The European Medicines Agency (EMA) instructed its plant in Spain on Friday to continue producing Moderna’s COVID-19 vaccine after about 1.63 million doses were suspended due to reports of contamination.
Earlier this week, Japan’s Ministry of Health, Labor and Welfare said it had received information that “foreign substances” were found in at least 390 doses (or 39 vials) of Moderna vaccine from multiple vaccination sites. Asahi Shimbun..
A US-based pharmaceutical company said the pollution could be due to manufacturing problems on one of the production lines at a Spanish consignment manufacturing site operated by Madrid-based Rovi.
“After a preliminary risk assessment of the information received so far, Rovi’s production of the COVID-19 vaccine can continue,” EMA told news agency Reuters in a Friday statement, calling for a suspension. He said he couldn’t find a reason. Production after initial evaluation.
“Investigation of the root cause is underway. As the investigation progresses, the EMA will be able to provide more information,” he added.
A Rovi spokesman who is bottling Moderna vaccines for markets outside the United States said he couldn’t say anything more while the contracted drug company was investigating the case.
Takeda Pharmaceutical Company, a Japanese pharmaceutical company that sells Moderna vaccines in Japan, has received a pollution report.
Initially, one batch of doses totaling 565,400 was discovered and withheld. Two more batches were found later and are under investigation. The Japanese Ministry of Health has requested distribution centers not to use 1.63 million doses of vaccine at all. Vaccines have been shipped to more than 800 centers nationwide.
Modena confirmed in a statement that it had begun the investigation after being notified by Takeda and explained that it was working “quickly” with Japanese companies to report. Moderna described it as a “particulate matter” that did not cause safety or efficacy issues.
Authorities said an unknown number of doses were administered from the affected lots, but no adverse effects have been reported so far. Takeda issued three batch numbers in a statement: 3004667, 3004734, and 3004956.
It is unknown whether this issue affected the supply of Moderna vaccine to other countries.
Mimi Nguyen Ly and Reuters contributed to this report.
from NTD News