Wednesday, December 16, 2009

Silicon Valley officials: Flu vaccine given to kids was safe despite recall

Federal health officials Tuesday recalled 800,000 doses of an H1N1 vaccine geared for young children, affecting 900 doses used by Santa Clara County, and an unknown number used by other valley health care providers such as Kaiser Permanente.

The recall is for the shots used for children ages 6 months to 3 years old, made by Sanofi Pasteur, which did a quality control test and found some of the vaccine doses weren't strong enough.

Santa Clara County used those particular doses at free clinics held at the county fairgrounds Dec. 6 and 12, and at the California Children's Services clinic on Empey Way in San Jose. Kaiser also received some of the recalled doses.

Santa Clara County's top health officer says the recall is nothing to be worried about and children don't need to be revaccinated.

"What we're hearing is that the doses are just short of the potency they need to be," Dr. Marty Fenstersheib said. "The children in this age group need to second-dose anyway."

Kaiser spokesman Karl Sonkin said the health care company on Tuesday was still compiling the exact number of recalled doses it received and which facilities received them. He agreed with Fenstersheib that children who received the recalled batch do not need to be revaccinated.

As of Friday, 435,270 doses of H1N1 vaccine for all age groups have been sent to health care providers in Santa Clara County since October, according to state data. As of Dec. 9, 825 people countywide have been hospitalized for serious complications related to H1N1, and 15 have died since May 1. That's 40 more hospitalizations and one more death than in the previous week, according to the county.

Although the antigen level in the recalled batch of vaccines fell slightly short of what's necessary, Fenstersheib pointed to the joint statement by the Food and Drug Administration and the Centers for Disease and Control and Prevention saying the "small decrease in antigen content is unlikely to result in a significant reduction in immune response."

Fenstersheib said that if children received a recalled dose and it was their first swine flu vaccine, they should still get a second dose in about a month, as recommended previously. If the recalled dose was their second vaccination, then he said that would be sufficient. He said children do not need a third vaccine, even if they received one of the less-potent doses.

"The CDC is a conservative agency," he said, "and they tend to err on the side of safety. I'm confident that if they tell us it's potent enough, then it is."

Fenstersheib said the recall is geared mostly for health care providers to send back any of the unused, less-potent batches. He said the shots are perfectly safe and parents shouldn't worry that their children's health has been harmed.

The county receives vaccines from the federal government, and about 90 percent of the H1N1 doses are made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group.

The company reported the potency findings to the government officials and did a voluntary recall. A Sanofi Pasteur representative could not immediately be reached for comment Tuesday.

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.

The Santa Clara County Public Health Department has held five large-scale vaccination clinics so far, including Saturday and Sunday, where more than 8,100 people were vaccinated.

County health officials have used a telephone alert system to remind parents to get their children dosed twice. But Fenstersheib said that as of Tuesday, the health department hadn't notified parents of the recall, although he added his team would discuss doing that.

If anyone has questions, the county has a recorded line answering basic questions about H1N1 at 408-885-3980. Information also can be found at



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