1.6m Moderna doses withdrawn in Japan over contamination

TOKYO/ NEW YORK -- About 1.6 million doses of Moderna's coronavirus vaccine have been taken out of use in Japan because of contamination reported in some vials, the Ministry of Health, Labor and Welfare said early Thursday.

Several vaccination centers have reported that vaccine vials contained foreign matter, according to an announcement from the ministry, which added it will seek to minimize the impact of the withdrawal on the country's inoculation program.

The ministry said later in the day that the substance that had been mixed in may have been metal. "It's a substance that reacts to magnets," a ministry official said. "It could be metal." Takeda Pharmaceutical handles distribution of the U.S.-developed Moderna vaccine in Japan.

Nasdaq-listed Moderna confirmed receiving "several complaints of particulate matter" in vaccine vials distributed in Japan but said it had found "no safety or efficacy issues" related to these reports.

"The company is investigating the reports and remains committed to working transparently and expeditiously with its partner, Takeda, and regulators to address any potential concerns," a Moderna spokesperson told Nikkei, saying the drugmaker believed a "manufacturing issue" at a plant in Spain was the cause.

The vaccine lot in question and two adjacent lots have been put on hold "out of an abundance of caution," the spokesperson said.

The Japanese ministry has not halted the use of Moderna vaccines in other batches, deeming them safe.

Prime Minister Yoshihide Suga told reporters on Thursday afternoon that he had instructed the ministry to look into the case with safety as the top priority, adding he had received reports that the withdrawal "won't have a significant impact on the country's vaccination campaign." The Moderna vaccine was granted emergency-use authorization in Japan in May.

Two people died after receiving Moderna Inc COVID-19 vaccine shots that were among lots later suspended following the discovery of contaminants, Japan's health ministry said on Saturday. The men in their 30s died this month within days of receiving their second Moderna doses, the ministry said in a release. Each had a shot from one of three manufacturing lots suspended on Thursday. The causes of death are being investigated.

Japan halted the use of 1.63 million Moderna doses shipped to 863 vaccination centres nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical Co , received reports of contaminants in some vials.

"At this time, we do not have any evidence that these deaths are caused by the Moderna COVID-19 vaccine," Moderna and Takeda said in a statement on Saturday. "It is important to conduct a formal investigation to determine whether there is any connection." The government has also said no safety or efficacy issues had been identified and the suspension of the three Moderna batches was a precaution.

Fumie Sakamoto, the infection control manager at St. Luke's International Hospital in Tokyo, cautioned against drawing a connection between the shots and the fatalities reported on Saturday. "There may only be a temporal relationship between vaccination and death," Sakamoto told Reuters. "There are so many things we still don't know to make any conclusions on these two cases."

The contaminants found in some vials in Japan are believed to be metallic particles, public broadcaster NHK reported, citing health ministry sources. Japan has administered more than 124 million COVID-19 vaccine shots, with about 44% of the population fully inoculated.

As of Aug. 8, 991 people had died in Japan after receiving shots of Pfizer Inc's vaccine and 11 after receiving Moderna's, but no causality between the injections and the deaths has been established, according to the health ministry. Adverse reactions have been reported at a frequency of 0.01% for the Moderna shot.

In the fatalities reported on Saturday, each man had a fever the day after his second dose and died two days after getting the fever. There has been no evidence that their shots contained contaminants, a health ministry official told reporters.

 

 

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