CFDA and WHO say hepatitis B vaccine safe

National, world health organizations review findings from investigation

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.

Shutdown won't affect nation's supply

There won't be a shortage of supplies in 2014 even though three major hepatitis B vaccine makers in China have halted production, experts said.

Biokangtai, along with two other companies in Beijing and Dalian, stopped making hepatitis B vaccine after failing to get a certification of a revised good manufacturing practice code by Dec 31, as China Food and Drug Administration had asked.

The GMP code applies to all the pharmaceutical manufacturers whose products are sold in China.

Although the three companies' hepatitis B vaccine products account for about 75 percent of the market, the halt in production won't create a shortage, Li Guoqing, a senior official with CFDA, said at a news conference on Friday.

"We assigned the manufacturers different tasks at the same time. Some were storing the vaccine, while others were busy updating their production lines to meet the new GMP standard, to guarantee the supply of vaccine," he said.

"As far as I know, the companies in Dalian and Beijing are now renovating their workshops to meet the new standard, and will apply for the new GMP certification in two to three months," said Zhao Kai, a vaccine expert with the National Vaccine and Serum Institute.

Biokangtai has passed the assessment of the new GMP, and will get a new certification and resume production if no one files a dissent in a certain period of time, Li said.

Beijing Tiantan Biological Products Co said in an online statement on Friday that it halted production of the vaccine on Dec 31 but had stored vaccine to sell in 2014.

It said it expects it will resume production by the second half of the year.

An employee of Hissen, the vaccine company in Dalian, also told China Daily it had been working at full capacity before the new GMP standards took effect to guarantee the supply.

Shen Qi, director of the biological products testing department under the National Institutes for Food and Drug Control, said there is no need to worry as there is plenty of stored vaccine, and the companies will resume "huge" production soon as they get the new certification.

"There will be about 16 million babies born in China in 2014, and we will definitely guarantee the supply of the vaccine," she said.

wangqingyun@chinadaily.com.cn