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FDA clears Sanofi to compete for 4-in-1 flu vaccine market

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The 2013-14 flu season is set to be the most closely watched in years. In February, FDA cleared the use of quadrivalent vaccines which protect against two A and two B strains. GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) began gearing up, and Sanofi ($SNY) will now join them too.

FDA approval of Sanofi's 4-in-1 flu vaccine arrived this week, clearing the company to compete against GSK and AstraZeneca's biotech unit, MedImmune. With each offering protection against the same strains, the manufacturers are differentiating their vaccines through features and label restrictions. MedImmune's vaccine is delivered nasally, while Sanofi is set to benefit from an FDA label that allows administration to kids from 6 months of age and up. MedImmune's and GSK's vaccines are only cleared for use in kids from 2 and 3 years old, respectively.

This means Sanofi has the only vaccine approved for use in children younger than 2, a population that has the highest risk of severe flu-related complications. Sanofi Pasteur VP of scientific and medical affairs Dr. David Greenberg told FiercePharma: "Children and young adults seem to suffer disproportionately from influenza, with more hospitalizations and deaths, so it is very significant that we have a vaccine for children of this age."

The U.S. Centers for Disease Control and Prevention recommends that everyone aged 6 months and up is vaccinated against the flu. However, only around two-fifths of people currently receive the jab each year. Those who do get vaccinated should receive better protection from the 4-in-1 products. Since 2000, vaccines have only protected against the dominant B strain in 50% of flu seasons. The 4-in-1 vaccines offer protection against two B strains, increasing the likelihood of immunity against the flu viruses circulating in any particular year.

- here's the FiercePharma article
- check out Reuters' piece

Special Report: Sanofi - Top 5 Vaccine Companies by Revenue - 2012

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