800,000 doses of H1N1 vaccine recalled

ATLANTA (AP/WANE) - Hundreds of thousands of swine flu shots for children have been recalled because tests indicate the vaccine doses lost some strength, government health officials said Tuesday.

John Silcox, spokesperson with the Fort Wayne-Allen County Health Department, said 500 doses of the recalled vaccine had been distributed to private practices in Allen County. Silcox added that none of the recalled doses were offered to the public at the Carew Medical Center.

"We're making sure we pulled all of that, we'll no longer use that, and we'll return it to the manufacturer as they've indicated," Silcox told NewsChannel 15. "They're just concerned that the antigen level might not be as high as it should be, which determines if it will produce an adequate immune response."

According to state health officials, Indiana received about 10,000 doses of the affected lots, and the Indiana State Department of Health is working closely with local health departments and other providers of the H1N1 flu vaccine to locate any unused vaccine 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 the country last month and most have already been used, according to the Centers for Disease Control and Prevention . The 800,000 pre-filled syringes that were recalled are for young children, ages 6 months to nearly 3 years.

Dr. Anne Schuchat, a CDC flu expert, stressed that parents don't need to do anything or to worry if their child got one — or even two — of the recalled shots. The vaccine is safe and effective, she said.

The issue is the vaccine's strength. Tests done before the shots were shipped showed that the vaccines were strong enough. But tests done weeks later indicated the strength had fallen slightly below required levels.

Why the potency dropped isn't clear. "That's the $64,000 question," said Len Lavenda, a Sanofi Pasteur spokesman.

Young children are supposed to get two doses, spaced about a month apart. Health officials don't think children need to get vaccinated again, even if they got two doses from the recalled lots, said Schuchat.

Swine flu vaccine has been available since early October, and since then manufacturers have released about 95 million doses for distribution in the United States.

The recalled shots were made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group. The vaccine all tested fine when it was shipped out earlier this fall. But last week, testing of one lot showed that the potency had fallen about 12 percent below the government standard, Lavenda said.

The company found three other lots with diminished strength. It notified government health officials and did a voluntary recall, asking doctors to return any unused doses. The vaccine has been in high demand and the company doesn't expect to see much come back, Lavenda added.

Officials with the Food and Drug Administration, the CDC and the company all said they believe the strength of the recalled doses is still high enough to protect children against the virus. No potency problem has been detected in the same vaccine packaged in other types of syringes or vials, Lavenda said.

Experts have a theory that the problem is specific to the children's pre-filled syringes. For some reason, the antigen — the key vaccine ingredient — may be sticking to the walls of those syringes, said Dr. Jesse Goodman, the FDA's deputy commissioner for science and public health.

Another manufacturer, Novartis, in February recalled five lots of seasonal flu vaccine packed in pre-filled syringes under similar circumstances.

Sanofi Pasteur bills itself as the No. 1 manufacturer of flu vaccines in the world. It makes flu vaccine at sites in France and in Pennsylvania.

Swine flu was first identified in April. During the first seven months of the pandemic, it has sickened about 50 million Americans and killed about 10,000, according to CDC estimates.

The following information was provided by the Indiana State Department of Health:

Local Health Departments in Indiana who received doses of the non-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 Kalb County, Dearborn County, Delaware County, Elkhart County, Floyd County, 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.