The Ministry of Food and Drug Safety said it would recall the entire batch of percutaneous BCG vaccines imported from Japan, as Japan’s Ministry of Health, Labor and Welfare ordered to suspend shipments of the BCG vaccines.
A BCG vaccine prevents tuberculosis and is given to almost all newborns in Korea.
Japan’s health ministry said it detected an excessive level of arsenic in physiological saline, an attached solution to a BCG vaccine for dermal use, and discontinued shipments. Accordingly, Korea’s food and drug safety ministry ordered a recall of percutaneous BCG vaccines imported by Korea Vaccine from Japan.
Japan’s health ministry said although it detected arsenic in the saline, there would be no problem in safety, citing the health impact assessment by the state pharmaceutical and food safety research institute. Japan did not order a recall but suspension of shipments.
The Korean ministry said it would thoroughly review the Japanese authorities’ measure. As there is an alternative BCG vaccine in Korea, the government decided to recall the imported BCG vaccines, ministry officials said.
There are sufficient intradermal BCG vaccines as a substitute but getting the shot could be inconvenient because only a limited number of public health centers and designated hospitals provide the vaccination.
The ministry said the intradermal BCG vaccines are free, and those in stock can vaccinate more than 400,000 people by the first half of next year.
The list of 372 designated medical institutions that provide the intradermal BCG vaccination can be found on the homepage of the Korea Centers for Disease Control and Prevention (KCDC).
Guardians of infants and young children are advised to check the nearest public health center and a designated hospital in advance to make sure the intradermal BCG vaccination is available.