Moderna, Inc., developer of the experimental messenger RNA (mRNA) mRNA-1273, or “Spikevax,” biologic, has recalled 764,900 doses in lot #000190A of the product from the European market. On Apr. 8, 2022, the company said that the doses, manufactured under contract to Moderna by Spanish pharmaceutical company ROVI Pharma Industrial Services, SAU, are being pulled out of “an abundance of caution” due to discovery of a “foreign substance” in a vial in Málaga, Spain.1 2 3 4 5
Lot #000190A was distributed in Norway, Poland, Portugal, Spain and Sweden during Jan. 13-14. In a press release, Moderna said it did not believe that the contamination “poses a risk to other vials in the lot” and does not believe that it “affects the significant benefit/risk profile of the vaccine.”1 2 3 4 5
While Moderna did not reveal the exact nature of the contamination, it said that the tainted vial has been submitted for “forensic assessment and investigation” and that it was “committed to working transparently and expeditiously with regulators to address any potential concerns.”1 2 3 4 5
Stainless Steel Particles Found in Spikevax
This is not the first time Moderna has experienced a contamination problem involving Spikevax. In August 2021, the company confirmed that it had received several complaints of “particular matter” in doses of the shot in Japan. On Sept. 1, the Takeda recalled 1.63 million doses (in 163,000 vials) of the product after three lots, produced by ROVI, were found to be contaminated with 316L stainless steel particles. The company said that the steel particle contamination was caused by “friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect set-up.”1 6 7 8 9
Both Moderna and the distributor of Spikevax in Japan, Takeda Pharmaceutical Co., assured the public that it did not believe the contamination of its product posed a safety problem.6 7 8 9 In a joint statement to the public, Moderna and 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… Metallic particles of this size injected into a muscle may result in a local reaction, but are unlikely to result in other adverse reactions beyond the local site of the injection.6
Three Men Die Days After Getting Second Dose of Spikevax
Later in September 2021, however, there were media reports of three individuals in Japan who had died shortly after receiving Spikevax, including a 49-year-old man who died the day after getting a second shot on Aug. 11. Two other men, 38 and 30 years old, also died in August within days after getting second doses of Spikevax.10 11 12 In another joint statement, Moderna and Takeda said:
There is no indication that any of the deaths following administration of the Moderna COVID-19 vaccine were in any way related to administration of the vaccine. Tthere is also no reason to believe the vaccine poses any health hazard or undue safety risk. This is a tragic event, and the loss of life is something that we take very seriously. We offer our sincerest condolences to their loved ones.10 11 12
In an investigative report made public on Oct. 1, 2021, Moderna and Takeda concluded that “human error” was responsible for incorrect assembly of the stopper module. The error was “specific to visually misjudging the precise 1 mm gap between the star-wheel and the stopper.”9 13
Despite the recent production problem with Spikevax in Europe, the product continues to be distributed and used in the United States. The latest recall applies only in Europe.14
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2 Mitra A. Moderna recalls over 760K COVID-19 vaccine doses in Europe. Seeking Alpha Apr. 8, 2022.
3 Moderna. Moderna Recall Notification of Lot #000190A.
4 Reuters. Moderna recalls thousands of COVID vaccine doses in Europe. Apr. 8, 2022.
5 Rovi Pharma Industrial Services. Moderna and ROVI Pharma Industrial Services, S.A.U. today announced a recall of one lot (lot #000190A) of the Moderna COVID-19 vaccine (Spikevax®). Apr. 8, 2022.
6 GlobalData Healthcare. Japan: 1.6 million Moderna vaccine doses recalled; Novavax replacement deal signed. Pharmaceutical Technology Sept. 30, 2021.
7 Inada M. Moderna Says Covid-19 Vaccine Contaminant in Japan Was Stainless Steel, Sees No Safety Issue. The Wall Street Journal Sept. 2, 2021.
8 Reuters. Moderna to recall COVID-19 doses in Japan over stainless steel contaminants. The Japan Times Sept. 2, 2021.
9 Dunleavy K. Moderna report says ‘human error’ to blame for contamination found in 3 vaccine lots from Rovi plant. Fierce Pharma Oct. 1, 2021.
10 Blair G. Third person dies in Japan after taking contaminated Moderna coronavirus vaccine. The Guardian Sept. 7, 2021.
11 Cole B. Third Person Dies After Receiving Contaminated Moderna Vaccine. Newsweek Sept. 7, 2021.
12 Sharma S. Japan says third man has died after taking contaminated Moderna vaccine. Independent Sept. 8, 2021.
13 Takeda.com. Moderna COVID-19 Vaccine Recall Investigation Report – October 2021
14 Loe M. No, the Moderna COVID-19 vaccine wasn’t recalled in the US. 11 Alive Apr. 13, 2022.