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Children in many areas of the United States have already been given some of the swine flu vaccines that were recalled Tuesday. But it should pose no danger to them, and they do not need to be revaccinated, according to public health officials.
The recalled vaccine doses were in the form of prefilled syringes meant for children ages 6 months to 3 years.
"We suspect there's no real implication," Dr. Susan Fernyak, director of communicable disease control and prevention at the San Francisco Department of Public Health, told the San Francisco Chronicle. "Most likely children who already received the vaccine are going to have an adequate immune response. We're going to accept they got proper immunity from it."
So why do the recall? Because when the batch was retested, it was found to be losing potency over time. From the Chronicle:
“Sanofi Pasteur, the vaccine division of French pharmaceutical company Sanofi-Aventis Group, voluntarily recalled the vaccine after tests showed the doses had lost some potency. The vaccines initially were strong enough, but when a batch was retested Dec. 7 the doses were found to be below the minimum potency required by the CDC and the Food and Drug Administration. The company then checked other batches and found four lots - for a total of 800,000 doses - had reduced potency.
“But the potency of the recalled doses was only "slightly below" required levels, the CDC said Tuesday.
Young children need two doses of swine flu vaccine, given at least three weeks apart, to be protected. Those who received one dose of the recalled vaccine should get a second dose, and children who received the recalled vaccine as their second dose need not get a third.”
The doses that were recalled are from just one of five manufacturers making the vaccine for the United States. None of the vaccines from other companies have been recalled.
From CNN:
The CDC emphasized that there is no danger for any child who received this type of vaccine.
When asked what parents should do, CDC spokesman Tom Skinner said, "absolutely nothing." He said if children receive this vaccine, they will be fine.
Sanofi Pasteur spokesman Len Lavenda said that the company's test results found the recalled vaccine's potency was 12 percent below the point where it should have been. He added that the company has done studies in the past that showed "vaccine containing as little as half of the recommended dosage" still created the necessary immune response in children.
Lavenda said Sanofi Pasteur has never had this happen with a flu vaccine before, and the company is having all of its experts investigate the cause of this loss in potency.
Here’s the detailed Centers for Disease Control page on this:
http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
The San Francisco Chronicle story:
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/12/15/MNQ81B4OPJ.DTL&tsp=1
From CNN:
http://www.cnn.com/2009/HEALTH/12/15/flu.vaccine.recall/
From ABC News:
http://abcnews.go.com/Health/SwineFluNews/sanofi-pasteur-recalls-800000-doses-h1n1-vaccine/story?id=9347146
Add a Comment1 Comments
Thanks Diane, I was just watching the news on this subject this morning. They basically made a weak batch and it may not be effective in protecting children against h1n1. I'm sure there will still be an uproar because nobody wants to give their child[ren] a vaccine twice. :-/ It's good to know that the recall wasn't based on contamination or anything that could potentially cause harm to those who have received them.
December 16, 2009 - 6:35amThis Comment