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FDA Clears Sanofi Four-Strain Flu Vaccine for Adults, Kids

Inspecting vaccine vials (Sanofi Pasteur)

Inspecting vaccine vials (Sanofi Pasteur)

Sanofi Pasteur, the vaccine division of the global pharmaceutical company Sanofi, says the Food and Drug Administration cleared for sale in the U.S. its Fluzone Quadrivalent vaccine that covers four influenza strains. The FDA action, says the company, will make the vaccine available for infants, adolescents, and adults.

The Centers for Disease Control and Prevention (CDC) recommends annual flu vaccinations for everyone six months and older. In the last flu season, from October 2012 through April 2013, CDC reported 12,343 hospitalizations from flu, or 44.3 hospitalizations per 100,000 people in the U.S.

The FDA action is an approval of Sanofi Pasteur’s biologics license application for the product. Until this year, most seasonal flu vaccines were trivalent, containing inactive viruses of the three influenza strains most likely faced in a particular flu season. The vaccines covered two A and one B type viruses

Starting this year, quadrivalent vaccines, covering two strains each of A and B type flu viruses are being made available. The addition of another B strain is needed, says Sanofi Pasteur, because of more than one B type viruses in circulation, which made it difficult for public health authorities to plan for an effective vaccine formulation for the upcoming season.

The company says its quadrivalent vaccine will be available in the U.S. for the 2013-2014 flu season, in prefilled syringes or single-dose vials for intramuscular administration. The CDC lists eleven vaccine products available for the 2013-2014 season, including two other quadrivalent vaccines by GlaxoSmithKline and MedImmune.

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Hat tip: FirstWord Pharma

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