AstraZeneca has announced that the European Commission (EC) has granted marketing authorisation to its nasally administered four-strain flu vaccine Fluenz Tetra.
The company said in a press release today that the approval makes the vaccine, aimed for the prevention of influenza in children and adolescents from 24 months to 18 years of age, the first and only intra-nasal four-strain influenza vaccine available in Europe. In the past, flu vaccines have only contained three strains of flu, comprising two influenza A viruses and one influenza B virus. Fluenz Tetra, however, contains an additional influenza B strain, AstraZeneca explained, adding that influenza B strains have accounted for around 25 percent of the flu strains circulating in Europe.
“Fluenz Tetra represents the next generation of influenza vaccine and we are pleased that it is now approved in Europe,” said Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines at AstraZeneca’s global biologics research and development arm. “The inclusion of a second influenza B strain will broaden the coverage of Fluenz Tetra and should have a valuable public health impact,” he added.
The EC approval is based on data from a recent paediatric study, which showed a similar safety and immunogenicity profile to the three-strain Fluenz vaccine that has already been approved in Europe. The EC decision also follows a positive opinion from the Committee for Medicinal Products for Human Use in September.