Tuesday, December 15, 2009

H1N1 Pediatric Vaccine Recall

The Centers for Disease Control and Prevention (CDC) announced this morning the voluntary recall of 800,000 doses of H1N1 (swine) flu vaccine, made by pharmaceutical manufacturer, Sanofi Pasteur.

According to a statement on their Web site, the CDC said, "as part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time."

As a result of these tests, it was determined that four lots of pediatric syringes of the H1N1 vaccine may not be potent enough to protect against the virus. It appears that the lots passed potency tests when they were first shipped, but tests indicated the potency waned after.

According to a statement by Sanofi Pasteur, they are "working closely with the FDA and the CDC to notify those who have administered the vaccine."

There are no safety concerns regarding these recalled vials of vaccine. And, health officials are saying that for children who have been administered the vaccine do not need to be re-immunized except to complete their two-dose immunizations series.

Consult with your health care provider to discuss further any questions you may have.

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