15,000 children's swine flu vaccine recalled for ineffectiveness

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Children's swine flu vaccine recalled for ineffectiveness

By Luis Fabregas
PITTSBURGH TRIBUNE-REVIEW
Tuesday, December 15, 2009
Last updated: 3:42 pm

A nationwide recall of swine flu vaccine for infants today extended to Pennsylvania, where vaccine maker Sanofi-Aventis recalled about 15,000 of the pre-filled syringes.

Holli Senior, a spokeswoman for the Pennsylvania Department of Health, said 20 providers throughout the state received the recalled doses, but she did not immediately know specific locations.

Sanofi-Aventis recalled about 800,000 doses, saying the vaccine may be less potent than required. Officials at the U.S. Centers for Disease Control and Prevention emphasized the vaccines were safe.

"It's a potency issue, not a safety issue," Senior said.
If children have received the vaccine it would not pose any safety concerns, she said.

The infants and children who received the recalled vaccine should be protected from the H1N1 virus, provided they received the recommended two shots, said Dr. Anne Schuchat of the Centers for Disease Control and Prevention.

Len Lavenda, spokesman for Sanofi-Aventis, said the vaccine should still protect children who received two doses.

"We still believe it will protect children," he said.

He said routine tests showed four lots of the vaccine contained "a little less antigen" and "little less active ingredient" than required. Sanofi-Aventis notified federal authorities of the problem on Monday.

Since the recalled vaccine most likely was already given to children, officials issued the recall to alert providers to return any unused doses.

http://www.pittsburghlive.com/x/pittsburghtrib/news/nation/s_657858.html

 

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Re: 15,000 children's swine flu vaccine recalled for ineffectiveness

Hanover Hospital clinic gave out recalled H1N1 vaccines
An official said the H1N1 vaccine doses aren't harmful but are less potent.
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By KATE WILCOX
For the Daily Record/Sunday News
<!--date-->Updated: 12/15/2009 10:28:12 PM EST
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The H1N1 vaccine that children ages 6 months to 35 months old received Saturday at a Hanover vaccine clinic are part of a batch of 800,000 pre-filled syringes recalled by the Centers for Disease Control and Prevention on Tuesday, according to Hanover Hospital.

The recalled vaccine is not harmful, stressed Lisa Duffy, director of marketing at Hanover Hospital. It simply is less potent, she said. No action needs to be taken by parents, Duffy said, except to bring their children in for already-scheduled booster shots.

The community clinic, held at Pennville Fire Station, distributed vaccines to priority groups 6 months to 5 years old and adults between the ages of 25 and 64 years old with chronic medical conditions. On the day of the clinic, the hospital also opened the clinic to walk-ins because of low registration numbers.

About 73 children in the Hanover area registered to receive the recalled vaccine made by Sanofi Pasteur -- the vaccines division of France-based Sanofi-Aventis Group.

Last week, testing of one lot of the vaccine showed the potency had fallen about 12 percent below the government standard, said Len Lavenda, a Sanofi Pasteur spokesman.

The adult vaccines and those given to 3- and 4-year-olds at the community clinic were from different companies, Duffy said, and were not recalled.
Officials with the Food and Drug Administration, the CDC and the company that made the vaccine, all said they believe the strength of the recalled doses is still high enough to protect children against the virus.

http://ydr.inyork.com/ci_14005135