The Centers for Disease Control and Prevention notified doctors about the recall Tuesday. The recall involves about 800,000 doses made by Sanofi Pasteur. The doses are pre-filled syringes intended for young children, ages 6 months to almost three years.
Health officials recommend children those ages get two doses, spaced about a month apart.
Health officials say it’s not clear how many doses have already been given, but they don’t think children need to be re-vaccinated. The lots passed potency tests when they were first shipped, but tests indicate the potency waned after.
Sanofi Pasteur released the following statement Tuesday:
Sanofi Pasteur is recalling four lots of pediatric Influenza A (H1N1) 2009 Monovalent Vaccine because routine testing measured lower antigen content than the specification limit. These lots passed all quality controls and met all specifications required by government agencies at the time of shipping. There are no safety concerns related to this action.
These lots of vaccine were manufactured by Sanofi Pasteur and administered to infants 6 through 35 months of age for protection against the 2009 pandemic influenza A (H1N1) virus. The affected vaccine is identified by the following lot numbers:
The vaccine was first shipped on September 29, 2009.23