H1N1 Pediatric Vaccine Recalled for Low Potency, Not Safety

By Samantha L. Quigley
American Forces Press Service

Dec. 17, 2009 - Some supplies of a pediatric version of the H1N1 vaccine have been voluntarily recalled because they are slightly less potent than the manufacturer indicated, officials said today. Some pre-filled syringes [of the vaccine] for infants from 6 months to 35 months of age were recalled because the antigen content was slightly lower upon distribution than when it was created, Army Lt. Col. Patrick Garman, directory of the military vaccine agency, said.

"So it's slightly less than what the manufacturer is saying," Garman added. "It's a non-safety issue. It's a potency issue, or a strength issue."

Antigen is the active ingredient in the vaccine that stimulates an immune response and results in protection against influenza.

The drop in effectiveness is so small that the effected vaccines that have been distributed still will provide an adequate immune response, Garman said.

While revaccination isn't necessary, it's important to understand that anyone under the age of 10 requires two doses of the vaccine to be fully immunized, he added.

"These individuals that were given the pre-filled syringe ... they don't need a third vaccination," Garman said. "That first one counts and after a month goes by they should still come back in and get their second dose."

About 800,000 doses distributed throughout the United States were recalled. Some of those doses were distributed to military treatment facilities and given to military children.

They are as protected against H1N1 as any other child who has received only one of the two doses required, Garman said.

There are other multi-dose products available for the younger population, he added. One, another injectable, is good for those aged 6 months to adult. The younger patients still would receive the vaccine in two .25 milliliter doses, but adults would receive only one .5 milliliter dose.

"Another product is the intranasal product, which some parents really like," Garman said. "You ... spray it up your two-year-old's nose and they're protected."

It's approved for those from 2 to 49 years.

"What we were able to check rather quickly on the [recalled supply] was the stuff that was going to the uniform personnel, because that comes directly to us," Bryan G. Whitman, deputy assistant secretary of Defense for Public Affairs.

Military facilities in the states receive their vaccinations from the state in which they are located. They are inspecting their supply to determine whether they received any of the recalled vaccine, Whitman added.

Sanofi Pasteur Inc. is the manufacturer of the recalled supplies and initiated the testing of and voluntary recall of the prefilled syringes.