Sanofi Recalls 800,000 Swine Flu Shots

Tom Randall
December 15, 2009

Sanofi-Aventis SA recalled 800,000 doses of swine flu vaccine after testing showed the potency of the batches was too low, the U.S. Centers for Disease Control and Prevention said in a statement today.

Doctors who have unused shots from the batches should return them, the CDC said today. The shots remain safe, and people who have already been inoculated don’t need to get revaccinated, according to the Atlanta-based agency.

The shots passed potency tests when they first shipped, and their potency dropped in subsequent tests by 10 to 12 percent, said Anne Schuchat, head of the National Center for Immunization and Respiratory Diseases at the CDC, in a telephone interview.

The recalled shots are preservative-free syringes of a low- dose version made for children ages 6 months through 25 months, she said. There are no remaining preservative-free shots available for children under 2 years old. The preservative, called thimerosal, has been shown repeatedly in studies to be safe, though some parents are wary of it, Schuchat said.

Sanofi said it began delivering swine flu vaccine in the U.S. in September, with the bulk of deliveries expected in the fourth quarter.

Sanofi’s vaccine sales totaled 1.05 billion euros ($1.5 billion) in the third quarter, including 78 million euros from H1N1 influenza shots. In October, the Paris-based company forecast that sales of H1N1 vaccine would surge to about $500 million in the fourth quarter. The company plans a seminar Dec. 17 to brief investors and analysts on the vaccine business.

Swine flu infected 50 million people in the U.S. and killed an estimated 10,000 through Nov. 14 from the start of the pandemic in April, the CDC said on Dec. 10. Swine flu, known as H1N1, was first identified in April and swept the globe at an unprecedented rate before cases declined in the U.S. in the past few weeks. In a typical season, 36,000 people die of the flu.


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