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CFDA and WHO say hepatitis B vaccine safe

English.news.cn   2014-01-04 09:10:22            

By Wang Qingyun

BEIJING, Jan. 4 (Xinhuanet) -- 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.

Another case of adverse reaction, which was already discharged from the hospital, was possibly caused by shock due to an allergic reaction.

The causes of the 17 deaths vary, including severe pneumonia, suffocation, kidney failure, severe diarrhea and congenital heart disease, added the circular.

Experts from WHO agreed with the CFDA inspection results.

"So far ... the main message is that there is actually no evidence to support that there is an issue with the product that has been distributed and used," Lahouari Belgharbi, a WHO expert in immunization, told China Central Television.

Fabio Scano, head of disease control at WHO's China office, said: "I would like to emphasize that the steps taken in the investigation are in line with the WHO recommendation. And we are happy to have been working together for the last couple of days to review the findings of the joint investigation by CFDA and the commission.

"It's crucial to reassure the public and also parents' confidence in the hepatitis B vaccine program, definitely one of the most successful public programs in China. And it has prevented millions of hepatitis B infections over the last two decades," he added.

Biokangtai and two other large companies have currently stopped production of hepatitis B vaccines, as they didn't pass a new good-manufacturing practice certification imposed by the CFDA by the end of 2013.

This has raised the public's concern over the quality of the company's vaccine.

However, Zhao Kai, a vaccine expert with the National Vaccine and Serum Institute, dismissed the concern.

"The GMP code needs constant revision, as it was also revised in 1998. The vaccine produced before the latest GMP standards took effect have passed official tests before entering the market, and were made according to the older GMP," he said.

(Source: China Daily)

 

Editor: Luan
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