NIJMEGEN, The Netherlands, January 6 /PRNewswire/ --
MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza.
The MAA submission for LAIV is based on data from 73 global clinical and U.S. post-marketing studies of more than 141,000 subjects ranging in age from 7 weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.