U.S. biotech firm, Moderna Inc. has recently halted the supply of approximately 1.63 million doses of its COVID-19 vaccine in Japan following an allegation of potential contamination of vials, which the company believes originated from a production line in Spain.
While Moderna claims that there are no safety or efficacy concerns, the incurred delay in supply is a new setback for the company, whose partners had already demonstrated production delays last month, disrupting delivery to nations such as South Korea.
Moderna confirms that it has been alerted of incidences on this particulate matter found with its COVID-19 vaccine drug vials. The company is examining the concerns thoroughly and remains dedicated to working with its Japanese pharmaceutical partner, Takeda, and regulators to address this issue.
According to Moderna, the contamination could be the result of a manufacturing failure on one of its production lines at its contract manufacturing facility in Spain. However, It was unclear whether the problem affected exports to other countries.
The lot for which the complaint was issued had 565,400 COVID-19 vaccine doses, and as per Moderna, out of an abundance of caution, it had to put the lot, as well as two neighboring ones, on hold. In addition, Takeda stated it conducted an emergency assessment after the matter was discovered in many vaccine vials at a Japanese inoculation site.
After consulting with Takeda, Japan's health ministry announced that it had chosen to remove some dosages as a precaution but would seek to minimize the impact on its immunization plans.
Prime Minister Yoshihide Suga said that around 60% of the Japanese population would have been properly vaccinated by the end of September. The country has enough vaccines to administer booster doses if such a decision was made.