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Pediatric doses of H1N1 vaccine recalled

The Kent County Health Department assured the public Tuesday that the hundreds of doses of the pediatric H1N1 vaccine that were recalled by the manufacturer do not pose a threat to the children vaccinated.

According to KCHD spokesperson Bridie Bereza, the vaccine, which was created for children ages 6 months to 35 months, was recalled due to slightly lower than specified potency levels. The problem was found by manufacturer Sanofi Pasteur during a routine stability inspection of several lots that had already been shipped.

“Vaccine manufacturers routinely test flu vaccines after they go out to health care providers to ensure that vaccines continue to meet required standards,” explained Bereza.

According to the Centers for Disease Control, the dose met standards at the time it was filled but lost its potency, falling just below the manufacturer’s specification levels.

Both the Food and Drug Administration and the CDC said that children vaccinated with the recalled doses are in no danger and do not need to be revaccinated.

The Kent County Health Department received 400 of the recalled doses of vaccine. Of those, 130 had been sent to health care providers in Kent County. The other 270 doses were designated for use at KCHD. The 270 doses designated for use at KCHD have not been administered and will be sent back to the manufacturer.

Larger area health care providers may also have received some of the recalled doses directly from McKesson, the vaccine distributor.

The CDC and the vaccine manufacturer, Sanofi Pasteur, are managing outreach to 
impacted providers.

Lot numbers of affected doses are recorded on the information card given to clients at the time of vaccination. Affected lots include UT023DA, UT028CB, and UT030CA. Those concerned about the recall can check their card to see if they received a recalled dose.

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