12 million H1N1 Vaccines to Expire Early - Should be administered by February 15, 2010

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12M H1N1 Vaccines to Expire Early

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<!-- JoomlaWorks "Disqus Comment System for Joomla!" Plugin (v2.1) starts here -->Approximately 12 million doses of the Sanofi Pasteur monovalent 2009 (H1N1) influenza vaccine in pre-filled syringes will have a shorter expiration period than indicated on the label, according to a health alert by the Centers for Disease Control and Prevention.

The 50 lots containing the 12 million doses with the shorter expiration periods should be used by Feb. 15, 2010, 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, according to the alert.

All pre-filled syringes that have not been used by Feb. 15, 2010, should be discarded in an appropriate manner, or you may return the product for destruction to Sanofi Pasteur.

See a full list of the affected lots.

http://www.beckersasc.com/news-anal...safety/12m-h1n1-vaccines-to-expire-early.html

 

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Re: 12 million H1N1 Vaccines to Expire Early

Re: 12 million H1N1 Vaccines to Expire Early

Shortened Expiration Period For Sanofi Pasteur 2009 H1N1 Vaccine In Pre-filled Syringes Questions & Answers

February 4, 2010, 10:00 AM ET


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1. Why is Sanofi Pasteur changing the expiration dates of 2009 H1N1 vaccine in pre-filled syringes?
   
   To ensure that its vaccine meets potency standards, Sanofi Pasteur (the manufacturer) is shortening the expiration period of all its 2009 H1N1 influenza vaccine in pre-filled syringes that are not included in either of the two previous Sanofi Pasteur H1N1 vaccine recalls (See Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Vaccine in Pre-filled Syringes Questions & Answers (February 2010) and 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 Questions & Answers (December 2009)).
2. What is the new expiration date?
   
   All lots of monovalent 2009 H1N1 influenza vaccine in pre-filled syringes manufactured by Sanofi Pasteur, not included in the two earlier recalls, should now be administered by February 15, 2010 regardless of the expiration imprinted on the package.
3. What was the original expiration date on these H1N1 vaccines before the manufacturer changed them?
   
   The previous expiration dates were from March to June, 2011.
4. Are there any concerns about the safety of these vaccines?
   
   There are no safety concerns with these lots of 2009 H1N1 vaccine. People who received vaccine from the lots with shortened shelf life do not need to take any action.
5. What lots are affected by this change in dating?
   
   The dating is being shortened on all remaining doses of pre-filled syringes that are not included in either of the two previous Sanofi Pasteur H1N1 vaccine recalls (See Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Vaccine in Pre-filled Syringes Questions & Answers (February 2010) and 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 Questions & Answers (December 2009)
   
   For specific lot numbers, see the official CDC Health Alert Network Update regarding Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine in Pre-Filled Syringes - Shortened Shelf Life of Certain Lots.
   This shortened expiration period along with the two recent recalls (See Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Vaccine in Pre-filled Syringes Questions & Answers (February 2010) and 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 Questions & Answers (December 2009) affects all of Sanofi Pasteur's 2009 H1N1 influenza vaccine in pre-filled syringes that were distributed this season. No additional Sanofi Pasteur pre-filled syringes will be available. However, 0.5 mL pre-filled syringes from Novartis and CSL remain available.
   This shortened expiration period does not affect Sanofi Pasteur?s 2009 H1N1 influenza vaccine in multi-dose vials.
6. How many doses were in these lots?
   
   There were approximately 12 million doses in these lots.
7. What is being done to notify health care providers of this change in dating?
   
   In the week of February 1, 2010, the manufacturer sent notification detailing the change in dating to health care providers who received shipments from the affected lots.

http://www.cdc.gov/h1n1flu/vaccination/qa_expiration.htm