Monday, August 30, 2021

Big Pharma > Moderna - 2 Batches Contaminated, 2 Dead; Now 7 Prefectures Discover Contaminants - 2.6 Million Doses Pulled

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Moderna vaccinations halted in Japan’s Okinawa after ‘black substances’

found in vial, days after other batch of jab was suspended

29 Aug, 2021 08:33

©  AFP / HAZEM BADER


Okinawa prefecture has halted Moderna vaccinations after unknown materials were found in a vial of the drug. The move comes after Japan pulled 1.6 million Moderna doses from a different batch over contamination concerns.

Black substances were discovered in syringes and a vial, while unidentified pink substances were spotted in a different syringe with a Moderna vaccine dose, according to Japan’s public broadcaster, NHK. 

Okinawa’s government said in a statement on Sunday that it was suspending the use of Moderna vaccines after “foreign substances were spotted in some of them.

Takeda Pharmaceutical, Japan’s domestic distributor of the Moderna shot, is expected to probe whether the suspected contamination occurred during production and will consult with the health ministry on the matter, NHK reported. 

The discovery comes just three days after Japan suspended the use of more than 1.6 million Moderna doses that had been distributed to 863 vaccination centers around the country. The doses were temporarily pulled from circulation as a precautionary measure after foreign material was discovered in some vials. Some of the doses were reportedly contaminated with metal particles. The newly discovered contaminated doses in Okinawa are from different vaccine lots. 

Two Moderna recipients died


While the issue is still being investigated, Japan’s Health Ministry revealed on Saturday that two people who had received their second Moderna doses from the vaccine lots withdrawn earlier this week had died. The ministry said it was investigating what killed the two victims, both men in their 30s, and that it was currently unknown if the vaccine played a role. 

The vials from the pulled batches, which were manufactured by a Moderna contractor in Europe, are currently undergoing laboratory analysis. The results will be available early next week, Moderna and Takeda said in a joint statement released on Saturday. 

On Friday, Taro Kono, the minister in charge of Japan’s immunization campaign, disclosed that more than 500,000 vaccinations had already been carried out using the doses from the vaccine lots in question. So far, there doesn’t appear to be any “serious safety issues” identified, Kono said. 

The European Medicines Agency (EMA) has launched its own probe to determine if the EU’s Moderna supply suffers from similar contamination problems. 




Japan suspends Moderna Covid vaccine after another million doses

found contaminated, bringing total to 2.6 million

30 Aug, 2021 10:41

© Reuters / Dado Ruvic


Japanese officials have suspended the use of millions of doses of the Moderna Covid vaccine after foreign substances were found in a number of batches and two people died after receiving jabs from the affected lots.

The Japanese government discovered the contamination over the weekend in a batch of the Moderna Covid vaccine in Gunma prefecture, close to Tokyo, forcing officials to temporarily suspend use of the vaccines.

The decision to suspend a total of 2.6 million doses of the Moderna vaccines comes after 1.63 million shots were halted last week following the discovery of contaminants in some vials in a batch that was shipped to more than 860 vaccination centers across the country.

While the source of the contamination has not been confirmed, Moderna and pharmaceutical company Rovi, which manufactures the Moderna vaccines, said that it could be due to a manufacturing fault on one of the production lines, rather than anything more concerning.

So much for quality control! Rovi's head office is in Madrid; I don't know where they manufactured the Moderna vaccine.

The country’s health ministry has confirmed that two individuals who were vaccinated using doses from the batch have died. However, the cause of death in both cases is under investigation and officials claim that no safety concerns have been identified yet. In a statement, Moderna and Japanese distributor Takeda stated that “we do not have any evidence that these deaths are caused by the Moderna COVID-19 vaccine.”

Gunma is now the seventh Japanese prefecture to discover contaminants in doses of the Moderna vaccine, after similar incidents in Aichi, Gifu, Ibaraki, Okinawa, Saitama and Tokyo. It comes as Japan battles a surge in Covid cases that has pushed nearly half of the country’s prefectures into a state of emergency.

Since the start of the pandemic, Japan has recorded 1.38 million confirmed cases of Covid and 15,797 fatalities from the virus. So far, Japanese officials have administered 118,310,106 doses of a Covid vaccine. 



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