By Rob Stein and Michael Laris
Wednesday, December 16, 2009; A04
About 800,000 doses of swine flu vaccine for children are being recalled because tests found the strength of the shots had dropped since shipment, officials announced Tuesday.
The recall was being done as a precaution and not because the vaccine poses any safety threat, officials said. Children who already received the vaccine are thought to have gotten full protection, officials said.
Maryland has received 10,300 doses of vaccine from the affected lots. They went to 48 providers, including 25 locations in Montgomery and Prince George's counties. None went to local health departments. Officials do not know yet how many of the doses have been used.
In Virginia, 23,700 doses are subject to the recall. They were distributed to 64 providers statewide. In the Washington region, that includes health departments in Loudoun, Arlington, Fairfax, and Alexandria, and a government-run clinic in Manassas. Among the private providers are Inova Health System, Capital Area Pediatrics, South Riding Pediatrics and ALL Pediatrics of Alexandria.
Health officials in Maryland and Virginia said they are notifying doctors' offices and other vaccine providers of the recall and the guidance from the federal Centers for Disease Control and Prevention.
Frances Phillips, Maryland's deputy secretary for public health, said the affected doses were shipped to Maryland on Nov. 14 and 28.
Some doses sent to the District are also subject to the recall. "We are working with our provider partners to identify the patients that received those doses," said Health Department spokeswoman Dena Iverson.
"This is a non-safety-related recall," said Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. "There are not any implications for parents and the public."
Most of the vaccine, which was distributed nationwide in November, has probably already been used. Although the potency had dropped, the doses were still considered strong enough to provide adequate protection.
"We don't think there's any harm to anyone who has gotten this," Schuchat said. "In fact, we think the vaccine probably would have worked. They probably got good responses."
The affected vaccine was produced by Sanofi Pasteur and included only prefilled syringes containing 0.25 milliliters for children 6 to 35 months old. The syringes did not contain the preservative thimerosal.
The vaccine passed all required tests before it was shipped, but one lot was found to have dropped in potency during follow-up quality-control testing the company routinely performs. That prompted additional testing, which discovered a similar drop in potency in three other lots, officials said.
No similar problems have been found for other lots or formulations, including the nasal spray, single-syringe doses for older children or multi-dose vials for children and adults. The cause of the potency drop is being investigated, Schuchat said.