ATLANTA (AP/WANE) - Hundreds of thousands of swine flu shots for children have beenrecalled because tests indicate the vaccine doses lost somestrength, government health officials said Tuesday.
John Silcox, spokesperson with the Fort Wayne-Allen CountyHealth Department, said 500 doses of the recalled vaccine had beendistributed to private practices in Allen County. Silcox added thatnone of the recalled doses were offered to the public at the CarewMedical Center.
"We're making sure we pulled all of that, we'll no longer usethat, and we'll return it to the manufacturer as they'veindicated," Silcox told NewsChannel 15. "They're just concernedthat the antigen level might not be as high as it should be, whichdetermines if it will produce an adequate immune response."
According to state health officials, Indiana received about10,000 doses of the affected lots, and the Indiana State Departmentof Health is working closely with local health departments andother providers of the H1N1 flu vaccine to locate any unusedvaccine from the affected lots that have been shipped to Indiana,so they can be returned to the manufacturer.
The shots, made by Sanofi Pasteur, were distributed across thecountry last month and most have already been used, according tothe Centers for Disease Control and Prevention .The 800,000 pre-filled syringes that were recalled are for youngchildren, ages 6 months to nearly 3 years.
Dr. Anne Schuchat, a CDC flu expert, stressed that parents don'tneed to do anything or to worry if their child got one — oreven two — of the recalled shots. The vaccine is safe andeffective, she said.
The issue is the vaccine's strength. Tests done before the shotswere shipped showed that the vaccines were strong enough. But testsdone weeks later indicated the strength had fallen slightly belowrequired levels.
Why the potency dropped isn't clear. "That's the $64,000question," said Len Lavenda, a Sanofi Pasteur spokesman.
Young children are supposed to get two doses, spaced about amonth apart. Health officials don't think children need to getvaccinated again, even if they got two doses from the recalledlots, said Schuchat.
Swine flu vaccine has been available since early October, andsince then manufacturers have released about 95 million doses fordistribution in the United States.
The recalled shots were made by Sanofi Pasteur, the vaccinesdivision of France-based Sanofi-Aventis Group. The vaccine alltested fine when it was shipped out earlier this fall. But lastweek, testing of one lot showed that the potency had fallen about12 percent below the government standard, Lavenda said.
The company found three other lots with diminished strength. Itnotified government health officials and did a voluntary recall,asking doctors to return any unused doses. The vaccine has been inhigh demand and the company doesn't expect to see much come back,Lavenda added.
Officials with the Food and Drug Administration, the CDC and thecompany all said they believe the strength of the recalled doses isstill high enough to protect children against the virus. No potencyproblem has been detected in the same vaccine packaged in othertypes of syringes or vials, Lavenda said.
Experts have a theory that the problem is specific to thechildren's pre-filled syringes. For some reason, the antigen— the key vaccine ingredient — may be sticking to thewalls of those syringes, said Dr. Jesse Goodman, the FDA's deputycommissioner for science and public health.
Another manufacturer, Novartis, in February recalled five lotsof seasonal flu vaccine packed in pre-filled syringes under similarcircumstances.
Sanofi Pasteur bills itself as the No. 1 manufacturer of fluvaccines in the world. It makes flu vaccine at sites in France andin Pennsylvania.
Swine flu was first identified in April. During the first sevenmonths of the pandemic, it has sickened about 50 million Americansand killed about 10,000, according to CDC estimates.
The following information was provided by the Indiana StateDepartment of Health:
Local Health Departments in Indiana who received doses of thenon-safety related recalled
lots of the 2009 H1N1 flu vaccine:
Allen County, Bartholomew County, Benton County, Boone County,Cass County, Clark County,Clinton County, Crawford County, De KalbCounty, Dearborn County, Delaware County, Elkhart County, FloydCounty, Gary City, Grant County, Hamilton County, Hancock County,Hendricks County, Henry County, Howard County, Jackson County,Johnson County, Kosciusko County, LaPorte County, Lake County,Lawrence County, Madison County, Marion County, Miami County,Monroe County, Montgomery County, Morgan County, Noble County,Porter County, Putnam County, Rush County, Shelby County, St.Joseph County, Tippecanoe County, Vanderburgh County, Vigo County,Warrick County, & Wayne County.
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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