Japan has suspended 1.63 million Moderna Inc. (NASDAQ: MRNA) COVI-19 vaccine doses over a week following reports that some vials were contaminated.
Moderna investigating contaminated COVID-19 vaccine doses
The company and Japanese authorities indicated no efficacy or safety issues were identified so far, and this suspension is just a precaution. However, following the suspension, various companies have canceled planned worker vaccinations and resulted in European drug regulators investigating the issue.
In a statement, the company confirmed that it had received notification regarding instances where the particulate matter was observed in COVID-19 vaccine drug vials. As a result, Moderna said it had put the drug lot in question and adjacent lots on hold. Additionally, the company confirmed that it is probing the issue, and it is committed to expediting the investigation with regulators and partner Takeda Pharmaceuticals to address the issue. Takeda is responsible for the distribution of the Moderna vaccine in Japan.
Takeda discovered the compromised vials on August 16, 2021, and informed the government on Wednesday, according to a Health Ministry official. But, the ministry official said, Takeda required more time to collect data regarding the contaminated vials and locations where they are in the country.
Contaminated doses meant for Japan
According to Moderna and Spanish pharmaceutical company Rovi, the contamination could be related to a production fault in one of Rovi’s manufacturing lines. Rovi said it was investigating the issue and “trying to give all details.” According to the company, the batch in question was solely intended for distribution in Japan, and two other batches prepared before and after it were kept aside for safety reasons.
The European Medicines Agency (EMA) is looking into the contamination to determine whether it had an effect on EU supplies. So far, Moderna has delivered around 70 million doses of the vaccine to the EU, and the company has a contract to supply the EU with 460 million doses.