Japan earlier halted the use of 1.7 million Moderna doses, shipped to 863 vaccination centers nationwide after Takeda received reports of contaminants in some vials. 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. Low quality 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 1.7 million doses last week.
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. “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.
“To date, no safety or efficacy issues have been identified,” Moderna said, adding that it would work with regulators and Takeda to investigate the matter further.
There are no details of what the “foreign objects” are, but Takeda described it as particulate matter, after which it said conducted an emergency examination.
Reports of contamination also came from seven other vaccination centres, according to the Japan Times newspaper, with 39 vials – or 390 doses – found to have been affected.
The health ministry has published the batch numbers so that people who had received their shot before the suspension could check if they have got a potentially contaminated shot, Japan Times added.
Japan is battling a spike in Covid cases, with eight more prefectures placed under a state of emergency on Wednesday.
Its capital, Tokyo, is currently hosting the Paralympic Games.
The country has already approved the Pfizer and AstraZeneca vaccines for use – it only started using Moderna in May.
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