AstraZeneca's marketing authorisation application (MAA) for Fluenz Influenza vaccine (Live attenuated, nasal), a nasally administered live attenuated influenza vaccine (LAIV) for prevention of seasonal influenza, has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
AstraZeneca said that the CHMP issued its opinion for marketing Fluenz Influenza vaccine in Europe for children 24 months to less than 18 years of age.
AstraZeneca’s Fluenz received positive opinion from CHMP based on the results from 73 global clinical studies and US post-marketing studies which included objectives such as clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.
MedImmune executive vice president and chief medical officer Alex Zukiwski said that they are hopeful that the future availability and product characteristics of this new nasal spray influenza vaccine would reduce the spread of influenza.