Korea Vaccine has emerged as the center of controversy, as it is involved in the recent fire of low-cost dormitory-style building in Seoul, following a scandal concerning its import of arsenic-laced BSG vaccines from Japan.
The Ministry of Food and Drug Safety recently ordered the recall of the entire patch of percutaneous BCG vaccines, after it detected an excessive level of arsenic in physiological saline, an attached solution to a BCG vaccine for dermal use.
A BCG vaccine presents tuberculosis and is given to almost all newborns in Korea.
The products in question were manufactured by BCG Laboratory JBL of Japan and imported and supplied to Korea by Korea Vaccine
According to the ministry, arsenic detected from the physiological saline of the percutaneous BCG vaccines was 0.039ug (0.26 ppm) at most, one thirty-eighth of the daily permissible level.
Arsenic is a highly toxic heavy metal and can peripheral neuropathy or cancer, designated by International Agency for Research on Cancer as the first-group carcinogen. However, the Korean ministry says the detection is not worrisome as most of it is excreted through urine within 72 hours.
Still, voices of distrust and anger mounted particularly among parents of babies and infants, which showed the signs of directing to the importer of the tainted vaccines, forcing Korea Vaccine to try to calm down the unrest by publishing related contents on its website.
Through a Q&A page on physiological saline of percutaneous BCG vaccines, the company said Koreans’ daily intake of arsenic through food in 2014 stood at 144.96ug in 2014, with that of inorganic arsenic remaining at 10ug, about 256 times more than the 0.039ug, detected from the physiological saline of percutaneous BCG vaccines.
Arsenic is commonly included in the food Korean take every day, including rice, other grains, vegetables, fruits, fish and shellfish, thus the detected level of the metal would have no damage on health, it said.
Also, when medical workers administer transdermal BCG, they drop one or two drops of vaccine suspension using a spuit, spread evenly on vaccination area, and make a slit with a needle so that the spread vaccine suspension can be naturally absorbed through the needle mark.
“The amount of one drop of spuit is about 0.03 mL, and two drops is 0.06 mL. Assuming that all the two drops enter into the body, the volume of arsenic is 0.016ug, but medical workers spread evenly percutaneous BCG on vaccination part (1.5 centimeters in width and about 3 cm in length) and make it be observed through a minute needles mark so that the amount of arsenic that enters into the body is tiny and far smaller than 0.016ug,” the company said.
The detection has nothing to do with the efficacy of the BCG vaccine, and the company recalled the products voluntarily, Korea Vaccine added.
As soon as the controversy over arsenic detection appeared to calm down, another accident broke out in an unexpected place – the fire in the dosshouse in Jong-no, downtown Seoul, last Friday.
According to media reports, the owner of the flophouse is Chairman Ha Chang-hwa of Korea Vaccine and his family members. Ha bought the building in June 2000 and owns about 40 percent of it with the other 60 percent of equity held by his younger brother.
Chairman Ha immediately said he would take moral, if not legal, responsibility for the disaster. The local administration told the building to install sprinklers, but the administrative instruction was not fulfilled, allegedly due to the lack of agreement by the building’s owners.
The controversy will likely continue for the time being, because the failure to install sprinklers has been behind the fires at mass accommodation facilities and resultant deaths and injuries, and the police made it clear they would summon and investigate its owners if they are found to be responsible for the accident in anyways.
Korea Vaccine, founded in 1956, is a company that researches, develops and supplies vaccines and medical devices, including syringes and catheters. It received the presidential medal for technological excellence and national award. It has made partnerships with multinationals such as Novartis, Pfizer and Sanofi Pasteur as well as domestic drugmakers, including Ilyang Pharm.
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