Thursday, December 17, 2009

Safety Not a Concern in H1N1 Vaccine Recall

The voluntary recall of certain children's H1N1 vaccine by the vaccine manufacturer is not related to the vaccine's safety, and that this and all forms of the vaccine remain very safe, according to State Health Officer Jimmy Guidry.

Vaccine manufacturer Sanofi-Pasteur announced today that it is recalling four lots totaling about 800,000 doses of pre-filled syringes of H1N1 vaccine intended for use with children aged six months through 35 months. Louisiana vaccine providers have received about 10,900 doses of this particular form of vaccine, however, only 610 doses from the recalled lots have been administered statewide.

The lots were voluntarily recalled by the manufacturer after routine post-shipping tests of the vaccine found the vaccine to be slightly less potent than the manufacturer's license stipulates. However, even when just 20 percent as potent as called for, vaccines can still generate the needed response from the immune system. These lots of vaccine were found to be 88 percent as potent as specified. Therefore, there is no need to revaccinate those who received the slightly less potent vaccine.

"Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed," Dr. Guidry said.

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