandemic influenza vaccine production capacity in Viet Nam.
abstract: The Institute of Vaccines and Medical Biologicals (IVAC), a state-owned vaccine manufacturer, initiated research into avian influenza vaccines in the early 1990 s in response to the threat of a highly pathogenic avian influenza pandemic. Successful results from laboratory studies on A(H5N1) influenza virus attracted seed funds and led to participation in the WHO technology transfer project to enhance influenza vaccine production in developing countries. IVAC's goal is to produce 500,000 doses of inactivated monovalent whole-virion influenza vaccine per year by 2012, and progressively increase capacity to more than 1 million doses to protect essential populations in Viet Nam in the event of an influenza pandemic. The WHO seed grants, supplemented by other international partner support, enabled IVAC to build in a very short time an influenza vaccine manufacturing plant under Good Manufacturing Practice and relevant biosafety standards, a waste treatment system and a dedicated chicken farm for high-quality eggs. Much of the equipment and instrumentation required for vaccine production has been installed and tested for functional operation. Staff have been trained on site and at specialized courses which provided comprehensive manuals on egg-based manufacturing processes and biosafety. Following process validation, clinical trials will start in 2011 and the first domestic influenza vaccine doses are expected in 2012.
authors.affiliation: Institute of Vaccines and Medical Biologicals (IVAC-VIETNAM), 9 Pasteur Street, Nha Trang City, Khanh Hoa Province, Viet Nam. lekimhoa@dng.vnn.vn
authors.forename: L K
authors.initials: LK
authors.lastname: Hoa
authors.forename: L V
authors.initials: LV
authors.lastname: Hiep
authors.forename: L V
authors.initials: LV
authors.lastname: Be
mesh_terms: D002986:Clinical Trials as Topic; D006291:Health Policy; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D058873:Pandemics / Q000517:prevention & control; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000458:organization & administration*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution; D014744:Vietnam / Q000453:epidemiology; D014944:World Health Organization
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated