Health Alerts > 12/15/09 H1N1 update

H1N1  National Info

As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one lot of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. Because 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.   This recall is NOT due to safety concerns.  According to the CDC and FDA, there is also no need to re-vaccinate persons who have received the vaccine from these lots.  Indiana received about 10,000 doses of the affected lots,

Indiana received about 10,000 doses of the affected lots, of which about 500 doses were sent to Allen County. Of that number, only about 20 doses were actually administered locally and we have been in contact with that provider.  Therefore, if you have parents call, you can assure them that your facility did not receive any of the H1N1 vaccine that was recalled today.

Again, 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. 

State Info

The Indiana State Department of Health has opened up the vaccine to all patients, so please feel free to distribute to patients, staff and their families as you see best.