H1N1 vaccine voluntary recall not a safety issue
Published 7:40 pm Friday, December 18, 2009
H1N1 vaccine manufacturer Sanofi Pasteur voluntarily recalled four lots of pediatric doses that were not as potent as had been specified.
Seven sites in Southwest Health District received some of the recalled vaccine, including two with Public Health.
“The Centers for Disease Control and Prevention determined that the small decrease in antigen content is unlikely to reduce the immune response significantly,” said Southwest Health District Deputy Director Brenda Greene. “The recall isn’t safety-related. There is no need for anyone who received one of the doses to be revaccinated.”
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Greene said Miller County Health Department received 500 doses of the recalled vaccine, and has administered two doses.
Southwest Health District Pharmacy received 100 doses, which went to the Dougherty County Health Department’s General Clinic. Of those 100, 54 doses have been administered.
The other sites in Southwest Georgia that received allotments from the recalled batches include private providers in Moultrie, Sylvester and Albany.
“A total of 115 providers in Georgia received 43,630 affected doses via direct shipment,” Greene said. “They are being notified. The unused vaccine is going back to the manufacturer, who is replacing it.”
The affected vaccine is intended for children six months through 35 months old.
While doing routine quality assurance, Sanofi Pasteur determined that four lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine had a lower antigen content than had been specified, the company announced in a news statement.