Sanofi Pasteur has recalled four lots of pediatric H1N1 flu vaccine in prefilled syringes after finding that doses in these lots no longer meet potency specifications, the Centers for Disease Control and Prevention announced today. Children who received vaccine from these lots do not need to be revaccinated, because the small decrease in antigen content is unlikely to result in a significant reduction in immune response, CDC said.
Vaccine providers should return any unused vaccine from the lots to the manufacturer. Shipped in November, the recalled lots are intended for children 6-35 months old.
The affected vaccine met all specifications at the time of release. The CDC and Food and Drug Administration have determined that there are no safety concerns for children who received the vaccine.
For more information, visit www.cdc.gov/h1n1flu/vaccination.
[ via AHA News Now ]