title: A pandemic influenza vaccine in India: from strain to sale within 12 months.
abstract: In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.
authors.affiliation: Serum Institute of India Limited, 212/2 Off Soli Poonawalla Road, Hadapsar, Pune 411028, Maharashtra, India. rajeev.dhere@seruminstitute.com
authors.forename: Rajeev
authors.initials: R
authors.lastname: Dhere
authors.forename: Leena
authors.initials: L
authors.lastname: Yeolekar
authors.forename: Prasad
authors.initials: P
authors.lastname: Kulkarni
authors.forename: Ravi
authors.initials: R
authors.lastname: Menon
authors.forename: Vivek
authors.initials: V
authors.lastname: Vaidya
authors.forename: Milan
authors.initials: M
authors.lastname: Ganguly
authors.forename: Parikshit
authors.initials: P
authors.lastname: Tyagi
authors.forename: Prajakt
authors.initials: P
authors.lastname: Barde
authors.forename: Suresh
authors.initials: S
authors.lastname: Jadhav
mesh_terms: D006801:Humans; D007194:India / Q000453:epidemiology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; 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*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated