HANGZHOU, Dec. 17 (Xinhua) -- China's Zhejiang Province orderedan immediate freeze of 2,880 doses of a U.S.-made children's vaccine for fear of contamination on Monday.
Zhejiang Provincial Disease Control and Prevention Center officials said none of the purchased doses in the batch made by drug company Merck had been used and all were frozen in the eastern coastal province.
The New Jersey-based company announced last week that it had initiated a voluntary recall of 11 lots of its Haemophilus influenza type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenza type B/ hepatitis B vaccine, COMVAX.
"Merck is conducting this recall because it can not assure sterility of these specific vaccine lots," the company said in a statement on its website. "The potential contamination of these specific lots was identified as part of the company's standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine."
The affected doses were distributed from April, it said.
China imported 104,930 questionable PEDVAXHIB doses with the batch number J2438, according to a Beijing Morning Post report on Monday.
The State Food and Drug Administration issued an urgent notice on Sunday ordering a stop to the use of doses that were sold to Beijing, Tianjin, Shandong, Zhejiang, Fujian, Guangdong, Hainan and Sichuan.
Health authorities in south China's Guangdong Province have frozen nearly 19,220 doses, while 7,120 others were sold earlier. No cases of adverse reactions to the vaccines have been reported.
In Beijing, 2,580 of the 2,640 doses purchased were frozen.
PEDVAXHIB was indicated for routine vaccination against an invasive disease caused by Haemophilus influenza type B in infantsand children two to 71 months of age.
The most frequently reported adverse reactions were fever, irritability, sleepiness and soreness, redness or inflammation, swelling or hardening of the skin around the injection site.
Children could also emit an unusual high-pitched or prolonged crying and suffer diarrhea, vomiting, infection or inflammation ofthe ears, rash and upper respiratory infection, it said. Enditem
Editor: Yao
Showing posts with label vaccine. Show all posts
Showing posts with label vaccine. Show all posts
Monday, December 17, 2007
U.S.-made children's vaccine recalled
BEIJING, Dec. 17 -- U.S. pharmaceutical firm Merck & Co and its China importer have recalled 104,930 vials of a children's vaccine against meningitis and pneumonia after they were found to be defective, China's top drug watchdog said yesterday.
Hib is a vaccine for under-five children against meningitis, pneumonia and other serious infections.
The vaccines were distributed in eight Chinese municipalities and provinces, including Beijing and Tianjin, and Zhejiang, Fujian, Guangdong, Hainan and Sichuan, said a statement on the State Food and Drug Administration's website (SFDA). But there have been no reports from any of these places of a child falling ill after vaccination.
In fact, Merck has recalled 1.2 million vials of Hib across the world after finding sterilization defects in the lot made at its Pennsylvania factory on Wednesday.
"The SFDA received the recall report from Merck, and immediate action was taken to track down and help recall the products in China," SFDA spokeswoman Yan Jiangying said.
"Medical institutions in all of the eight places have stopped administering the vaccine, and the existing stock has been sealed."
Guangdong Province had bought 26,340 of the vials, 7,120 of which have already been administered to children, the Southern Metropolis Daily said. And 60 of the 2,640 vials distributed in Beijing have been injected, according to Xinhua.
"All provincial disease control centers have issued urgent notices to order the immediate recall of the vaccines," Yan said.
Medical experts have advised parents who had already been administered Hib not to panic because all imported drugs undergo strict tests before entering the country, and would have been banned in the first place had they been found to be harmful.
(Source: China Daily)
Hib is a vaccine for under-five children against meningitis, pneumonia and other serious infections.
The vaccines were distributed in eight Chinese municipalities and provinces, including Beijing and Tianjin, and Zhejiang, Fujian, Guangdong, Hainan and Sichuan, said a statement on the State Food and Drug Administration's website (SFDA). But there have been no reports from any of these places of a child falling ill after vaccination.
In fact, Merck has recalled 1.2 million vials of Hib across the world after finding sterilization defects in the lot made at its Pennsylvania factory on Wednesday.
"The SFDA received the recall report from Merck, and immediate action was taken to track down and help recall the products in China," SFDA spokeswoman Yan Jiangying said.
"Medical institutions in all of the eight places have stopped administering the vaccine, and the existing stock has been sealed."
Guangdong Province had bought 26,340 of the vials, 7,120 of which have already been administered to children, the Southern Metropolis Daily said. And 60 of the 2,640 vials distributed in Beijing have been injected, according to Xinhua.
"All provincial disease control centers have issued urgent notices to order the immediate recall of the vaccines," Yan said.
Medical experts have advised parents who had already been administered Hib not to panic because all imported drugs undergo strict tests before entering the country, and would have been banned in the first place had they been found to be harmful.
(Source: China Daily)
China's Zhejiang Province freezes suspect doses of children's vaccine
HANGZHOU, Dec. 17 (Xinhua) -- China's Zhejiang Province orderedan immediate freeze of 2,880 doses of a U.S.-made children's vaccine for fear of contamination on Monday.
Zhejiang Provincial Disease Control and Prevention Center officials said none of the purchased doses in the batch made by drug company Merck had been used and all were frozen in the eastern coastal province.
The New Jersey-based company announced last week that it had initiated a voluntary recall of 11 lots of its Haemophilus influenza type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenza type B/ hepatitis B vaccine, COMVAX.
"Merck is conducting this recall because it can not assure sterility of these specific vaccine lots," the company said in a statement on its website. "The potential contamination of these specific lots was identified as part of the company's standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine."
The affected doses were distributed from April, it said.
China imported 104,930 questionable PEDVAXHIB doses with the batch number J2438, according to a Beijing Morning Post report on Monday.
The State Food and Drug Administration issued an urgent notice on Sunday ordering a stop to the use of doses that were sold to Beijing, Tianjin, Shandong, Zhejiang, Fujian, Guangdong, Hainan and Sichuan.
Health authorities in south China's Guangdong Province have frozen nearly 19,220 doses, while 7,120 others were sold earlier. No cases of adverse reactions to the vaccines have been reported.
In Beijing, 2,580 of the 2,640 doses purchased were frozen.
PEDVAXHIB was indicated for routine vaccination against an invasive disease caused by Haemophilus influenza type B in infantsand children two to 71 months of age.
The most frequently reported adverse reactions were fever, irritability, sleepiness and soreness, redness or inflammation, swelling or hardening of the skin around the injection site.
Children could also emit an unusual high-pitched or prolonged crying and suffer diarrhea, vomiting, infection or inflammation ofthe ears, rash and upper respiratory infection, it said. Enditem
Zhejiang Provincial Disease Control and Prevention Center officials said none of the purchased doses in the batch made by drug company Merck had been used and all were frozen in the eastern coastal province.
The New Jersey-based company announced last week that it had initiated a voluntary recall of 11 lots of its Haemophilus influenza type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenza type B/ hepatitis B vaccine, COMVAX.
"Merck is conducting this recall because it can not assure sterility of these specific vaccine lots," the company said in a statement on its website. "The potential contamination of these specific lots was identified as part of the company's standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine."
The affected doses were distributed from April, it said.
China imported 104,930 questionable PEDVAXHIB doses with the batch number J2438, according to a Beijing Morning Post report on Monday.
The State Food and Drug Administration issued an urgent notice on Sunday ordering a stop to the use of doses that were sold to Beijing, Tianjin, Shandong, Zhejiang, Fujian, Guangdong, Hainan and Sichuan.
Health authorities in south China's Guangdong Province have frozen nearly 19,220 doses, while 7,120 others were sold earlier. No cases of adverse reactions to the vaccines have been reported.
In Beijing, 2,580 of the 2,640 doses purchased were frozen.
PEDVAXHIB was indicated for routine vaccination against an invasive disease caused by Haemophilus influenza type B in infantsand children two to 71 months of age.
The most frequently reported adverse reactions were fever, irritability, sleepiness and soreness, redness or inflammation, swelling or hardening of the skin around the injection site.
Children could also emit an unusual high-pitched or prolonged crying and suffer diarrhea, vomiting, infection or inflammation ofthe ears, rash and upper respiratory infection, it said. Enditem
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