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Jun 11, 2013

FDA OKs Sanofi Quadrivalent Flu Vaccine

  • Sanofi’s vaccines division this week received FDA supplemental biologics license application (sBLA) approval for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent. Sanofi Pasteur said this newest addition to its Fluzone range is the first and only four-strain influenza vaccine option for patients as young as six months.

    The firm added that its Fluzone Quadrivalent vaccine includes two A strains and two B strains, and that the 2013 flu season will be the first in which quadrivalent influenza vaccines will be available in the U.S.

    Sanofi said that since the 2001–2002 flu season, two distinct influenza B types have been co-circulating with varying prevalence, making the dominant strain difficult to predict. “Even in years where the correct B lineage strain was selected for the vaccine, some influenza disease was caused by the B lineage omitted from the vaccine likely reducing the overall vaccine effectiveness against circulating influenza viruses,” the firm added.

    Influenza B is a common cause of influenza-related morbidity and mortality in children and has been associated with additional complications, including pneumonia and other respiratory illnesses.

    "Protection against the type B flu strain may be an especially important factor that healthcare providers consider when immunizing children since influenza B causes a substantial number of illnesses, hospitalizations, and deaths in the pediatric population,” Sanofi Pasteur’s David Greenberg, M.D., vp U.S. Scientific and Medical Affairs, said in a statement.



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