Vaccine Recall:
About 10,990 doses of pediatric swine flu vaccine shipped to Louisiana are among the 800,000 doses being recalled nationwide after a French manufacturing company said tests show the vaccine may have lost some of its strength.State health officials, however, were quick to tell parents Tuesday that there is no safety issue involved in the recall.
Tests administered by Sanofi Pasteur, the French vaccine manufacturer, found that four lots of vaccine shipped to the U.S. and designated for children from ages 6 months to almost 3 years have lost some potency.
After checking records, Louisiana Department of Health and Hospitals officials found that 684 doses of the recalled vaccine were administered to children in the state, said René Milligan, a DHH spokesman
Milligan said he did not yet know which providers in the state had received the now recalled vaccine.
The vaccine, which came in pre-filled syringes, was shipped straight to providers from the federal government’s national distributor, McKesson.
“It’s probably at a variety of providers,” Milligan said, estimating that between 36 and 110 providers statewide might have received the vaccine.
Milligan said parents should understand there is no safety factor involved in the recall.
“Parents do not need to take any action on this,” Milligan said. “There is no need to re-administer the dose of vaccine to their children.”
Children ages 6 months to 10 years require two doses of the vaccine before they are considered protected, Milligan said.
Once these children have the two doses of vaccine, they will be protected — even if one of the doses is from the lots that have been recalled, Milligan said.
“The change in the vaccine (being recalled) is so slight that it is still expected to be effective in stimulating a protective response,” Milligan said.
The vaccine was tested before it was shipped to the U.S. by Sanofi Pasteur, Milligan said.
The company then performed routine tests on the vaccine again after it arrived in the U.S. and discovered that it had lost some strength.
“The vaccine is routinely checked for purity, potency and safety,” Milligan said.
The French company still does not know why the vaccine lost some of its potency, Milligan said.
Providers who received the vaccine from the lots being recalled will be given instructions by the company on how to return the unused vaccine.
So far, about 800,000 doses of vaccine have been shipped to Louisiana, Milligan said.
More than 220,000 doses have been given to residents.
“The vaccine has proven to be safe and effective,” Milligan said. “And there are no safety concerns with any of the vaccine.”
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