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Preservative-Free Hepatitis B Vaccine 

March 31, 2000. 

 The US Food and Drug Administration has approved a preservative-free hepatitis B vaccine manufactured by SmithKline Beecham. The reformulated Engerix-B will be available within the next few weeks in 10 mcg/0.5ml doses for pediatric and adolescent use.

The availability of this vaccine means that there should now be sufficient quantities of hepatitis B vaccine that do not contain thimerosal as a preservative available for children of all ages.

The new Engerix-B contains only trace amounts of thimerosal (<1 mcg) which "have no clinically relevant effects making it equivalent to a thimerosal-free product", according to IVS director, Dr. Neal Halsey.

Dr. Halsey urges parents to maintain routine immunization schedules in order to protect children from hepatitis B, a serious liver disease that infects more than 100,000 people in the US every year. The use of hepatitis B vaccine also helps prevent liver cancer.

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This page was last updated on August 08, 2012

Institute for Vaccine Safety