Japan’s health ministry announced that two citizens had died within days of receiving the second shot of Moderna’s COVID-19 vaccine. The victims, both men in their thirties, were injected with doses belonging to a suspended lot.
On Aug. 16, Takeda Pharmaceutical Co, Moderna’s distributor in Japan, reported that 39 vials of the vaccine contained foreign material. They were from a lot that contained 57,000 vials, or about 570,000 doses. Ten days later on Aug. 26, Tokyo announced that it had suspended the use of 1.63 million doses of Moderna sent to 863 vaccination centers.
The suspended doses from lot 3004667 contained 39 contaminated vials. Two similarly sized lots, 3004734 and 3004956, were also suspended. The contaminants were suspected to be metallic particles. Rovi, the Spain-based company that bottles Moderna vaccine for markets other than the U.S., stated that one of its production lines might be responsible for the “manufacturing incident.”
On Aug. 28, the death of the men was announced. One man, 38 years old, and the other, 30, had received a shot each from the suspended 3004734 lot and spiked a fever on the same day they were vaccinated. They died two days later.
According to an official from the health ministry, there was no evidence that the shots were contaminated. The cause of death is still being investigated. “It is important to conduct a formal investigation to determine whether there is any connection,” Moderna and Takeda said in a statement.
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On Aug. 29, a vaccine center in Gunma prefecture reported a tiny, black substance in a vial from lot 3005236. The government immediately suspended the affected lots, which amounted to 1 million doses. In total, Japan has suspended 2.63 million doses of Moderna due to concern of contamination.
According to the health ministry, some of the contamination was caused due to incorrectly inserting needles into the vials. This causes bits of the rubber stopper to break off. Around 500,000 people have been vaccinated using doses from the initially suspended three lots of the Moderna vaccine. 4,575 people in the Gunma prefecture were given doses from the fourth lot.
In an interview with Reuters, Takahiro Kinoshita, a physician and vice-chair of Cov-Navi, a vaccine information group, stated that it was unlikely that the two deaths were caused by foreign substances.
“If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination… However, further investigations are definitely needed to evaluate the harm of the particular doses in question,” Kinoshita said.
Nicholas Rennick, an Australian doctor practicing at the NTT Medical Centre in Tokyo, called the contamination a “serious problem” that required investigation. Although he supported the continued use of Moderna vaccines, Rennick stated that “appropriate precautions” must be taken.
Japan has administered over 124 million vaccine shots. 44 percent of the country has been fully vaccinated. As of Aug. 8, 1,002 people have died after receiving vaccines. While only 11 of the deaths were accounted for by Moderna, the remaining 991 were those who had received Pfizer jabs. The health ministry stated that no causality has been established between vaccine injections and deaths. Adverse reactions to Moderna vaccines have been reported at a rate of 0.01 percent.
According to a study published in The Lancet in September last year, Japan has one of the lowest confidence rates in the world when it comes to the effectiveness and safety of vaccines. It speculates that the public’s view on vaccine safety might have been negatively impacted after the government withdrew its recommendation of an HPV vaccine in 2013.
The number of daily new confirmed COVID-19 cases per million people in Japan has surged from 6.85 on June 21 to 153.99 on June 29, a 21-fold increase. The number of deaths during the period rose from 0.10 to 0.40 deaths per million people. This rise in infections and deaths occurred despite the proportion of fully vaccinated individuals jumping from 23.84 to 45 percent during this time.
Taro Kono, the Japanese minister in charge of the nation’s vaccine rollout campaign, recently stated that the government plans to fully vaccinate the country’s population by October or November this year. Since the start of the pandemic, Japan has registered more than 1.4 million cases of COVID-19 infections and around 16,000 deaths.