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.

Influenza seasonality and vaccination timing in tropical and subtropical areas of southern and south-eastern Asia

“…40 As a result, many countries have already established influenza vaccine manufacturing capabilities and some used locally produced vaccines during the 2009 pandemic. 41,42 Furthermore, a recent pilot programme of influenza vaccination in the Lao People's Democratic Republic demonstrated that public-private partnerships can improve vaccination programmes in developing countries. 43 The data reported here have limitations.…”

Current prospects and future challenges for nasal vaccine delivery

“…122 No serious side effects have been reported associated with the administration of Nasovac indicating its safety, 123 although its efficacy data are not sufficiently available yet. 124 Until recently FluMist was considered one of the most successful intranasal vaccines, it is well tolerated and had exhibited good efficacy. 125 A runny nose/nasal congestion has been reported as the most common adverse events of Flumist, with mild to moderate in severity.…”

Effectiveness of an Indian-made Attenuated influenza A(H1N1)pdm 2009 vaccine

“…9 After immunogenicity and safety was demonstrated in clinical studies (Prasad S Kulkarni, unpublished data), 10 the vaccine was licensed by the Drug Controller General of India (DCGI) on 3 July 2010. One intra-nasal dose of 0.5 ml was recommended for adults and children ≥3 y of age.…”