Health Alert
SANOFI PASTEUR MONOVALENT 2009 (H1N1) INFLUENZA VACCINE IN PRE-FILLED SYRINGES - SHORTENED SHELF LIFE IN CERTAIN LOTS

The Delaware Division of Public Health (DPH) is forwarding this health alert from the Centers for Disease Control and Prevention. For more information from the Division of Public Health, contact the immunization program at 1-800-282-8672.

Summary: Sanofi Pasteur has notified CDC and FDA that some lots of monovalent 2009 (H1N1) influenza vaccine in prefilled syringes will have a shorter expiration period than indicated on the label. The lots of Sanofi Pasteur monovalent 2009 H1N1 influenza vaccine in prefilled syringes should be used by February 15, 2010, as indicated in the table below regardless of the expiration imprinted on the package. This is to ensure that the vaccine is used while it remains within its potency specification. There are no safety concerns with these lots of 2009 H1N1 vaccine. People who received vaccine from the lots listed below with shortened shelf life do not need to take any action.

Background

As part of its quality assurance program, Sanofi Pasteur performs routine, ongoing stability testing of the vaccine after it has been shipped to providers. Stability testing means measuring the strength of a vaccine over time.

The 50 lots subject to this change in expiration date include approximately 12 million doses. These lots were shipped to providers between November 2009 and January 2010. Although these lots remain potent, they are losing their potency more rapidly than expected, and therefore the shelf life is being shortened. While most of the doses from these lots are believed to have already been administered, there are almost certainly some doses that have not yet been used.

The change in expiration date described here is specific to the 50 lots of Sanofi Pasteur 2009 H1N1 influenza vaccine in pre-filled syringes listed below. However, a related recall (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306) was conducted recently, which involved lots from Sanofi Pasteur’s 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. These actions do not affect Sanofi Pasteur’s 2009 H1N1 vaccine in multi-dose vials.

Sanofi Pasteur will send a notification to providers who received doses from any of the 50 lots of vaccine described below.

Lot Information

These lots should be used by February 15, 2010, as indicated in the table below regardless of the expiration date imprinted on the package.

All pre-filled syringes that have not been used by February 15, 2010 should be discarded in an appropriate manner, or you may return the product for destruction to Sanofi Pasteur Inc., c/o Capital Returns at 6101 N. 64^th Street, Milwaukee, WI 53218.

DPH has determined that of the affected vaccine, the lot numbers listed below were delivered to providers in Delaware. DPH will send notifications to those providers that did not receive the vaccine directly from the CDC distributor McKesson. As indicated above, Sanofi will send notifications to those providers that received the vaccine directly from McKesson.

Table 1:Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes.
Expiration Date Change.Lot #’s received in Delaware

Table 2: Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes. Expiration Date Change

For More Information:

Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, is available 24 hours a day, every day.

For other inquiries, please contact Sanofi Pasteur Customer Services: 1-800-VACCINE (1-800-822-2463) or visit www.vaccineshoppe.com

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