December 15, 2009: H1N1 Flu Vaccine Recall

Recall Reason

The US Centers for Disease Control and Prevention (CDC) announced a non-safety-related recall of approximately 800,000 doses of pediatric H1N1 flu vaccine after voluntary tests indicated they may not be potent enough to protect children against the swine flu virus.

The recall involves pre-filled syringes intended for young children, ages 6 to 35 months, from certain lots manufactured by Sanofi Pasteur and distributed throughout the United States. Health officials report that it's not clear how many doses have already been given, but they don't think children need to be re-vaccinated.

Click here to read the CDC's Q&A about the recall.

What Should Parents Do?

According to the CDC, parents of children younger than age 10 who received the vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series as scheduled. The vaccine in these lots has a potency only slightly below the "specified" range and is still expected to stimulate a protective response. There is no need to re-administer a dose to those who received vaccine from these lots.

The CDC adds that there are no safety concerns with these lots of H1N1 vaccine, which all successfully passed testing for purity, potency, and safety when they were first shipped. As part of its quality assurance program, Sanofi Pasteur performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers because sometimes the strength of a vaccine can go down over time.

Were All H1N1 Vaccines Impacted?

No. The potency problem described here is specific to four lots of Sanofi Pasteur's pediatric H1N1 vaccine in 0.25 mL pre-filled syringes. The same vaccine packaged in other dosing forms, such as pre-filled syringes for older children, adults, and multi-dose vials, continues to meet specifications. This recall does not affect H1N1 vaccine produced by other manufacturers.