Georgia received more than 43,000 doses of pediatric swine flu vaccine that have been recalled because they have lost some of their potency, state health officials said Tuesday.
Federal health officials emphasized that the recall is not based on safety concerns, but rather the loss in potency of the pre-filled syringes for infants ages 6 to 35 months.
Some 800,000 doses of the vaccine produced by the pharmaceutical company Sanofi Pasteur have been recalled in the United States.
"There are no safety concerns with these lots," said the Centers for Disease Control and Prevention.
Joye Burton, a spokesman for the Georgia Department of Community Health, said 115 providers received 43,630 doses via direct shipment. Those providers are being contacted by phone.
Len Lavenda, a spokesman for Sanofi Pasteur, said the doses had lost about 12 percent of their potency. Children who received one of the recalled doses do not need to receive a substitute shot, officials said.
Children within that age group were already supposed to receive two shots. If both shots have already been given, the children should be adequately protected against the virus, officials said.
Beyond that, parents of children who received the recalled vaccine do not need to take any other medical action, health officials said.
"In reality, parents should continue doing what they planned to do," Lavenda said. "We think the vaccine is safe. ... There is nothing to be worried about."
Health officials in Fulton, Gwinnett and Clayton said they had not distributed any of the recalled doses at their county-operated health clinics. But officials said they could not speak for the doctors, drugstores and other private health providers in their counties.
At least one Georgia health district had received the recalled doses.
Dave Palmer, a spokesman for District 2 Public Health, which covers 13 counties in North Georgia, said that initial shipments went to private providers.
Those providers, he said, received more than they needed and gave the rest to public health departments.
"We've asked everyone to hold on to the vaccine and then return it when asked to do so," Palmer said.
Lavenda, the company spokesman, said the vaccine had gone through rigorous testing along the way for such things as safety and potency.
The vaccine lots passed all quality controls and met all specifications required by the government agencies at the time of shipping, said a statement by Sanofi Pasteur. The vaccine was first shipped on Sept. 29. Later testing showed a drop in potency.
On Dec. 7, Sanofi Pasteur notified federal health officials that the potency in one batch of pediatric syringes was found to have dropped below the specified limit, according to the CDC.
As a result of this finding, Sanofi Pasteur tested additional lots and found that three other batches measured below the limits.
Sanofi Pasteur is asking that all unused doses be returned.
Unlike the seasonal flu, swine flu has hit young people hard. Young people, their caregivers, people with other health issues and pregnant women are among the target groups urged by the CDC to get the vaccine as soon as it is available.
Dr. Margaret Lewin, a vaccine specialist and medical director for Cinergy Health, said vaccine recalls are rare.
"I really would not panic," she said. "They're not talking about things that affect the safety of the vaccine. They're talking about a slight decrease in potency. The fact that they found something on routine screening makes me very comfortable that they are really monitoring this closely. I'm actually reassured by it."
Q. Is the recalled swine flu vaccine safe?
A. Yes, federal health officials say. These recalled doses passed tests for safety but have lost a bit of their potency since leaving the manufacturer.
Q. What do I do now?
A. There is no need to readminister a dose to those who have received the vaccine. However, all children less than 10 years old should get two doses of swine flu vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose.
Beyond that, parents of children who received vaccine from the recalled lots do not need to take any action.
About the Author
Keep Reading
The Latest
Featured