Japan investigates deaths of two people who received suspended Moderna doses

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The Japanese Ministry of Health is investigating the deaths of two men in their 30s after receiving the Covid-19 vaccines from Moderna which were part of the supplies which were then suspended due to a risk of contamination.

According to the ministry statement over the weekend, the two, who had no underlying conditions, died within three days of receiving their second injection of Moderna earlier this month.

There was no evidence the deaths were caused by the vaccines, but the ministry said it decided to disclose the cases to improve transparency.

“We are still investigating the cause but we must take preventive measures and we hope to release the information to the public as soon as we know it,” Norihisa Tamura, Minister of Health, said on a television broadcast on Sunday.

Japan last week decided to withhold 1.63 million doses of Moderna’s Covid vaccine following reports from several vaccination centers that the vaccine vials contained foreign bodies.

Officials said they had not identified any safety or efficacy issues, while Moderna said the suspension was decided “out of great caution.”

Three manufacturing batches were suspended, including one that contained contaminants and two other adjacent batches that were produced at the same location during the same period. Both men received their second hit from an adjacent lot.

In a joint statement, Moderna and its Japanese distribution partner Takeda Pharmaceutical said they take the deaths seriously. “At this time, we have no evidence that these deaths are caused by the Moderna Covid-19 vaccine, and it is important to conduct a formal investigation to determine if there is a link,” they said.

Rovi, the Spanish pharmaceutical company that is working with Moderna to make the Covid vaccine at a factory near Madrid, said the suspected contamination may have resulted from a “manufacturing incident” at one of its production lines. She added that the contamination affects some vials of a batch of products distributed exclusively in Japan.

Public broadcaster NHK recently said the source of the contamination could be a metal particle, citing unofficial reports from officials at Japan’s health ministry. But Moderna and Takeda said such reports were inconclusive: “It is important to rely on a formal investigation before determining the precise nature of the particle,” they said.

Over the weekend, Japanese media reported that a vaccination center on the southern island of Okinawa also discovered doses of Moderna vaccine containing foreign material, which were not among the three suspended batches. Okinawa prefectural government officials were not immediately available for comment.

The contamination incident came at a time when Prime Minister Yoshihide Suga has pledged to step up the country’s vaccination program to stem a record increase in coronavirus cases.

Despite a slow start, Japan has now administered 124 million doses of Covid vaccines, with around 43% of the population fully vaccinated.

According to the Department of Health, 1,002 people have died after receiving Covid vaccines as of August 8, including 11 as a result of Moderna jabs, but causality is unclear.