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Vaccine cleared in east China infant death: SFDA

(Xinhua)
Updated: 2008-11-06 20:03

BEIJING  -- China's drug safety authority on Thursday cleared a pneumonia and meningitis vaccine of causing the death of a 4-month-old baby last month.

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The baby was vaccinated against Haemophilus influenza type B, or Hib, on October 19 at the Chinese Medicine Hospital in Liaocheng City, Shandong Province, and died the next day.

"This was an occasional clinical case," Yan Jiangying, spokeswoman of the State Food and Drug Administration (SFDA), said at a press conference.

The vaccine was produced by Wosen Biotechnology Co. Ltd. in Yuxi City of the southwestern Yunnan Province.

The government sent an expert team to Shandong to investigate the death and the Yunnan drug safety bureau inspected the company's production plant.

"They found nothing abnormal," Yan said.

Analysis and investigations in many countries had shown occasional adverse reactions to vaccines, such as swelling or allergies, she said.

"More than 90 percent of these adverse reactions have nothing to do with the quality of the vaccines," she said. "It might be due to individual differences."

The Shandong drug bureau has lifted its suspension of the vaccine's distribution and use, imposed shortly after the death.

According to the World Health Organization (WHO) website, Hib is a bacteria that causes meningitis or pneumonia. It is estimated to be responsible for 3 million serious illnesses and about 386,000 deaths per year. Almost all victims are children under the age of five.

The WHO recommends the Hib vaccine as for regular immunization.