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China denies baby deaths caused by suspect hepatitis B vaccine

Bloomberg

China has found that a hepatitis B vaccine produced by a Shenzhen biotechnology company didn’t cause the deaths of nine babies who received injections, the national food and drug agency said.

The vaccine for the liver disease made by Shenzhen Kangtai Biological Products Co. was not responsible for the deaths, the China Food and Drug Administration said on a statement on its website.

At least a dozen newborn babies have died nationwide after receiving hepatitis B shots, fueling concern about the safety of vaccines in China, the official Xinhua News Agency reported Tuesday. The Chinese government has been investigating links between the deaths and hepatitis B vaccines that were given as part of a national campaign to immunize against the liver condition.

Three Chinese drug producers, including Kangtai, that make about 80 percent of the nation’s hepatitis B vaccines halted output because they don’t meet new production-quality requirements, Xinhua reported Thursday. The CFDA didn’t find any quality or production problems in a check of two batches of hepatitis B vaccine produced by Kangtai that were under investigation, according to the statement. The agency didn’t say what had caused the baby deaths.

Beijing Tiantan Biological Products Co. and Dalian Hissen Bio-Pharm were among the companies that stopped production Jan. 1, according to Xinhua.

In a statement, Tiantan said it halted operations because it needs to move equipment in order to meet Chinese manufacturing requirements, not because of the investigation into the hepatitis B vaccinations. The company had disclosed the production halt in October.

Xinhua said China has an inventory of more than 25 million batches of hepatitis B vaccine that meet standards aside from the Kangtai products.

Chinese regulators have been pushing to boost consumer confidence in food and drug safety after cases of tainted baby formula, fox meat sold as mutton and thousands of dead pigs found floating in Shanghai’s main river sparked public outrage. Authorities in March elevated the China Food and Drug Administration to a ministry-level agency to strengthen supervision.

Wal-Mart Stores Inc. said Thursday it’s adding DNA tests of meat it sells in China after recalling donkey products from a local supplier that authorities said contained fox DNA.

China’s food and drug regulator Dec. 20 suspended the use of all batches of a hepatitis B vaccine made by Kangtai pending the results of a probe into its connection with the death of four infants. It had on Dec. 13 halted use of two batches of the vaccine.

The three companies accounted for about 80 percent of China’s hepatitis B vaccine output in January through November last year, Xinhua Weibo reported. The vaccinations were added to China’s national immunization program in 2002 and have been free for all children since 2005, according to the Atlanta-based Centers for Disease Control and Prevention.