Investigators test vaccines linked to 6 babies' deaths

2013-12-25 01:43:41 GMT2013-12-25 09:43:41(Beijing Time)  Shanghai Daily

China has sent investigators into the nation’s biggest hepatitis B vaccine producer after its products were linked to at least six deaths of infants nationwide in the past few weeks.

One more death is linked with another vaccine producer in Beijing.

The team is checking production and testing vaccines at Shenzhen-based Biokangtai and results should be known in about 20 days, the state drugs and health agencies announced yesterday.

More than 44 million hepatitis B vaccines in 198 batches from Biokangtai had been sent to 27 provincial areas, the China Food and Drug Administration and the National Health and Family Planning Commission said, without identifying the places apart from saying that more than 6.6 million were sold in Guangdong Province, where three babies died after being injected, and 3 million in Hunan Province, where two babies had died.

All the vaccines have been placed under official control, officials told a press conference.

Shanghai health authorities said the city was not one of Biokangtai’s customers. All its hepatitis B vaccines come from a company based in Dalian, a city in the northeastern Liaoning Province. The company wasn’t named. The Shanghai Food and Drug Administration inspects samples every year, in addition to a state test, to ensure safety, the city’s publicity department said yesterday.

Last Friday, the state drugs and health agencies issued a circular banning the use of Biokangtai vaccines. The ban wouldn’t cause a shortage, authorities said, as qualified vaccines from five other domestic companies are sufficient to treat 25 million babies.

China’s medical rules state that infants should get a free hepatitis B vaccine within 24 hours of birth. About 50,000 Chinese are born each day, according to official estimates, and most are vaccinated.

Biokangtai, established in 1988, had about 60 percent share of the market and sales of 10 million vaccines a year in China, according to The Time Weekly.

On Monday, the Disease Control and Prevention Center in Beijing said it only used hepatitis B vaccines produced by a Dalian company and Beijing Tiantan Biological Products Co Ltd, China News Service reported.

However, Tiantan is involved in one case where a baby died.

A newborn in China’s southwestern Sichuan Province died on Monday morning, 10 hours after an injection of Tiantan’s hepatitis B vaccine, bringing the total of China’s suspected vaccine-related deaths to seven.

The six other infants received vaccines made by Biokangtai — three died in Guangdong, two in Hunan and one in Sichuan, health authorities said.

The Guangdong Disease Control and Prevention Center confirmed that a previously suspected case was not related to the vaccine. The baby in that case died of pneumonia, the center said.

Autopsy results have yet to be released for the seven cases.

Last Tuesday, Biokangtai said the deaths had nothing to do with its vaccines. The vaccines had not expired and there were no problems during production, storage or transportation, it said. “The coincidental events are commonplace and easy to misinterpret,” a company statement said.

However, a senior government expert on diseases said that while the vaccine-related deaths could be due to coincidence, Biokangtai was not in a position to make an objective assessment.

“We should not treat the company’s statement like a conclusion,” Dr Zeng Guang, chief epidemiologist with the China Center for Disease Control and Prevention, told The Associated Press. “They may be trying to protect their self-interest. Or they may have a lot of confidence in their product.”

Tiantan has made no comment on the latest Sichuan case.

Zeng urged the public not to panic, saying that in general Chinese vaccines were safe and that more people would die if everyone refused inoculations.

“If the public refuses to be vaccinated, or if they try to change the vaccination procedures, the consequence will be extremely bad,” Zeng said. “Instead of several deaths, it will cause tens of thousands of deaths.”

Officials from the disease control center said it had received reports of 188 deaths following hepatitis B vaccinations between 2000 and last Friday, according to news portal www.163.com. None of those deaths, not including the recent cases still to be determined, was due to problems with vaccines, they said.

Hepatitis B is a chronic liver infection that is spread through the blood or bodily fluids of infected people. It can cause liver inflammation and jaundice.

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