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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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