Merck’s PedvaxHib Vaccine Recalled in China

By Anna Boyd
11:51, December 16th 2007
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Merck’s PedvaxHib Vaccine Recalled in China

Almost a tenth of 1.2 million doses of PedvaxHib vaccine, which the American drug maker Merck & Co Inc recalled on Wednesday, were sold in China according to local media sources on Friday.

Hib vaccine, which is designed to protect children against meningitis, pneumonia and other diseases caused by the bacterium Haemophilus influezae type B, is administered to children in three doses, at the age of 2 months, 4 months and 12 months. The company said it recalled 11 lots of PedvaxHIB vaccine and 2 lots of its Comvax vaccine because there was no assurance regarding the sterility of the product.

Both vaccines were manufactured in West Point, Pennsylvania and distributed starting with April 2007. Except one lot, which was sold in China, all vaccines were distributed in the United States, the company said.

"The provincial disease control centre has issued an urgent notice ordering the immediate freeze of the vaccines," said the Southern Metropolis Daily, a Chinese newspaper.

The Hib Vaccine was recalled in the United States on Wednesday when Dr. Norman Baylor director of the U.S. Food and Drug Administration’s Office of Vaccine Research and Review said during a teleconference that Merck had identified a bacteria in the equipment used to make the vaccine at one of its locations in West Point, Pennsylvania.

"Merck identified an issue that creates the potential for microorganisms to survive a sterilization step performed during manufacturing. No documented contamination of the vaccine has been found," Baylor said.

Federal health official said children who have already received the vaccine are not at risk and they won’t need to take another vaccine. Children who have not received the vaccine will have to wait until doctors will get another supply. Parents were assured that their children’s health would not be threatened by the delay.

"This is not a health threatening situation right now for children, but it is an inconvenience" for doctors and parents. We'll try to do everything we can to try to restore access," said Dr. Julie Gerberding, director of the U.S. Centers for Disease Control and Prevention.

Health officials urged the other provider of the vaccine, Sanofi Pasteur to boost supplies in a bid to fill the gap caused by the recall.

About 14 million Hib doses are needed annually to vaccinate children according to the CDC



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Tags: China, Merck
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