Bad doses of baby vac­cine are re­called

Two com­pa­nies re­leased thou­sands of in­ef­fec­tive in­oc­u­la­tions for new­borns

China Daily (Latin America Weekly) - - 4 China - By JIANG CHENGLONG jiangchen­g­long@ chi­

More than 650,000 doses of a vac­cine rou­tinely given to new­borns in China have been re­called af­ter test­ing showed they were in­ef­fec­tive.

The prob­lem with the vac­cine, which im­mu­nizes against diph­the­ria, per­tus­sis (whoop­ing cough) and te­tanus, was iden­ti­fied af­ter batches were dis­trib­uted in Shan­dong and He­bei prov­inces and in Chongqing.

Some doses were ad­min­is­tered be­fore the re­call, “which might di­min­ish the im­mu­niza­tion ef­fect but will not threaten peo­ple’s health”, the China Food and Drug Ad­min­is­tra­tion said in a state­ment on Fri­day.

The re­call re­lates to batches from two com­pa­nies: Chang­sheng Biotech­nol­ogy in Jilin prov­ince, which sent 252,600 doses to Shan­dong; and the Wuhan In­sti­tute of Bi­o­log­i­cal Prod­ucts in Hubei prov­ince, which sent 190,520 doses to Chongqing and 210,000 doses to He­bei.

Un­der the Drug Ad­min­is­tra­tion Law, vac­cines must be checked for safety and ef­fi­cacy be­fore they can enter the mar­ket.

The Na­tional In­sti­tutes for Food and Drug Con­trol, which car­ries out pre­mar­ket checks, tested the DPT vac­cines ac­cord­ing to nor­mal in­ter­na­tional prac­tice, and re­ported no is­sues, the FDA said. How­ever, the in­ef­fec­tive vac­cines were not iden­ti­fied. A later rou­tine check found the vac­cines’ “titer” — a mea­sure of the con­cen­tra­tion of an­ti­bod­ies — of both com­pa­nies’ prod­ucts to be sub­stan­dard.

In­ves­tiga­tive teams have been sent to check com­pli­ance at the com­pa­nies’ pro­duc­tion bases and will spend six to eight weeks test­ing the qual­ity of all vac­cines.

The Na­tional Health and Fam­ily Plan­ning Com­mis­sion and pro­vin­cial health de­part­ments have also sent ex­perts to as­sess stocks of the vac­cine to en­sure that rou­tine im­mu­niza­tion pro­grams con­tinue.

Af­ter the DPT vac­cine was in­cor­po­rated into China’s im­mu­niza­tion pro­gram in the 1970s, the rates of diph­the­ria, per­tus­sis and te­tanus have fallen steadily, ac­cord­ing to the FDA.

“There has been no diph­the­ria cases re­ported since 2007, and the an­nual in­ci­dence of per­tus­sis has dropped to less than 0.5 per 100,000 peo­ple now, com­pared with 100 to 200 per 100,000 in the 1970s,” the state­ment said.

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