China Daily

Shortage ham­pers in­oc­u­la­tions of in­fants

- By WANG XIAODONG wangx­i­aodong@ chi­nadaily.com.cn Health · Pharmaceutical Industry · Medical Activism · Anti-Vaccers · Medicine · Vaccines · Industries · Alternative Medicine · Medical Treatments · Beijing · U.S. Food and Drug Administration · Yao

Sup­plies of a pop­u­lar com­bi­na­tion vac­cine for in­fants used to pre­vent five in­fec­tious dis­eases have run out in many Chi­nese cities. Au­thor­i­ties in Bei­jing are tak­ing mea­sures to get more.

The vac­cine — a mixed prod­uct that vac­ci­nates against five dis­eases — is the only such prod­uct avail­able on the Chi­nese main­land, and is used for chil­dren younger than 18 months to pre­vent diph­the­ria, tetanus, per­tus­sis, po­lio and Hib, ac­cord­ing to the China Food and Drug Ad­min­is­tra­tion.

Called Pen­taxim, it is pro­duced by French phar­ma­ceu­ti­cal com­pany Sanofi.

While Pen­taxim is gen­er­ally ap­proved for im­port, some re­cent batches failed to pass in­spec­tions by food and drug reg­u­la­tors and were barred from sale in the do­mes­tic mar­ket. Im­ports of the vac­cine have been tem­po­rar­ily sus­pended, ac­cord­ing to a state­ment by the Bei­jing Cen­ter for Dis­ease Pre­ven­tion and Con­trol on Dec 7.

Pen­taxim has been avail­able in the Chi­nese mar­ket since May 2011, the CFDA said. It re­quires four in­jec­tions to com­plete a full pro­ce­dure — three be­fore a child is 5 months old, and the fi­nal one at 18 months, it said.

Clin­i­cians mix liq­uid and pow­dered parts of the prod­uct be­fore each in­jec­tion. All in­jec­tions are iden­ti­cal.

Pen­taxim is a Cat­e­gory 2 vac­cine, which means it is des­ig­nated for vol­un­tary pur­chase rather than provided free to the pub­lic.

Sev­eral other vac­cines can be used in com­bi­na­tion as a sub­sti­tute, in­clud­ing po­lio and diph­the­ria vac­cines, which are Cat­e­gory 1 vac­cines, the ad­min­is­tra­tion said ear­lier.

Yao Xi­u­jun, a spokesman for the Bei­jing Health and Fam­ily Plan­ning Com­mis­sion, noted on Mon­day that Pen­taxim has been in short sup­ply in many parts of China, and health au­thor­i­ties in Bei­jing have placed an emer­gency or­der to serve 30,000 in­fants.

Vac­cines that are in stor­age in Bei­jing will be used for chil­dren who have al­ready be­gun the in­oc­u­la­tion se­ries, he said.

In a state­ment provided to China Daily on Mon­day, Sanofi said de­mand for the vac­cine in China has been in­creas­ing at a rapid rate in re­cent years due to its safety and con­ve­nience, and that has con­trib­uted to sup­ply short­ages.

Eight batches of the prod­uct failed to pass in­spec­tion by Chi­nese au­thor­i­ties, which wors­ened the shortage, the com­pany said. It added that it has been com­mu­ni­cat­ing with health au­thor­i­ties to ad­dress the prob­lem.

Pro­duc­tion of com­bi­na­tion vac­cines is more com­pli­cated than other vac­cines, with a pro­duc­tion cy­cle as long as 18 months to three years, the com­pany said.

“Sup­plies of Pen­taxim will re­main short in the fore­see­able fu­ture,” it said.

All the com­pany’s vac­cines avail­able in the Chi­nese mar­ket are safe and ef­fec­tive, as they must pass in­spec­tions by drug au­thor­i­ties both at their point of ori­gin and in China be­fore they can cir­cu­late, the com­pany said.

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