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

A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (>= 3 y) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 d. Among 7,565 individuals (3-85 y), 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 post vaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.