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Some H1N1 vaccine recalled

Potency, not safety at issue

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POSTED: December 18, 2009 9:30 a.m.

Some doses of the H1N1 vaccine that have been voluntarily recalled were administered to area children by local health departments.
The Coastal Health District, which includes Liberty and Bryan counties, received 100 doses of the recalled vaccine.  About 45 doses from this recalled lot were administered across the district.
Vaccine manufacturer Sanofi Pasteur recalled its doses of H1N1 vaccine that came in pre-filled pediatric syringes meant for children ages 6-35 months because they did not meet the required level of potency.

“The vaccine that has been voluntarily recalled is perfectly safe,” said Dr. Diane Weems, chief medical officer for the Coastal Health District. “The potency of the recalled vaccine is only slightly below the specified range and the vaccine in these lots is still expected to be effective.”
According to Weems, the vaccine was recalled because testing by the manufacturer revealed that the antigen content in four lots of the vaccine had lower than required potency levels. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus.
According to the health district, the CDC and FDA agree that because the recalled vaccine is still expected to provoke an immune response to the H1N1 flu, there is no need to revaccinate anyone who has received vaccine from the recalled lots.
“Those children who received these vaccines do not need to be revaccinated,” said Sally Silbermann, Coastal Health District spokesperson.
However, Silbermann said it is standard practice that children younger than 10 receive two vaccinations for H1N1 and two for the seasonal flu, in order to receive full immunity.
“They would get the initial vaccine and then follow up with the booster,” she said. “They would get the vaccines at least 28 days apart.”
Therefore, children younger than 10 years old who have received only one dose of H1N1 vaccine so far should still receive a second dose, health officials said. 
Silbermann said district health departments are sending out letters of notification to parents whose children received the recalled vaccine.
Unused vaccine from the recalled lots will be returned to the manufacturer as requested.

 

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