Health Advisory - Non-Safety Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Vaccine in Pre-filled Syringes

To: H1N1 Vaccination Sites
From: Wendy Davis, MD, Commissioner
Date: February 1, 2010

The Centers for Disease Control & Prevention (CDC) sent out notification regarding the voluntary recall of five lots of Sanofi Pasteur H1N1 pediatric vaccine in 0.25 mL pre-filled syringes for use with 6- to 35-month-old children, and one lot of 0.50 mL single-dose pre-filled syringes for use with older children and adults. 

Due to antigen content lower than required potency levels, the manufacturer is conducting a non-safety related voluntary recall of the affected vaccine lots. CDC and the Food & Drug Administration are in agreement that the small decrease in antigen content is unlikely to result in a clinically significantreduction in immune response among persons who have received the vaccine.

For this reason, there is no need to revaccinate children who have received vaccine from these lots.

Practices that received this vaccine as a direct shipment from McKesson will receive information by mail on how to return unused vaccine. Practices that received this vaccine through a transfer from another provider site, or from a Vermont Department of Health district office should dispose as medical waste. In either instance, please account for these doses as waste on your H1N1 Vaccine Accountability and Order Form.

The only vaccine affected by this recall is identified by the following lot numbers:

If your practice has any questions or concerns about this recalled vaccine, please contact the Immunization Program at (802) 863-7638 or immunizationprogram@vdh.state.vt.us

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