Three lots of Moderna's COVID-19 vaccine — lot numbers 3004667, 3004734 and 3004956 — were suspended following reports from vaccination sites of a potential foreign particulate substance observed in unused vials from lot 3004667.
What Happened: Following a root cause analysis, Moderna said it concluded a manufacturing issue stemming from friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect setup was responsible for the contamination.
"It is believed that this condition occurred during the assembling of the line prior to production of batch 3004667 and was a result of improper alignment during a line changeover before starting this batch," the company said.
The unearthing of the issue followed analysis done by Moderna in conjunction with contract manufacturer Rovi, its Japanese authorized distributor Takeda Pharmaceutical Company Limited (NYSE:TAK) and Japan's Health Ministry.
Moderna's independent analysis also showed the particle found in lot 3004667 was confirmed as grade 316 stainless steel, consistent with the root cause analysis.
The company, along with Takeda, said "the rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product."
Moderna also said two deaths following administration of its COVID-19 vaccine from lot 3004734 were in no way related to administration of the vaccine.
Moderna Initiates Remedial Steps: Citing analysis conducted by Rovi, Moderna said the manufacturing issue only impacted the lots that were included in the suspension.
The company also said its contract manufacturer Rovi has taken steps to avoid future defects that include full inspection of the manufacturing line, improving the standard operating procedure for changeover of manufacturing line and setting alert inspection limits in the automatic visual inspection as an internal process control.
Takeda is planning to initiate the recall of the three suspended lots from the market as of Sept. 2, and Moderna is in full agreement with the decision, the U.S. vaccine maker said.
At last check, Moderna shares were up 0.89% at $380.04.