Merck Recalls 1.2 Million Doses Of Children's Shots – PedvaxHIB & Comvax

PedvaxHIB and Comvax VaccinesBeijing: The Chinese media reported on Friday that the U.S. pharmaceutical giant, Merck & Co Inc on Wednesday recalled nearly a tenth of 1.2 million doses of children's vaccines, which were being sold in China.

Merck’s action of voluntary recall of 11 lots of PedvaxHIB vaccine and two lots of its Comvax vaccine came after quality-control checks found production equipment might not have been properly sterilized. During a routine inspection of their manufacturing process, Merck officials found that some equipment was contaminated with bacteria called Bacillus cereus. The vaccines were manufactured in West Point, Pennsylvania, and distributed in April 2007.

According to the Southern Metropolis Daily, the company told that the only lot which had been distributed outside the United States had been exported to China. More than 10,000 of the 104,930 doses sold across China were bought by the southern province of Guangdong.

The newspaper said, “The provincial disease control centre has issued an urgent notice ordering the immediate freeze of the vaccines.”

According to the newspaper, Health authorities in Guangdong had received no reports of adverse reactions to the vaccines, however, and experts had advised parents not to panic as imported drugs had to undergo strict tests entering the country.

On the other hand, China has accused Western media of sensationalism reporting of a wave of scandals this year over its exports of food, drugs and other products, saying it also suffers from substandard goods imported from developed nations but does not hype up the problems.

According to the U.S. Centers for Disease Control and Prevention, the recalled vaccines have been widely used against Hib disease (Haemophilus influenzae type b), which used to be the leading cause of bacterial meningitis in children under 5. The vaccines are highly effective against meningitis, pneumonia and other infections.

Doctors feel that the recall of children's vaccine could delay booster shots and cause shortage of shortage of children's vaccines.

Dr. Chris Nerwen of Schneider Children's Hospital on Long Island, said, "There will not be a problem for children to get the vaccine in this country.”

Merck manufactures about half of the country's 14 million-vial supply of Hib vaccine, which is given to babies at 2-, 4- and 12-15 months. The Centers for Disease Control and Prevention has a stockpile of 750,000 doses, and officials asked drugmaker Sanofi Pasteur to ramp up its production.
According to the CDC officials, they did not expect the shortage to cause public health problems. Since Hib was introduced in 1985, the number of yearly illnesses has plummeted from about 20,000 a year to fewer than 200.
However, officials have not received reports of children reacting adversely to the recalled batch of vaccine, which was distributed in April. It's unknown how many doses were dispensed.
The American Academy of Pediatrics has said that doctors affected by the recall can defer the 12-to-15-month booster in healthy children.

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