The authorities of the country and representatives of the company emphasize that this is only a precautionary measure.
Japan on Thursday suspended the use of 1.63 million doses of the Moderna vaccine after a local distributor received reports of polluting impurities in some vials.
Both the Japanese authorities and representatives of Moderna say that no problems with the safety or effectiveness of the vaccine have been identified, and the suspension is just a precautionary measure. But the move prompted several Japanese companies to cancel a planned vaccination of employees on Thursday, and the European medicines regulator has launched an investigation into this.
“Moderna confirms that it has received reports of cases of solid particles being detected in vials of the COVID-19 vaccine drug,” the American pharmaceutical company said in a statement. It is also reported that the use of this batch and two adjacent ones have been suspended.
“The company is studying the reports and remains committed to working promptly with its partner Takeda and regulatory authorities to resolve this issue,” the company added. The Japanese company Takeda Pharmaceutical is engaged in the distribution of the vaccine in the country.
A spokesman for the Ministry of Health said Takeda first learned about the impurities on August 16 and reported it to the government on Wednesday. It took the company some time to collect information about which vials contained impurities and where they are located.
Moderna reported that the appearance of impurities might be due to a production problem at the plant in Spain.
The European Medicines Agency (EMA) said it is investigating the incident and assessing whether it will affect supplies to the EU.
According to EU public data, Moderna has delivered more than 70 million doses of the COVID-19 vaccine to the EU. The company has two contracts with the unit for the total supply of up to 460 million doses.
Japanese Prime Minister Yoshihide Suga assured that this problem would not greatly affect the vaccination plan in the country.
A day earlier, he said that about 60 percent of the population would be fully vaccinated by the end of September. There are enough vaccines in the country to administer booster doses.
In Japan, there is an aggravation of the epidemiological situation due to the spread of the “Delta” variant. This month, the daily number of infections exceeded 25,000 people for the first time. According to Reuters, 54 percent of the country’s population is vaccinated with at least one dose, and 43 percent – completely.