Japan’s Moderna vaccine contamination problems widen as regions put holds on more shots
- A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.
- Japan’s health ministry said some of the incidents may have been due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.
- Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centers nationwide after Takeda received reports of contaminants in some vials.
Moderna’s Covid-19 vaccine contamination woes in Japan widened after two regions put temporary holds on shots following the discovery of foreign substances in more batches.
The disruption to Moderna supplies comes as Japan battles its worst wave of Covid-19 yet, driven by the contagious delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine rollout.
The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting temporary holds on Sunday on shots from two new Moderna lots. That followed the nationwide suspension of 1.63 million doses last week.
A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.
Japan’s health ministry said some of the incidents may have been due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.
The ministry and Takeda Pharmaceutical, which distributes the Moderna vaccine in Japan, said there were no safety issues from the Okinawa and Gunma incidents and that there was no need for nationwide suspensions.
Gunma and Okinawa can resume using vials from the lots in question as long as they do not contain foreign materials, the ministry told a briefing late on Monday.
The contamination cases come on the heels of a government report on Saturday that two people died after receiving Moderna shots that were among lots later suspended.
The government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.
“It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths,” said Takahiro Kinoshita, a physician and vice chair of Cov-Navi, a vaccine information group.
“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.”
‘Look at the bigger picture’
Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centers nationwide after Takeda received reports of contaminants in some vials.
Some 500,000 people received shots from those supplies, Taro Kono, the minister in charge of the vaccine push, has said.
Moderna and Spanish pharma company Rovi, which bottles Moderna vaccines for markets other than the United States, said at the time that the contamination could be due to a manufacturing issue in one of Rovi’s production lines.
Rovi said, in a statement on Sunday, that an investigation was under way in coordination with Moderna, Takeda and the health authorities. Takeda also said, on Monday, that the investigation was ongoing.
Rovi shares closed down 13.5% on Monday.
Nicholas Rennick, an Australian doctor practicing at the NTT Medical Centre in Tokyo, said the contamination “is a serious problem” and there is need to investigate, but given rising Covid-19 cases, Moderna vaccinations should “continue with appropriate precautions.”
Severe Covid-19 cases are at record levels in Japan, leaving many people to recuperate at home amid a shortage of critical care beds. Only 44% of its population has been fully vaccinated, lagging vaccination rates of several developed countries.
“We’ve got thousands of Delta variant patients around Japan as we speak, spreading the virus, and so many of the population remain unvaccinated and unprotected,” Rennick said.
“We have to look at the bigger picture.”
Contaminants found in more Moderna COVID vaccine in Japan
(Mainichi Japan)
TOKYO (Kyodo) -- The Gunma prefectural government said Sunday that foreign substances were discovered in Moderna Inc.'s COVID-19 vaccine, the latest in a series of contaminants in the company's product reported in Japan over the past several days.
Blackish foreign matter, less than 0.5 millimeters in size, was spotted during pre-inoculation inspections in a vial that has a different lot number from those of the three lots suspended Thursday for use and another found Saturday in Okinawa containing black and pink substances.
About 4,500 people received shots in Gunma under the lot number over the three days through Sunday but no cases of ill health have been reported, the local government said.
Gunma becomes the seventh prefecture to report the discovery of foreign matter in the Moderna vaccine following Ibaraki, Saitama, Tokyo, Gifu, Aichi and Okinawa.
All the seven are among 21 prefectures, out of the total 47, currently under a COVID-19 state of emergency, as Japan is struggling to contain a spike in coronavirus infections.
The same day, the Okinawa prefectural government said it halted inoculations at a mass vaccination site in Naha following the discovery of contaminants in a vial and three syringes filled with vaccine from three different vials.
These four vials fall under the same lot number -- 3005293 -- which is different from the three other lot numbers identified by Japan's health ministry Thursday as potentially contaminated doses.
The Health, Labor and Welfare Ministry said Sunday that rubber pieces have likely fallen into the vials when a syringe needle was inserted into the rubber top of the vials. The ministry has found no major problem in vaccine quality, it added.
The ministry said it consulted with Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the Moderna vaccine in the country, and decided there is no need to halt the use of the batch as there are no major safety issues.
About 880 people received shots in Okinawa under the lot number and the local government has not received any reports of health issues.
The contaminant issue started Thursday when the ministry said foreign substances have been confirmed in 39 unused vials at eight vaccination sites in Ibaraki, Saitama, Tokyo, Gifu and Aichi.
The ministry the same day halted the use of around 1.63 million doses of the three lots, which came from a Spanish manufacturer for Moderna, as a precaution.
Moderna launched a probe into the three lots -- 3004667, 3004734 and 3004956 -- while urging medical institutions and other entities not to administer any vaccine showing abnormalities, even doses not subject to the suspension.
The Okinawa government said it will resume inoculating people at the site on Monday and Gunma restarted vaccination at the center Sunday, both by using unaffected vaccine.
Contaminants found in more Moderna COVID vaccine in Japan
(Mainichi Japan)
TOKYO (Kyodo) -- The Gunma prefectural government said Sunday that foreign substances were discovered in Moderna Inc.'s COVID-19 vaccine, the latest in a series of contaminants in the company's product reported in Japan over the past several days.
Blackish foreign matter, less than 0.5 millimeters in size, was spotted during pre-inoculation inspections in a vial that has a different lot number from those of the three lots suspended Thursday for use and another found Saturday in Okinawa containing black and pink substances.
About 4,500 people received shots in Gunma under the lot number over the three days through Sunday but no cases of ill health have been reported, the local government said.
Gunma becomes the seventh prefecture to report the discovery of foreign matter in the Moderna vaccine following Ibaraki, Saitama, Tokyo, Gifu, Aichi and Okinawa.
All the seven are among 21 prefectures, out of the total 47, currently under a COVID-19 state of emergency, as Japan is struggling to contain a spike in coronavirus infections.
The same day, the Okinawa prefectural government said it halted inoculations at a mass vaccination site in Naha following the discovery of contaminants in a vial and three syringes filled with vaccine from three different vials.
These four vials fall under the same lot number -- 3005293 -- which is different from the three other lot numbers identified by Japan's health ministry Thursday as potentially contaminated doses.
The Health, Labor and Welfare Ministry said Sunday that rubber pieces have likely fallen into the vials when a syringe needle was inserted into the rubber top of the vials. The ministry has found no major problem in vaccine quality, it added.
The ministry said it consulted with Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the Moderna vaccine in the country, and decided there is no need to halt the use of the batch as there are no major safety issues.
About 880 people received shots in Okinawa under the lot number and the local government has not received any reports of health issues.
The contaminant issue started Thursday when the ministry said foreign substances have been confirmed in 39 unused vials at eight vaccination sites in Ibaraki, Saitama, Tokyo, Gifu and Aichi.
The ministry the same day halted the use of around 1.63 million doses of the three lots, which came from a Spanish manufacturer for Moderna, as a precaution.
Moderna launched a probe into the three lots -- 3004667, 3004734 and 3004956 -- while urging medical institutions and other entities not to administer any vaccine showing abnormalities, even doses not subject to the suspension.
The Okinawa government said it will resume inoculating people at the site on Monday and Gunma restarted vaccination at the center Sunday, both by using unaffected vaccine.
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