Non-Safety Related Recall of Some H1N1 Nasal Spray Vaccines, Pediatric Alliance Says

thermalI received an update about H1N1 virus that was sent to my by my local pediatrician, Pediatric Alliance.

The e-mail stated: “There has been a voluntary recall of specific lots of nasal spray H1N1 vaccine. The recall is due to manufacturer quality assurance measures indicating a decreased potency in some batches of the H1N1 nasal spray vaccine. The Centers for Disease Control (CDC) states that there are no safety concerns. The slight decrease in potency should not affect how the vaccine works, and children who received the doses in question do NOT need to be re-vaccinated.”


The Centers for Disease Control and Prevention gave more information on their website by writing: “First, it is important to point out that the recall is not safety-related. 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.” On December 18 and 21, the manufacturer notified CDC and FDA that the potency in 13 batches (called “lots”) of nasal spray vaccine had decreased below the pre-specified limit or were at risk of falling below that limit within the upcoming week. The vaccine was within the specified range at the time the vaccine was distributed. The slight decrease in potency should not affect how the vaccine works. However, the manufacturer will send providers directions for returning any unused vaccine from these lots.”

Persons who received vaccine for the H1N1 virus from the recalled batches do NOT need to take any action or contact their health care provider.


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