South Carolina officials are returning 20,500 swine flu shots because of a recall. Approximately 800,000 pre-filled syringes, all intended for young children six months to three years of age, have been recalled nationally. The manufacturer, Sanofi Pasteur, says the vaccine has lost a little of its strength since it was originally tested.
Department of Health and Environmental Control spokesman Thom Berry says most of the vaccine doses from that batch have already been administered, but that’s not a major problem. “The message we’re getting from the manufacturer and the Centers for Disease Control is that the vaccine is not harmful, it’s just not as strong as it should be,” says Berry.
Young children are supposed to get two doses, spaced about a month apart. Berry says the vaccine does not pose any health risk to the children who took it, even if they receive two doses. “The CDC and the FDA set a minumum standard for the strength of the vaccine,” he says. “The four lots being recalled were just not strong enough.”Sanofi Pasteur claims to be the #1 manufacturer of flu vaccines in the world. It has facilities in France and Pennsylvania.
Berry stresses that parents of young children who have been vaccinated don’t need to do anything. “Children don’t need to be re-vaccinated,” he says. “It apparently is just below that minimum standard, but still produces plenty of positive effect.”
And Berry says no one should be deterred from getting an H1N1 vaccine. “We have plenty of H1N1 vaccines and all of the recalled lots have been sent back to the manufacturer,” he says. “We’re still doing vaccination clinics and will continue doing that through the holidays and on into the new year.”
The vaccine has been available since early October and 95 million doses have been distributed in the U.S.