Sanofi Recalls 800,000 Doses of H1N1 (Swine) Flu Vaccine for Children

December 16, 2009

Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.

Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.
 
After a routine stability testing,  Sanofi learned that this vaccine's potency was 12% below the point where it should have been.  Sanofi 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.
 
This vaccine, which was manufactured in Sanofi’s factory in Swiftwater, PA, was distributed throughout the US. Vaccine doses with the following lot numbers are included in the recall:
• 0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB.
• 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.
 
According to the CDC, there is no safety concern and even though the vaccine isn't quite as potent as it is supposed to be, children vaccinated from the lots already will not need to be re-vaccinated.
 
This fall, the FDA approved four H1N1 flu vaccines, manufactured by CSL Limited, MedImmune, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur. In November, the FDA approved a fifth vaccine, manufactured by GlaxoSmithKline (GSK).
 
Last month, GSK put on hold one lot of its Arepanrix adjuvanted H1N1 flu vaccine in Canada, following reports of a higher than usual number of adverse events.

Questions and answers related to Sanofi’s vaccine recall on CDC’s web site