Nearly 150,000 swine flu vaccines for Texas kids recalled

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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.

http://www.chron.com/disp/story.mpl/headline/metro/6771936.html

 

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Re: Nearly 150,000 swine flu vaccines for Texas kids recalled

Swine flu vaccine for kids recalled over effectiveness


[SIZE=-1]Wednesday, December 16, 2009[/SIZE][SIZE=-1]By JEFFREY WEISS / [/SIZE][SIZE=-1]The Dallas Morning News [/SIZE]
[SIZE=-1]jweiss@dallasnews.com [/SIZE]




A national recall of H1N1 flu vaccine is more worrisome for its potential effect on people not yet vaccinated than for the children who got the shots, Texas health officials said Tuesday.

The Centers for Disease Control and Prevention announced that 800,000 doses of swine flu vaccine had been recalled because tests showed they had lost strength faster than expected. The vaccine was designed for children 6 months to 35 months old.

"It is not an issue of safety," said Dallas County heath department director Zachary Thompson. "It's a question of effectiveness."

The vaccine was distributed last month and most of it has already been used, the CDC said. Children who got it do not need additional vaccine beyond the two doses previously recommended for all children younger than 10 years old.

"Parents do not need to do anything," said Carrie Williams, spokeswoman for the Texas health department.

The recall order was issued as Texas public health officials are trying to convince many reluctant people that they still need to get the vaccine, even though the swine flu itself has all but vanished in much of the state.

"It raised the question of why they should even get the vaccine," Thompson said. "This doesn't help us."

Health officials say they are still concerned that this virus will repeat the patterns set by previous flu pandemics and return early next year. But a poll released Tuesday by the University of North Texas Survey Research Center shows that many North Texans are tuning out the drumbeat of expert advice.

Only 39 percent of people in Dallas, Tarrant and Denton counties questioned between Oct. 30 and Nov. 18 said they received or plan to get the H1N1 vaccine. That compares with 63 percent who said that they received or planned to get a seasonal flu shot.

Small percentage


The recalled vaccine was in four lots manufactured by Sanofi Pasteur and represents less than 1 percent of more than 84 million H1N1 doses distributed in the United States. Texas officials said that 1,650 medical providers in Texas received some of the recalled lots.

None of the doses were included in shipments to the Dallas County health department. But 600 doses of the vaccine considered surplus by one Dallas County doctors' office were given to the health department, which sent 350 doses two other local doctors, according to the Dallas health department.

Those doctors ? along with others across the nation ? are being advised not to use vaccine from those lots.

"This shows us is that even when an FDA-approved product is released onto the market, there are still ongoing tests of quality," said Dr. John Carlo, Dallas County's medical director. "That's a plus."
How can a flu shot lose its strength? In some ways, a vial of vaccine is like a carton of milk: It lasts only so long before going bad.

In the case of this vaccine, "going bad" means a slow breakdown in the tiny bits of protein that prod the body into defending itself against the flu. If there aren't enough of those bits, called antigen, the vaccine won't provoke a strong enough immune response.

The vaccine was strong enough when it was tested in the factory but failed subsequent tests, the CDC said. Federal officials said they did not know why those particular doses, and only those doses, dropped so much in strength.

"The antigen content in the affected lots of vaccine is only slightly below the specification limit," the CDC said in a news release. "The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response."

Shots urged


Medical effectiveness aside, that still leaves public health officials with the challenge of overcoming the effect of bad publicity on people already not inclined to get the vaccine.

But the decision should not be that difficult, said Dr. Jeffrey Kahn, chief of infectious diseases at Children's Medical Center Dallas and professor of pediatrics and microbiology at UT Southwestern.

On the one hand, the CDC estimates that more than 10,000 people have been killed by the H1N1 flu, he said. On the other hand, there have been no reported deaths or serious effects linked to the vaccine.

"If you compare the disease to the vaccine, I would prefer to get vaccinated," he said. "This vaccine is potentially protecting you from a life-threatening illness. It's protecting people around you from a potentially life-threatening illness."

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