Tokyo, Oct 1 (EFE).- Pharma giant Moderna Friday said its anti-coronavirus vaccine vials found containing metal contaminants that led to a recall from Japan posed “no undue risk to patient safety.”
The contaminated vaccine vials were produced in Spain and were imported and distributed by Takeda Pharma in Japan,
The two firms launched a probe after some vaccine vials were found contaminated with stainless steel particles.
The controversy prompted authorities to recall 1.63 million doses of Moderna’s Covid-19 vaccine from Japan.
“The rare presence of stainless steel particles – observed in one of the recalled lots – presented no undue risk to patient safety and did not adversely affect the benefit/risk profile of the product,” the two companies said in the joint report.
The Spanish manufacturer, in charge of the production of Moderna vaccines in Europe and supplier for Japan, also took part in the probe.
The probe concluded that “the most probable cause of the particles identified in one of the recalled lots is related to friction between two pieces of metal installed in the stoppering module of the production line.”
The report said it was due to an “incorrect assembly” and a “human error specific to visually misjudging the required 1mm gap between the star-wheel and the stopper.”
The two pharma companies affirmed that “corrective actions” would help mitigate the risk of the problem reoccurring.
The corrective measures would be overseen and confirmed by Moderna in collaboration with Takeda.
The Japanese authorities earlier this week recalled 1.63 million Moderna vaccine vials as a preventive measure after foreign particles appeared in 39 vials, which is equivalent to 390 doses.
The health ministry reported that some 500,000 people had shots from the three suspended batches.
It announced three deaths of beneficiaries who received the Moderna vaccine doses.
The Japanese authorities have said they were investigating if the deaths were related to the vaccines.
“At this time, there is no evidence that the three tragic deaths following administration of the Moderna Covid-19 vaccine from Lot 2 were in any way related to the vaccine,” the two companies said in the report.
“A formal, independent investigation to confirm the cause of death in these cases is ongoing and it is being conducted by the appropriate authorities with the greatest sense of urgency, transparency and integrity.”
Moderna stressed that its vaccine “has a well-established safety and efficacy profile.”
“More than 200 million doses of the Moderna Covid-19 vaccine have been administered to more than 110 million individuals in 45 countries,” said the report.
The two firms said their “top priority” was to continue to support the Japanese health efforts to fight the ongoing pandemic and bring the vaccine to everyone to benefit from it. EFE