The proposed indication in the marketing authorization application (MAA) is for the prevention of seasonal influenza.
The MAA submission for live attenuated influenza vaccine (LAIV) is based on data from 73 global clinical and US post-marketing studies of more than 141,000 subjects ranging in age from seven weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.
Each dose of LAIV is formulated to contain three live attenuated influenza virus strains, which are weakened as to not cause illness: two type A influenza strains (A/H1N1 and A/H3N2) and one type B strain. The vaccine is sprayed into the nose, rather than by injection as with other licensed influenza vaccines, where it induces protective immunity.
In the US, LAIV is marketed under the trade name FluMist. The vaccine included in the MAA has not been registered in the EU and is not available outside of the US.
Alex Zukiwski, executive vice president of clinical affairs and chief medical officer of MedImmune, said: Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world. MedImmune is pleased to submit this application for approval of our nasal spray influenza vaccine in Europe.