TOKYO: Following allegations of contamination in numerous vials, Japan has decided to prohibit the use of 1.63 million doses of Moderna’s Covid vaccine, according to pharmaceutical Takeda and the health ministry.
Takeda, the Japanese company in charge of the Moderna shot’s sales and distribution, claimed it has “received complaints from numerous immunization centers that foreign substances have been identified within unopened vials.”
“Following discussions with the health ministry, we have decided to cease the use of the vaccine” in three batches beginning Thursday, according to the statement.
Moderna had been notified, and the firm had “asked an urgent investigation,” according to the firm.
Moderna claimed in a statement that the observed contaminations were limited to “one product lot shipped in Japan.”
“Moderna believes the manufacturing issue arose in one of the lines used at its contract manufacturing facility in Spain,” the company said, adding that “no safety or efficacy issues have been detected thus far.”
Moderna has put this lot and two nearby lots on hold out of an abundance of caution,” it said, without explaining the nature of the contamination.
“We have not received any reports of health difficulties as a result of the foreign object,” said Katsunobu Kato, a top government spokesperson.
“However, if they feel any abnormalities, they should visit their doctors.”
According to national broadcaster NHK, contaminants were found in 39 unopened vials at eight immunization locations in central Japan, including Tokyo.
Doses from a halted batch were administered between August 6 and 20 at the defense ministry’s mass immunization center in Osaka, in western Japan.
However, before injecting the formula, employees visually inspect vials for impurities, according to the ministry, which added that its Tokyo immunization center was unaffected.
Batches of Moderna doses made by Rovi, a Spanish pharmaceutical business, were contaminated, according to reports. Rovi is one of Moderna’s vaccine manufacturing partners outside the United States.
Under the supervision of Spain’s pharmaceuticals agency AEMPS, Rovi was “investigating the origins of these quality concerns,” according to the Spanish health minister.
It noted in a statement that “all current evidence suggests that there are no further affected batches.”
Japan’s health ministry said it would work with Takeda to get alternate doses in order to avoid disrupting the country’s immunization programmed, which has been ramping up after a sluggish start.
Takeda declined to comment more, citing Moderna’s inquiry as a reason. However, a spokeswoman for the corporation stated that the company urged people to get vaccine shots.
As the country confronts a record spike of virus cases fueled by the more contagious Delta form, around 43% of Japan’s population has been properly vaccinated.