Some swine flu vaccine recalled in N.C.
Posted December 15, 2009 11:04 a.m. EST
Updated December 16, 2009 1:37 a.m. EST
ATLANTA — Hundreds of thousands of swine flu shots for children have been recalled because tests indicate the vaccine doses lost some strength, government health officials said Tuesday.
The recall is for about 800,000 pre-filled syringes intended for young children, ages 6 months to nearly 3 years. 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.
Doctors were notified of the voluntary recall on Tuesday. Dr. Anne Schuchat, a CDC flu expert, stressed that parents don’t need to do anything or to worry. The vaccine is still safe, she said.
Almost 18,000 doses of the recalled vaccine were distributed in North Carolina, said Amy Caruso, spokeswoman for the Immunization Branch of the state Department of Health and Human Services. Officials were contacting 132 health care providers statewide who received the vaccine from the batches being recalled, she said.
None of the vaccine administered at Wake County-sponsored immunization clinics was part of the recall, county spokeswoman Sarah Williamson said. Six private physician practices in the county did receive the recalled Sanofi Pasteur pre-filled syringes, however.
"All of these children already need to receive two vaccinations to get the full series, and as long as they get the two vaccinations, they should be fine. They don't need any additional vaccination, and they're perfectly safe," State Epidemiologist Megan Davies said. "This vaccine is a safe vaccine. It's just not strong enough."
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.
Children in that age group are supposed to get two doses, spaced about a month apart. Health officials don’t think children need to get vaccinated again, even if they got two doses from the same lots, said Schuchat.
North Carolina has received sufficient vaccine to meet the needs of the affected age group, as well as the general population, officials said, encouraging people to get immunized against H1N1.
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 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.