FDA approves Sanofi Pasteur’s supplemental biologics license

FDA approves Sanofi Pasteur’s supplemental biologics license

The United States Food and Drug Administration (FDA) recently approved a supplemental biologics license application for Sanofi Pasteur’s new Fluzone® High-Dose influenza vaccine.

Sanofi Pasteur, a branch of Sanofi that specializes in vaccines, can now include data in its Prescribing Information that shows how Fluzone® High Dose is more effective in adults 65 years and older than the regular Fluzone standard-dose vaccine.

The safety and effectiveness trial was conducted in many large facilities.

The researchers measured that the Fluzone High-Dose vaccine was more than 24 percent more efficient in fighting influenza compared to the regular doses of Fluzone and may even be capable of stopping one in four influenza cases in patients 65 years or older.

Fluzone High-Dose contains more antigens to provoke a stronger immune response from older adults.

"Inclusion of these efficacy data in the Fluzone High-Dose vaccine Prescribing Information validates the importance of this vaccine for people 65 years of age and older," Sanofi Vice President, Scientific & Medical Affairs, and Chief Medical Officer David P. Greenberg, M.D. said. "We are fully committed to helping protect patients from influenza, and we urge everyone eligible — especially older adults — to get vaccinated as soon as possible if they have not already done so."

The study results were originally published Aug. 14, 2014 in The New England Journal of Medicine.

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