title: Development of influenza vaccine production capacity by the Government Pharmaceutical Organization of Thailand: addressing the threat of an influenza pandemic.
abstract: In 2005, a year after highly pathogenic avian influenza outbreaks in Thailand, the Thai Government issued a National Strategy Plan for Pandemic Influenza Preparedness, a major objective of which was the domestic production of seasonal influenza vaccine. It was considered that sustained influenza vaccine production was the best guarantee of a pandemic vaccine in the event of a future pandemic. The Government decided to provide funds to establish an industrial-scale influenza vaccine production plant, and gave responsibility for this challenging project to the Government Pharmaceutical Organization (GPO). In 2007, with support from the World Health Organization (WHO), the GPO started to develop egg-based, trivalent inactivated influenza vaccine (IIV) in a renovated pilot plant. In early 2009, during the second year of the project, the GPO turned its attention to develop a pandemic live attenuated influenza vaccine (PLAIV) against the influenza A (H1N1) virus. By December 2010, the H1N1 PLAIV had successfully completed Phase II clinical trials and was awaiting registration approval from the Thai Food and Drug Administration (TFDA). The GPO has also started to develop an H5N2 PLAIV, which is expected to enter clinical trials in January 2011. The next step in 2011 will be the development and clinical evaluation of seasonal LAIV. To meet the needs of the national seasonal influenza vaccination programme, the GPO aims to produce 2 million doses of trivalent IIV in 2012 and progressively increase production to the maximum annual capacity of 10 million doses. This article relates how influenza vaccine production capacity was developed and how major challenges are being met in an expeditious manner, with strong local and global commitment.
authors.affiliation: Government Pharmaceutical Organization, 75/1 Rama VI Road, Ratchathewi, Bangkok 10400, Thailand.
authors.forename: Somchaiya
authors.initials: S
authors.lastname: Surichan
authors.forename: Ponthip
authors.initials: P
authors.lastname: Wirachwong
authors.forename: Wutichai
authors.initials: W
authors.lastname: Supachaturas
authors.forename: Kanchala
authors.initials: K
authors.lastname: Utid
authors.forename: Sompone
authors.initials: S
authors.lastname: Theerasurakarn
authors.forename: Pimsuk
authors.initials: P
authors.lastname: Langsanam
authors.forename: Pattharachai
authors.initials: P
authors.lastname: Lakornrach
authors.forename: Ladda
authors.initials: L
authors.lastname: Nitisaporn
authors.forename: Chanpen
authors.initials: C
authors.lastname: Chansikkakorn
authors.forename: Wilak
authors.initials: W
authors.lastname: Vangkanonta
authors.forename: Ruangchai
authors.initials: R
authors.lastname: Kaweepornpoj
authors.forename: Kittisak
authors.initials: K
authors.lastname: Poopipatpol
authors.forename: Sit
authors.initials: S
authors.lastname: Thirapakpoomanunt
authors.forename: Somchai
authors.initials: S
authors.lastname: Srichainak
authors.forename: Witit
authors.initials: W
authors.lastname: Artavatkun
authors.forename: Vichai
authors.initials: V
authors.lastname: Chokevivat
authors.forename: Suwit
authors.initials: S
authors.lastname: Wibulpolprasert
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; 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; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000458:organization & administration*; D013785:Thailand / Q000453:epidemiology; D014944:World Health Organization
chemical_list: D007252:Influenza Vaccines