Japan monitors vaccine safety amid Moderna probe
Tokyo, Sep 2 (EFE).- Japan said Thursday that it is continuing to monitor possible reactions in patients to Moderna’s Covid-19 vaccine after the company said that the stainless steel particles found in some of its doses did not pose a medical risk.
On Wednesday, Moderna released the results of its investigation into the foreign substances detected in batches of its vaccines manufactured in Spain and distributed in Japan.
It identified the substances as stainless steel particles due to a technical failure in the production line of its Spanish supplier, Rovi.
The contamination “does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product,” Moderna said in a joint statement with its distributor in Japan, Takeda, and which was echoed by the Japanese government’s top spokesperson, Katsunobu Kato on Thursday.
Kato said at a press conference that the impact of this issue on Japan’s vaccination campaign will be “minimal.”
He said that alternative supplies have been secured to replace the 1.63 million doses that were shelved when the impurities were detected.
The withdrawn vaccines corresponded to three batches produced at the same time and in the same Rovi plant and were suspended as a precautionary measure after “abnormal substances” were found in some vials of one of the three batches.
The Japanese authorities are also investigating the death of two people who were vaccinated with doses from one of the batches before they were withdrawn to determine whether there was any connection between the deaths and the inoculations.
In their statement on Wednesday, Takeda and Moderna said that there is no evidence so far that the deaths were caused by vaccines, although they stressed the importance of conducting a formal investigation.
A health ministry spokesperson told EFE on Thursday that possible reactions to Moderna’s vaccine continue to be analyzed by experts monitoring the safety of Covid drugs.
The spokesperson did not wish to comment on whether the Japanese authorities are contemplating imposing some type of sanction on pharmaceutical companies for contamination in vials. EFE
ahg-yk/pd/tw
