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CFDA and WHO say hepatitis B vaccine safe

By Wang Qingyun ( China Daily USA ) Updated: 2014-01-04 07:31:26

Chinese authorities and World Health Organization experts said on Friday they haven't found problems in the hepatitis B vaccine made by drug manufacturer Biokangtai, which had been suspected of causing 17 deaths.

Since December, babies have been reported to have died or had serious adverse reactions after being injected with the hepatitis B vaccine produced by the Shenzhen company.

The China Food and Drug Administration and the National Health and Family Planning Commission issued a notice on Dec 20 to stop using the vaccine produced by the company until an investigation was completed.

According to a circular issued on Friday, from Dec 21 to 27, the CFDA conducted a thorough inspection of the company's manufacturing process and didn't find operations that may adversely affect the vaccine's quality.

Also, the National Institutes for Food and Drug Control, an organization in charge of testing and approving vaccines before they go on the market, found no problems in the batches of Biokangtai's vaccine reportedly involved in the deaths and adverse reactions.

Neither did they find operational problems in the vaccine's storage, transport or injection, said the circular.

Of the 17 deaths that were reported, nine were excluded as having nothing to do with the injection of the vaccine, and the other eight are waiting for the autopsy results, said the circular.

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