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Nearly 150,000 swine flu vaccines for Texas kids recalled
By CINDY GEORGE Copyright 2009 Houston Chronicle
Dec. 15, 2009, 4:50PM
Texas received nearly 150,000 doses of H1N1 vaccine for children that has been recalled because it's not strong enough, said Carrie Williams, a spokeswoman for the Texas Department of State Health Services.
Those doses went to about 1,650 providers across the state and most were shipped in November. State health officials are contacting those providers by e-mail this afternoon asking them not to administer the doses and to set them aside.
?We?ve been working to pinpoint who received what and provide notifications of what to do,? Williams said.
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 nationally are for young children, ages 6 months to nearly 3 years.
It is unclear if or how many of the weakened doses arrived in the Houston area. And, it is possible that many of the vaccines have been administered to children. Large local providers, including the Harris County Hospital District and health departments in Montgomery, Brazoria and Fort Bend counties, said they were not shipped any of the recalled vaccine. The hospital district won?t use 1,800 remaining doses from Sanofi Pasteur until other batches produced there can be tested.
?It is not a safety issue,? Williams said. ?It?s a matter of a slight difference in potency.?
Parents are urged to make sure children under 10 receive two doses of H1N1 vaccine. CDC officials said that even if small children have finished their regimen ? and both doses came from the recalled batches ? that no additional vaccine is recommended.
The state hasn?t received federal guidance about whether to contact parents, but has left that decision to providers.
?It?s really something that wouldn?t change what a parent would need to do or not do,? Williams 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.
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 Associated Press contributed to this story.
By CINDY GEORGE Copyright 2009 Houston Chronicle
Dec. 15, 2009, 4:50PM
Texas received nearly 150,000 doses of H1N1 vaccine for children that has been recalled because it's not strong enough, said Carrie Williams, a spokeswoman for the Texas Department of State Health Services.
Those doses went to about 1,650 providers across the state and most were shipped in November. State health officials are contacting those providers by e-mail this afternoon asking them not to administer the doses and to set them aside.
?We?ve been working to pinpoint who received what and provide notifications of what to do,? Williams said.
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 nationally are for young children, ages 6 months to nearly 3 years.
It is unclear if or how many of the weakened doses arrived in the Houston area. And, it is possible that many of the vaccines have been administered to children. Large local providers, including the Harris County Hospital District and health departments in Montgomery, Brazoria and Fort Bend counties, said they were not shipped any of the recalled vaccine. The hospital district won?t use 1,800 remaining doses from Sanofi Pasteur until other batches produced there can be tested.
?It is not a safety issue,? Williams said. ?It?s a matter of a slight difference in potency.?
Parents are urged to make sure children under 10 receive two doses of H1N1 vaccine. CDC officials said that even if small children have finished their regimen ? and both doses came from the recalled batches ? that no additional vaccine is recommended.
The state hasn?t received federal guidance about whether to contact parents, but has left that decision to providers.
?It?s really something that wouldn?t change what a parent would need to do or not do,? Williams 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.
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 Associated Press contributed to this story.
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