Drug regulator takes flak for belated vaccine recall
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.”