Drug reg­u­la­tor takes flak for be­lated vac­cine re­call

The Korea Times - - NATIONAL - By Kim Hyun-bin hyun­bin@ko­re­atimes.co.kr

Health of­fi­cials are un­der fire for their be­lated re­sponse to the Ja­panese-made per­cu­ta­neous BCG vac­ci­na­tion, which was found to have ar­senic ex­ceed­ing Ja­pan’s daily limit.

Ar­senic is a Cat­e­gory 1 car­cino­gen whose pres­ence in the hu­man body can re­sult in the devel­op­ment of cancer.

The crit­i­cism comes as the Min­istry of Food and Drug Safety re­sponded three months af­ter the Ja­panese gov­ern­ment’s re­port that the prod­uct con­tained too much ar­senic.

The Ja­panese Drug and Safety min­istry said there were no safety haz­ards with the vac­ci­na­tion, but it banned its man­u­fac­ture.

Korea Vac­cine, the im­porter of the Ja­panese BCG vac­cine, says it wasn’t a late re­sponse claim­ing the Ja­panese com­pany only in­formed them last month and they re­ported to the Min­istry of Food and Drug Safety as soon as they re­ceived the in­for­ma­tion.

Ac­cord­ing to the min­istry Thurs­day, the ar­senic found in the vac­cine was 0.039 mi­cro­grams (0.26ppm), which is 1/38 of the daily limit. The Ja­panese gov­ern­ment claims the BCG vac­ci­na­tion could be taken daily for the du­ra­tion of a per­son’s life and en­counter no prob­lems.

BCG vac­cines are only taken once in a life­time, which is the rea­son the Ja­panese drug min­istry did not re­trieve al­ready dis­trib­uted vac­cines from stores.

The In­ter­na­tional Coun­cil for Har­mon­i­sa­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH) al­lows a daily dose of 1.5 mi­cro­grams per five kilo­grams in weight, but the dose lim­its are much stricter in Ja­pan.

Korea’s drug safety min­istry also stands by the ICH eval­u­a­tion and says the vac­cine is not harm­ful, but the min­istry re­called over 142,000 prod­ucts na­tion­wide, Wed­nes­day.

Korea Vac­cine says it was aware of the Ja­panese gov­ern­ment’s an­nounce­ment to stop man­u­fac­tur­ing the drug in Au­gust, but did not re­ceive any in­for­ma­tion about ar­senic con­tent of the prod­uct.

“At the time, the Ja­panese man­u­fac­turer has been wait­ing for the re­sponse from its drug min­istry. There were no prob­lems in the li­cense so we waited for the re­sults. We re­ceived the re­sults mid-Oc­to­ber,” an of­fi­cial at the Korea Vac­cine told Yon­hap News. “Once we re­ceived the doc­u­ments we trans­lated them and re­ported to the min­istry.”

The min­istry also claims it re­acted swiftly.

“On Nov. 5, we found the Ja­panese drug min­istry’s stance, and on the same day Korea Vac­cine in­formed us of the re­sults,” a min­istry of­fi­cial said. “We thor­oughly looked into Ja­pan’s mea­sures and we or­dered all prod­ucts to be re­trieved in the coun­try.”

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