SUNDAY, SEPTEMBER 25, 2016

Fluenz Tetra receives positive review in EU

AstraZeneca announced on Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion on Fluenz Tetra, a nasal four-strain live attenuated influenza vaccine.

The positive opinion came after the CHMP reviewed data from a pivotal pediatric study that compared the safety and immunogenicity profile of Fluenz Tetra to the currently approved three-strain vaccine Fluenz.

Now that CHMP has given a positive review of Fluenz Tetra, the vaccine will be reviewed by the European Commission, which has the power to approve medicines for the European Union. If Fluenz Tetra is approved by the EC, it will replace Fluenz for the 2014-2015 season and seasons after it.

"We are delighted that Fluenz Tetra has received a positive opinion from the CHMP," Filip Dubovsky, the vice president of Clinical Biologics Infectious Disease and Vaccines at AstraZeneca, said. "The inclusion of two influenza B strains in the vaccine will provide broad protection and should help to reduce the overall incidence of influenza.:

Seasonal flu vaccines typically have three strains of influenza: the H1N1 influenza A, H3N2 influenza A and influenza B strains. Fluenz Tetra contains the two strains of influenza A along with an additional strain of influenza B, which accounts for approximately 25 percent of the influenza strains in Europe.