Japan halts use of 1.63 mln Moderna vaccine doses over contamination
Both Moderna and Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the vaccine in the country, said they had not received any reports regarding safety issues. Some of the 1.63 million doses distributed to 863 vaccination centers have already been administered.
«To date, no safety or efficacy issues have been identified,» Moderna told Kyodo News, adding it is «carefully assessing this matter and at this point does not have further comments on root causes.»
Regarding possible problems in other countries, the U.S. company said, «On an ongoing basis, Moderna monitors and expeditiously assesses questions we receive about our products from global markets.»
«Local authorities will make their own decisions about disclosure of information following these assessments,» the company said.
Prime Minister Yoshihide Suga told reporters, «I have been briefed by the health ministry that it will not have a significant impact,» when asked about the possibility of the suspension disrupting Japan's vaccination program.
The 1.63 million doses of Moderna vaccine were produced on the same production line at the same time in Spain, and fall under three lot numbers -- 3004667, 3004734 and 3004956, the health ministry said.
The Health, Labor and Welfare Ministry said it would ask each facility that received the doses not to use them.
The composition of the foreign materials, a few millimeters in size, has not been determined.
Foreign substances have been confirmed since Aug. 16 at vaccination sites in Tokyo and some other prefectures. The ministry said it received a report from Takeda on Wednesday.
The sites include the mass vaccination center operated by the Self-Defense Forces in Osaka, the Defense Ministry said.
Takeda has requested an emergency probe by Moderna, while urging medical institutions and other entities not to administer any of the vaccine showing abnormalities, even doses not subject to the suspension.
The Japanese company added it will make efforts to prevent the suspension from affecting the availability of coronavirus vaccine doses in the country.
The problem came to light at a time when Japan is struggling to contain a spike in coronavirus infections, with the government announcing a plan Wednesday to place eight more prefectures under its COVID-19 state of emergency.
While vaccinations against COVID-19 are under way in Japan, the highly contagious Delta variant of the coronavirus has sent daily reported cases surging in many parts of the country.
Over 10 million doses have already been administered in the country since the Moderna vaccine was approved for emergency use in May, according to the government.
The Japanese government signed a contract with Moderna to receive 50 million doses of the COVID-19 vaccine by the end of September. Currently people aged 12 and over can receive shots of the vaccine.
The vaccine, like the one developed by U.S. pharmaceutical company Pfizer Inc. and its German partner BioNTech SE, uses a new technology called messenger RNA, or mRNA, and is administered in two doses given four weeks apart.