Wednesday, December 16, 2009

Recalled H1N1 doses still safe

State says kids who got weakened vaccine don't need new shots By Christina E. Sanchez • THE TENNESSEAN • December 16, 2009 Parents whose children got H1N1 flu shots that were part of a nationwide recall of 800,000 doses of the vaccine do not need to worry and the children are still protected, Tennessee health officials said Tuesday. Sanofi Pasteur, the shot manufacturer, voluntarily recalled the 800,000 doses that were distributed around the country after the company discovered the strength of the active ingredient had decreased. The pre-filled syringes of the recalled vaccine were for children ages 6 months to 35 months. State health officials said Tennessee got 82,600 H1N1 shots from Sanofi for children in those age groups, though they do not know how many would be affected by the recall. But state Health Commissioner Susan Cooper said the vaccine is safe, and parents don't need to do anything even if their child got one — or two — of the Sanofi doses. Children ages 9 and younger need to get two doses of the H1N1 vaccine a month apart to be fully protected against the virus. "Parents do not need to get their child re-immunized," Cooper said. "The vaccine is still effective in generating an immune response in these children." Davidson and Shelby counties' health departments have determined they did not get any of the affected doses. Tennessee providers, as well as providers across the country, have stopped giving the recalled vaccine and will return it to the company once directions on how to do so are released. 12 percent below standard The issue with the recalled doses is the vaccine's strength. Tests done before the shots were shipped — a routine practice — showed that the vaccines were strong enough. But tests done weeks later indicated the strength had fallen slightly below required levels listed on the label. Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, noticed last week that the potency had changed in one lot, or shipment batch, and began testing others. They found four affected lots.Why the potency dropped 12 percent below the government standard isn't clear. "That's the $64,000 question,'' said Len Lavenda, a Sanofi Pasteur spokesman. Dr. Kelly Moore, director of the Tennessee immunization program, said all vaccines undergo routine testing to check for potency changes before and after shipping so providers know when to no longer use a dose. "All vaccines are fragile, and they degrade naturally over time," Moore said. "All of the vaccines are designed with ample amounts of antigen to effect an immune response, so there would still be enough to provide protection." Metro Nashville Health Department officials were fielding calls from concerned parents, said Brian Todd, agency spokesman. "We've let them know we did not administer doses of the recalled vaccine," Todd said.

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