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MedImmune Monovalent 2009 (H1N1) influenza nasal spray vaccine - shortened shelf life of certain lots
  • Published Date:
    12/23/09
  • Source:
    HAN ; 304
  • Language:
    English
Filetype[PDF - 960.38 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
  • Description:
    Wednesday, December 23, 2009, 09:20 EST (9:20 AM EST)

    CDCHAN-00304-2009-12-23-UPD-N

    MedImmune announces limited, voluntary, non-safety-related recall o f remaining unused product.

    On December 18 and 21, MedImmune notified CDC and FDA that the potency of 13 lots of monovalent 2009 (H1N1) nasal spray vaccine had decreased below a pre-specified limit or were at risk of falling below that limit in the next week. This slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety. However, because their potency is now or might soon be below the specified lower limit, MedImmune will send providers directions for returning any unused vaccine from these lots.

    The potency of these lots is now or might soon be slightly below the specified range for the product. CDC and FDA are in agreement that the slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. For this reason, there is no need to revaccinate persons who have received vaccine from these lots.

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