global biologics unit of Astrazeneca, has announced that it has submitted a marketing authorisation application for its nasal spray live attenuated influenza vaccine, which is now being reviewed by the European Medicines Agency, EMEA. The proposed indication in the marketing authorisation application is for prevention of seasonal influenza.
application submission for live attenuated influenza vaccine 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.
attenuated influenza vaccine is formulated to contain three live attenuated influenza virus strains, which are weakened as to not cause illness - Two Type A influenza strains and one Type B strain. The vaccine strains are selected annually by the World Health Organization, WHO, based on anticipated circulating influenza strains for the upcoming season. The vaccine is sprayed into the nose, rather than by injection as with other licensed influenza vaccines, where it induces protective immunity.
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