Some H1N1 vaccines are recalled

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December 17, 2009

By GINA KINSLOW The Glasgow Daily Times Thu Dec 17, 2009, 12:23 PM CST

A non-safety related recall of the H1N1 vaccine has been issued.

The Kentucky Cabinet for Health and Family Services received notice Tuesday that Sanofi Pasteur, the manufacturer of H1N1 vaccine found four distributed slots of single-dose, pre-filled syringe pediatric vaccine with antigen content lower than required potency levels.

“Kentucky received a total of 21,800 doses in prefilled syringes shipped to providers statewide,” said Barbara Fox, public information officer, Kentucky Outreach and Information Network. “We have provided the lot numbers to our local health departments so that they can track down the implicated lots themselves. The State Department for Public Health will also notify all providers directly to make sure that the lots are recovered.”

Fox also stressed that the alert is only a potency issue and not a safety issue.

“The antigen content of the implicated vaccine tested above the specification limit when produced but fell slightly below that limit on later testing,” she said, adding that Centers for Disease Control and Prevention determined the reduction is small enough that there is no need to revaccinate children who were vaccinated with recalled lots, but that children under 10 still need two doses of H1N1 vaccine.

Crissy Rowland, health information branch manager for the Barren River District Health Department in Bowling Green, said some of the vaccine was sent to the health department in Glasgow.

“We had 100 doses of these particular lot numbers in Barren County,” she said. “The remaining doses have been pulled.”

Rowland stressed there are no safety concerns with the recalled lots of 2009 H1N1 vaccine.

“All lots successfully passed pre-release testing for purity, potency and safety,” she said. “Only specified lots of the 2009 H1N1 pediatric vaccine for children 6-35 months in pre-filled syringes are affected. There is no need to readminister a dose to those who received vaccine from these lots. The vaccine potency is only slightly below the ‘specified’ range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen.”

Rowland also stated that all vaccines are routinely tested for purity, potency and safety prior to release.

“The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers,” she said. “The vaccine provided in multi-dose vials and the single dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications.”

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Some H1N1 vaccines are recalled

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