Vac­cine probe

450,000 shots pulled though au­thor­i­ties are yet to con­firm link to ad­verse re­ac­tion

China Daily (Hong Kong) - - FRONT PAGE - BY SHAN JUAN shan­juan@chi­ Hou Liqiang and Li Wenfang con­trib­uted to the story.

Na­tional drug ad­min­is­tra­tion sus­pends use of two batches of hep­ati­tis B vac­cines af­ter two chil­dren died fol­low­ing in­jec­tions.

China’s top drug ad­min­is­tra­tion has sus­pended two batches of hep­ati­tis B vac­cine from use af­ter the sus­pi­cious deaths of two ba­bies last week.

The batches of vac­cine, to­tal­ing about 450,000 shots, have been sus­pended from use pend­ing fur­ther in­ves­ti­ga­tion, al­though of­fi­cials said no clear link be­tween the deaths and the vac­cines has been es­tab­lished.

Two ba­bies, aged 8 months and 1 month, from Changn­ing and Heng­shan in Hu­nan prov­ince died soon af­ter be­ing given the vac­cine. One died one day later, while the other died three days later.

The vac­cine was man­u­fac­tured by the Shen­zhen-based com­pany Biokang­tai. It has been pro­duc­ing the vac­cine since 1994 and now has more than 50 per­cent of the to­tal mar­ket share on the main­land.

The Hu­nan Pro­vin­cial Center for Disease Con­trol and Preven­tion has been con­duct­ing in­ves­ti­ga­tions into the deaths.

Gao Li­dong, deputy di­rec­tor of the center, told China Na­tional Ra­dio that pre­lim­i­nary in­ves­ti­ga­tions have dis­cov­ered no di­rect link be­tween the vac­cines and the ba­bies’ deaths.

“We are ex­plor­ing more fac­tors, such as whether the pro­ce­dures for ad­min­is­ter­ing the vac­cines were prop­erly prac­ticed,” he said.

Gao re­vealed that another 1-month-old boy, from Han­shou in Hu­nan, also be­came ill af­ter be­ing in­jected with the Biokang­tai vac­cine.

The baby was saved by timely in­ter­ven­tion and is now un­der ob­ser­va­tion at a hos­pi­tal, he said.

Mean­while, an of­fi­cial from Hu­nan Food and Drug Ad­min­is­tra­tion who iden­ti­fied her­self by her sur­name Li said on Sun­day that it was still not clear whether the vac­cine had killed the two ba­bies.

“One baby was in­jected not only with vac­cine but also with vitamin K,” Li said.

“They didn’t die di­rectly af­ter be­ing in­jected with the vac­cine. One baby died one day af­ter the in­jec­tion and the other died three days af­ter. There may have been (other) prob­lems in their treat­ment,” she said.

On Fri­day evening, the ad­min­is­tra­tion is­sued an emer­gency no­ti­fi­ca­tion to sus­pend the use of the vac­cine.

“The au­top­sies on the two ba­bies are still un­der­way,” Li said.

“If the re­sults of the au­top­sies show that there is a prob­lem with the qual­ity of the vac­cine, we will re­call all of the vac­cine that has en­tered Hu­nan prov­ince,” she said.

Ac­cord­ing to the Shen­zhen mu­nic­i­pal­ity drug ad­min­is­tra­tion, the in­ci­dent in­volved two batches of vac­cines, to­tal­ing 450,000 doses.

The ad­min­is­tra­tion has con­ducted an on-site in­spec­tion of the com­pany and found no prob­lems in pro­duc­tion, said a state­ment is­sued by the ad­min­is­tra­tion Fri­day.

It also said the vac­cines were found to have been sold to Hu­nan, Guang­dong and Guizhou prov­inces.

In re­sponse, the China Food and Drug Ad­min­is­tra­tion, the na­tion’s top drug au­thor­ity, pub­lished a cir­cu­lar on Fri­day urg­ing lo­cal au­thor­i­ties and disease con­trol cen­ters to sus­pend the use of the two batches.

Ac­cord­ing to the Shen­zhen drug ad­min­is­tra­tion, the com­pany does not have any more stocks of vac­cines from the two sus­pect batches. Those sold to Guizhou have not been used.

Guang­dong pur­chased 3,600 doses of the vac­cine, mostly in Zhong­shan and Guangzhou, and 190 of them have al­ready been ad­min­is­tered.

Guang­dong au­thor­i­ties said on Sun­day that 72 does were used in Zhong­shan with no ad­verse re­ac­tions ob­served so far. The rest of the batch has been sealed.

Zhang Jiansan, ex­ec­u­tive deputy man­ager of the vac­cine com­pany, told South­ern Me­trop­o­lis Daily in Guangzhou Satur­day that the two batches were pro­duced last year.

He said that an in­ter­nal in­ves­ti­ga­tion had re­vealed no prob­lems in the key ar­eas of man­u­fac­tur­ing, stor­age and trans­port.

Since the hep­ati­tis B vac­cine was in­cluded in China’s na­tional im­mu­niza­tion pro­gram in 2002, all Chi­nese ba­bies have been given the vac­cine free of charge.

Largely due to the pro­gram, the hep­ati­tis in­fec­tion rate among chil­dren un­der 5 years of age has been re­duced from 10 per­cent to less than 1 per­cent, ac­cord­ing to a World Health Or­ga­ni­za­tion re­port pub­lished in July.


A grand­mother smiles af­ter her grand­child, who had de­vel­oped ad­verse symp­toms af­ter be­ing vac­ci­nated for hep­ati­tis B, has re­sponded to treat­ment in Changde, Hu­nan prov­ince, on Thurs­day.

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