US clears HIGH-DOSE Sanofi flu vaccine for elderly

Reuters
December 25, 2009

WASHINGTON – U.S. health officials approved on Wednesday a high-dose influenza vaccine made by Sanofi-Aventis DA (SASY.PA) for people age 65 and older.

The vaccine uses a higher dose to produce a stronger immune response and better protect the elderly against seasonal flu, the Food and Drug Administration said.

The vaccine will be available for immunizing people in the fall of 2010 ahead of the next flu season, said Sanofi Pasteur, the company’s vaccine unit.

The FDA said “non-serious” events such as redness and injection-site swelling were more frequent with the high dose vaccine. The rate of serious problems was comparable with Sanofi’s regular-dose Fluzone.

The new vaccine was approved based on studies showing a stronger immune response compared with the original Fluzone. The company must conduct further studies to verify the high dose version decreases seasonal flu after vaccination, the FDA added.

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