Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Pediatric Vaccine

As part of its quality assurance program, Sanofi Pasteur, performs routine, ongoing stability testing of its 2009 H1N1 vaccine after the vaccine has been shipped to providers. Stability testing measures the strength/potency of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (also called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. A total of 800,000 vaccines have been recalled.

There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety. Infants and children who received vaccines from these lots do not need to be revaccinated because the vaccine potency is only slightly below the “specified” range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.

Source: CDC http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm