As the Group 1 carcinogen arsenic was detected in Japanese Bacillus Calmette-Guerin (BCG) vaccines for infants under the age of 1, South Korean health authorities decided to recall the entire batch of BCG vaccines being circulated in Korea, which amounts to 140,000, and investigate the health risks associated with it.
The South Korean Ministry of Food and Drug Safety announced on Wednesday that “stamp” type BCG vaccine sets imported from Japanese pharmaceutical company JBL contained up to 0.23ppm of arsenic, exceeding Korea’s standard of 0.1ppm. Arsenic is a toxic heavy metal, classified as group 1 carcinogen by the International Agency for Research on Cancer (IARC) as it can cause peripheral nerve disorder or bladder cancer if exposed excessively.
There are only two types of BCG vaccines Korea imports overseas: one is a “stamp” type vaccine manufactured by JBL of Japan and the other is an intradermal-type vaccine manufactured by AJ of Denmark. The “stamp” type vaccine has been used in Korea four times more than the other as it is easier to use to infants. The “stamp” type vaccines made by JBL is not included in the national immunization program but more than 240,000 infants were inoculated with the vaccine between October last year and June this year as there were not enough intradermal-type vaccines. Currently, only the intradermal-type vaccines are included in the national immunization program.
After the Korean health ministry's announcement, the Ministry of Health, Labor and Welfare of Japan said that there are no safety problems, citing reasons that the maximum amount of arsenic detected was only 1/38 of the ICH (International Conference on Harmonization) standard and the “stamp” type vaccines only allow a minimum amount of arsenic to enter into the body. The Japanese government suspended shipments of the products in question but did not recall them.
Gun-Hee Cho firstname.lastname@example.org