Non-Safety Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes
To: Vermont Health Care Providers
From: Wendy Davis, MD, Commissioner
Date: December 16, 2009
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Yesterday the Centers for Disease Control & Prevention (CDC) distributed a Health Alert Network (HAN) notice regarding the voluntary recall of certain lots of Sanofi Pasteur H1N1 pediatric vaccine in 0.25 mL pre-filled syringes for use with children age 6 months through 35 months old.
Vermont received an estimated 600 doses from the affected lots, and the Vermont Department of Health has notified hospitals and health care providers that were shipped vaccine from these lots.
None of this vaccine went to school clinics.
The recalled vaccine lots are safe. The reason for the recall is the vaccine potency.
Providers are being asked to return any vaccine to the manufacturer because of potency levels that are lower than required. While the antigen content of these lots is below the required specification,
CDC and the U.S. Food & Drug Administration agree that the small decrease in antigen content is not likely to result in a significant lack of immunity among vaccinated patients.
For this reason, children who received vaccine from these lots do not need to be revaccinated, but they do need to receive two doses of H1N1 vaccine to be fully protected – in accordance with current ACIP recommendations.
For more detailed information in the form of Qs and As from CDC, go directly to: http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
If your practice has any questions or concerns about this, contact the Immunization Program at (802) 863-7638 or E-mail: firstname.lastname@example.org.