- After Japanese domestic distributors received reports of contamination of some vials, Japan has suspended the use of Moderna Covid-19 vaccine.
- No safety or effectiveness issues were found.
- Moderna stated that the pollution may be due to manufacturing problems in a production line at its Spanish contract manufacturing base.
Japan suspended 1.63 million doses of Moderna Inc’s Covid-19 vaccine on Thursday, more than a week after domestic distributors received reports of contaminants in certain vials.
Both Japan and Moderna stated that no safety or effectiveness issues were found and the suspension was only a preventive measure.
But the move prompted several Japanese companies to cancel the vaccines that were originally scheduled to be vaccinated for workers on Thursday, and led the European drug regulatory agency to investigate the matter.
The U.S. vaccine manufacturer said in a statement: “Moderna has confirmed that it has been notified that there have been cases of particulate matter in the drug vials of its Covid-19 vaccine,” the U.S. vaccine manufacturer said in a statement. And added that it put the batch and two adjacent batches on hold.
“The company is investigating these reports and remains committed to its partner Takeda and regulatory agencies to work quickly to resolve this issue,” it added, referring to Japan’s Takeda Pharmaceuticals, which distributes vaccines in the country.
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A Ministry of Health official said that Takeda first discovered the contaminated medicine bottle on August 16 and reported the problem to the government on Wednesday.
The official said the delay was because Takeda needed time to gather information about which medicine bottles were affected and where they were in the country.
Moderna stated that the pollution may be due to manufacturing problems in a production line at its Spanish contract manufacturing base.
The European Medicines Agency (EMA) said it is investigating the pollution incident and is assessing whether it will have an impact on EU supplies.
The agency said in a statement to Reuters: “EMA is investigating this matter and has requested marketing authorization holders to provide information on any potential impact of the batches supplied to the EU, as well as the ongoing root cause investigation. The details of.”
Public data from the European Union shows that, so far, Moderna has delivered more than 70 million doses of Covid-19 vaccine to the European Union. The company has signed two contracts with groups in 27 countries, with a total supply of 460 million pieces.
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A Moderna spokesperson stated that the affected production batches, plus the other two batches, are out of cautious consideration because they are processed before and after the affected batches and are therefore only distributed in Japan.
The Spanish pharmaceutical company Rovi bottled or “filled and completed” Moderna vaccines for markets outside the United States. The company said it is investigating possible contamination of Moderna doses. The problem appears to be limited to a few batches of vaccines shipped to Japan.
Rovi’s stock price fell 4.6%.
The suspension of production is a new setback for Moderna, whose partners delayed production last month, interrupting supplies to countries including South Korea.
The Ministry of Defense of Japan, which operates a large-scale vaccination site in Osaka, said that this batch of vaccines had been used in the western region from August 6 to August 20, including 565,400 doses of vaccine, but it did not specify how many people were vaccinated. The vaccine. pretentious.
Japanese airline ANA stated that it has used approximately 4,700 moderna vaccines that have been discontinued and will stop all vaccinations planned on Thursday.
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Competitor Japan Airlines also cancelled some Covid-19 vaccines for its employees on Thursday after receiving the Moderna vaccine containing particulate matter.
Although several companies have cancelled planned vaccination, Japanese Prime Minister Yoshihide Suga said that the country’s vaccination plan will hardly be affected by the problem.
A day ago, he said that by the end of September, about 60% of the public will be fully vaccinated and that the country has enough vaccine to provide a booster dose.
The decision to suspend the use of the Moderna vaccine was an awkward moment for Suga, and his government was criticized for the slow launch of the vaccine campaign earlier this year. He faces challenges in the leadership competition within the party, and his approval rating has dropped below 30%.
Japan is battling the worst infection wave driven by the Delta variant, with new daily infections exceeding 25,000 for the first time this month. According to Reuters vaccine trackers, it has vaccinated 54% of the population with at least one dose and 43% of the population.
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