A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac ® ) in India

• Published in: Human vaccines & immunotherapeutics Vol. 9; no. 1; pp. 122 - 124
• Main Authors: Kulkarni, Prasad S., Raut, Sidram K., Dhere, Rajeev M.
• Format: Journal Article
• Language: English
• Published: United States Landes Bioscience 01.01.2013
• Subjects: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Female; Humans; India; Influenza A Virus, H1N1 Subtype - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Influenza, Human - prevention & control; Influenza, Human - virology; Male; Middle Aged; Product Surveillance, Postmarketing; Retrospective Studies; Short Report; Vaccines, Attenuated - administration & dosage; Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Young Adult; India
• ISSN: 2164-5515; 2164-554X; 2164-554X
• DOI: 10.4161/hv.22317

A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (³ 3 years) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 days. Among 7565 individuals (3 - 85 years), a total of 81 solicited adverse reactions (1%) were reported in 49 subjects (0.65%). The reactions included mild to moderate respiratory symptoms. No H1N1 case was encountered during one year postvaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.