Moderna and Rovi Pharma recall 764,900 COVID-19 Vaccine doses in EU due to Contamination.
Last year, Japanese officials ordered Moderna to recall multiple batches of its COVID-19 vaccinations after an examination discovered stainless steel contamination in certain vials. Again, now Moderna recalls 764,900 COVID-19 vaccine doses after a contamination was found.
Moderna Inc., a pharmaceutical and biotechnology firm based in the United States, initiated a withdrawal for 764,900 dosages of its COVID-19 vaccine “Spikevax” in Europe on Friday after contaminants were identified in a vial.
Across a joint statement (read below), Moderna and Spain’s ROVI Pharma Industrial Services reported that “the lot is being recalled due to a foreign body being found in one vial in the lot manufactured at the company’s contract manufacturing site, ROVI.”
The pharmaceutical did not say exactly what sort extraneous substance was discovered, but said the entire batch had been withdrawn out of “an abundance of caution.”
The contamination was found in only one vial of the lot, and experts assess there was no danger to the remaining vials in the batch.
“Moderna conducted a cumulative search of its global safety database, and no safety concerns were reported in individuals who received the Moderna COVID-19 vaccine from this lot. To date, no safety or efficacy issues have been identified,” according to the statement.
The lots were dispersed in Norway, Poland, Portugal, Spain, and Sweden from January 13 to 14. Upwards of 900 million dosages of the Moderna COVID-19 vaccine have been given out globally to date.
Last year, Japanese officials ordered Moderna to recall multiple batches of its COVID-19 vaccinations after an examination discovered stainless steel contamination in certain vials. The recovered batches were all made by the same business in Spain, ROVI.
Takeda Pharmaceutical, Japan’s largest drugmaker, said during a statement that the contamination was traced all the way back to ROVI’s manufacturing. The discoveries were uncovered by a joint inquiry by the two corporations, not by the Japanese Ministry of Health.
In August 2021, three men in Japan became very ill after receiving a second dosage of the now-recalled COVID-19 vaccination and tragically died afterwards. According to Reuters, Takeda claimed in a statement at the time that there is no proof they are connected to the vaccine.
“Stainless steel is routinely used in heart valves, joint replacements, and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” the company said.
Two males, ages 30 and 38, were the very first two people in the country to die as a result of tainted Moderna dosages. They perished two days after receiving a second dose of vaccination from a faulty batch.
The third case was a 49-year-old male who became ill after obtaining his second dose and died the very next day, according to the health ministry. His only recorded medical condition was a buckwheat allergy.