In relation to the relevant information published in recent days on the recall of batches of Moderna’s Covid-19 vaccine because of the detection of particles in some vials distributed in Japan, ROVI reports the conclusions of the investigation carried out in collaboration with the Japanese Ministry of Health, Labour and Welfare, the vaccine’s proprietary laboratory, Moderna, and the authorised distributor in Japan, Takeda.
On 26 August 2021, three batches of Moderna’s Covid-19 vaccine (batch 3004667, 3004734 and 3004956) were recalled following the discovery of foreign particles in unused vials of batch 3004667.
According to the cause investigation report conducted by ROVI, the most likely cause of the particulates identified in that batch is related to friction between two metal parts installed in the capping module of the production line due to an incorrect configuration during a line changeover prior to the start of production of batch 3004667.
According to ROVI’s analysis, the manufacturing incident only affected the three batches that were suspended and for which Takeda has requested a definitive recall.
ROVI, in coordination and in agreement with Moderna, has taken the appropriate measures to strengthen the processing and control protocols with the process requirements that have been revealed in relation to these new manufacturing activities in order to prevent potential incidents.
From ROVI’s Management we would like to send a message of thanks to the teams involved in the investigation of what happened, who have worked over the last few days with the utmost sense of urgency and displaying their professionalism and commitment.
Likewise, we convey our full support to these professionals who continue to work and offer solutions to ensure that our activity continues as normal.
Particulate analysis and safety assessment
According to the independent analysis carried out by Moderna, the particulate from batch 3004667 has been thoroughly analysed and is confirmed to be 316 grade stainless steel. This is consistent with the determination of the particle origin described above. Grade 316 is a high grade of stainless steel commonly used in the manufacture and processing of stainless steel in food manufacturing and processing
Following a health assessment conducted by Moderna and Takeda, the rare presence of stainless steel particles in Moderna’s COVID-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the benefit/risk profile of the product.
Metal particles of this size injected into a muscle may cause a local reaction, but are unlikely to cause other adverse reactions beyond the injection site. Stainless steel is commonly used in heart valves, joint replacements and metal sutures and staples. Therefore, injection of the particles identified in these batches in Japan is not expected to pose any major medical risk.
Investigation into two deaths following vaccine administration
As reported by Moderna and Takeda in their press release, there is currently no evidence that the two tragic deaths that occurred following the administration of Moderna’s Covid-19 vaccine (from lot 3004734) were related to the administration of the vaccine. The link is now considered to be coincidental. However, both companies are conducting an investigation with the utmost sense of urgency to provide conclusions.
