800,000 swine flu doses recalled
Luis Fabregas is a Pittsburgh Tribune-Review staff writer and can be reached at 412-320-7998 or via e-mail.
Pennsylvania health officials Tuesday defended the safety of recalled swine-flu shots for children and said parents don't need to do anything if their children received the recommended two doses of the vaccine.
"It's a potency issue, not a safety issue," said Holli Senior, a spokeswoman for the state Department of Health. "If individuals have received the vaccine, it wouldn't create an unsafe condition because it's a non-safety recall."
Sanofi-Aventis, one of the major makers of H1N1 vaccine, recalled about 800,000 doses across the nation that were meant for children ages 6 months to 3 years. The vaccine maker recalled 15,100 pre-filled syringes in Pennsylvania.
Senior would not release the names of 20 providers in the state that received the recalled doses, and would not say whether any of them are in Western Pennsylvania.
"It would be at the discretion of the provider to reach out to patients if they felt that was necessary," she said. The state allocated about 3.2 million doses of the vaccine to more than 1,500 doctors, hospitals and schools.
The recalled vaccine was not used at Children's Hospital of Pittsburgh of UPMC, said spokesman Marc Lukasiak. Officials at Children's Community Pediatrics, the largest group of pediatricians in the region, did not return calls seeking comment.
Routine tests showed four lots of vaccine contained "a little less antigen" and "little less active ingredient" than required, said Sanofi spokesman Len Lavenda. The company said the vaccine passed safety tests before shipment and notified federal authorities about the problem Monday.
"There's no safety concern whatsoever," Lavenda said.
Infants and children who received the recalled vaccine should be fully protected from the H1N1 virus, provided they received the recommended two shots, said Dr. Anne Schuchat of the Centers for Disease Control and Prevention in Atlanta. The doses are supposed to be spaced two months apart.
Health officials don't believe children need to be vaccinated again, even if they got two doses from recalled lots, said Schuchat. The vaccine might have lost potency while in storage.
Swine flu vaccine became available in early October, and since then ,manufacturers released about 95 million doses for distribution in the United States. The recalled vaccine is the only thimerosal-free version. Thimerosal is a preservative federal authorities consider harmless, but vaccine critics blame it for autism and other diseases.
Since the recalled vaccine most likely was given to children, officials issued the recall to alert providers to discard any unused vaccine.
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