800,000 Swine Flu Vaccines Recalled Due to Fading Potency

Health officials have recalled 800,000 doses of swine flu vaccine for children because tests indicate the vaccine doses lost some strength and may not be potent enough to protect against the virus, federal officials said today.

The Centers for Disease Control and Prevention issued an alert about the recall (four lots of pediatric H1N1 swine flu vaccine) Tuesday morning, notifying doctors about the recall and saying that the vaccine was fine when it was distributed across the country, but its potency apparently faded during a month of storage. Why the potency deterioration isn’t clear.

The recall involves hundreds of thousands of doses of swine flu made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group (SNY). The tests on the doses, which are prefilled syringes intended for young children, ages 6 months to almost 3 years, showed that the vaccines’ strength had fallen slightly below required levels.

The CDC said the four lots were discovered as part of a quality assurance testing program and that the company had also notified the U.S. Food and Drug Administration.

Health officials stressed that parents don’t need to do anything or to worry. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, says there’s no safety concern here, because demand for the vaccine is so great that the doses were most likely administered before its potency faded.

Last week the CDC said 85 million doses of the vaccine had been made available for distribution so far.