Sanofi Pasteur Recalls Pediatric H1N1 Vaccine

Sanofi Pasteur Inc. is recalling about 800,000 doses of its novel influenza A (H1N1) vaccine after four lots of single-dose pediatric vaccine in 0.25 mL prefilled syringes failed stability testing.

The CDC said the four lots of vaccine met specifications at the time of their release and shipment to distribution centers. However, the potency of a vaccine can decline over time. The agency said potency of the recalled lots fell only slightly below the specified range, and there is no need to revaccinate children who have received a dose from those four lots.

"CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine," the CDC said.

The agency added that there are no safety concerns associated with the recalled vaccine, which was intended for children ages 6-35 months.

The CDC said Sanofi Pasteur will notify providers who received recalled vaccine from any of the following four lots:

Providers are asked to return unused vaccine from those four lots to the manufacturer.

The recall does not include Sanofi Pasteur's H1N1 vaccine shipped in multidose vials or single-dose 0.5 mL prefilled syringes.

Meanwhile, the CDC is reminding parents and health care professionals that children younger than age 10 years are recommended to receive two doses of H1N1 vaccine approximately a month apart for the optimal immune response.

The agency also said that children should receive both doses of H1N1 vaccine in the same formulation -- that is, both doses should be the inactivated injectable vaccine or both doses should be the live attenuated nasal spray vaccine.

As of Dec. 15, the CDC said 94.6 million doses of H1N1 vaccine had been made available.