AstraZeneca is first to win EU approval for an inhaled 4-in-1 flu vaccine

AstraZeneca ($AZN) has gotten EU approval for its inhaled, four-in-one flu vaccine for children. Fluenz Tetra is among a new generation of treatments that are expected to carry premium prices and so boost the revenues companies will generate from a part of the market once considered a backwater.

The U.K. company's new vaccine is approved for children and adolescents from 24 months up to 18 years of age. It has the further advantage of being the first intra-nasal four-strain influenza vaccine available in Europe that doctors can turn to for use in children afraid to be vaccinated by needles. AstraZeneca said Fluenz Tetra will replace its Fluenz three-strain (trivalent) live attenuated influenza vaccine starting with the 2014-2015 flu season. The vaccine, marketed in the U.S. as FluMist Quadrivalent, was approved by the FDA in 2012 for ages 2 to 49.

Historically, seasonal flu vaccines have contained two influenza A viruses and one influenza B virus. The newer vaccines carry a second influenza B strain. AstraZeneca says that in the last 10 years, the second B virus has accounted for 25% of the strains circulating in Europe.

With the added protection comes higher pricing. Vaccine partners Sanofi ($SNY) and Merck ($MRK), the largest vaccine makers globally, expect their new four-strain shot to price at least 50% higher than with its three-strain vaccines. Analysts have forecast sales of the new shot to bring in $384 million annually by 2022. GlaxoSmithKline ($GSK) is selling its new quadrivalent Fluarix to the U.S. Centers for Disease Control and Prevention (CDC) for $12.03 per dose, a 50% premium over its three-strain vaccine. Analysts think it will take a few years for the four-strain vaccines to become the standard. When they do, they project the market will grow more than 5% a year, rather than in the lower single digits.  

- here's the announcement

Special Reports: Top 10 Best-Selling Flu Vaccines of 2012 | Top 5 Vaccine Companies by 2012 Revenue - Sanofi - GSK

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