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Harford County Health Department ~  120 S. Hays Street ~ Bel Air, Maryland 21014 ~ Phone: 410.838.1500 ~ Fax: 410.638.4952

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HARFORD COUNTY HEALTH DEPARTMENT
 
120 S. Hays Street P.O. Box 797 Bel Air, MD 21014

DATE:December 23, 2009
CONTACT: Bill Wiseman, Public Information Officer, 410-612-

LIMITED H1N1 FLUMIST RECALL DOES NOT EFFECT THOSE RECEIVING VACCINE FROM HARFORD COUNTY HEALTH DEPT.
 

Bel Air, MD - December 23, 2009 -  On Tuesday evening, December 22, 2009, MedImmune, the manufacturer of H1N1 FluMist vaccine, announced a non-safety related recall of 13 batches (referred to as "lots") of live attenuated (LAIV) "nasal mist" influenza vaccine.

The Harford County Health Department received several shipments containing portions of these FluMist lots during October.  However, the Department administered them shortly after receiving it, when manufacturer testing determined that the supply had an acceptable level of potency.

This recall never was associated with any safety risk and revaccination is not recommended for persons who received one from any of the implicated LAIV lots.  

As part of its quality assurance program, the manufacturer of the nasal spray monovalent 2009 H1N1 flu vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine. Stability testing means measuring the strength (also called potency) of the vaccine over time to make sure it does not go below a pre-specified limit during the vaccine's "shelf life."  In this instance, the manufacturer determined on the basis of weekly testing that vaccine which was produced with adequate potency, had decreased in strength over time.

The "health effects" section of the recall states that the vaccine that was administered in October and November fully met potency requirements.  According to the National Centers for Disease Control, there are no safety concerns with these lots of 2009 H1N1 vaccine since all lots successfully passed pre-release testing for safety, purity and potency.  The vaccine was within the specified potency range at the time the vaccine was distributed and the slight decrease in strength should not affect how the vaccine works. The recall has been issued in the event some doses, still in storage might not yet have been administered.

To access the national Centers for Disease Control and Preventions question and answer page, visit their website at http://www.cdc.gov/h1n1flu/vaccination/sprayrecall_qa.htm.  For more information, visit Harford County Health Department website at www.harfordcountyhealth.com or call 410-612-1781.
 
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