Moderna Inc., a pharmaceutical and biotechnology firm based in the United States, announced a recall for 764,900 doses of its COVID-19 vaccine Spikevax in Europe on Friday after impurities were identified in a vial.
According to a joint statement from ROVI, Moderna, and Spain’s ROVI Pharma Industrial Services, the lot is being recalled because a foreign body was discovered in one vial in the lot created at the company’s contract manufacturing location.
The pharmaceutical did not say what sort of foreign material was discovered, only that it had recalled the entire batch out of caution.
The contamination was found in only one vial of the batch, and investigators think there was no risk to the remaining vials in the lot.
No safety problems were reported in anyone who received the Moderna COVID-19 vaccination from this batch, according to a scan of Moderna’s worldwide safety database. There have been no difficulties with safety or efficacy so far.
The lots were distributed in Norway, Poland, Portugal, Spain, and Sweden from January 13 to 14. More than 900 million doses of the Moderna COVID-19 vaccine have been given out globally to far.
Last year, Japanese officials ordered Moderna to recall several batches of its COVID-19 vaccinations after an examination discovered stainless steel contamination in certain vials. The recalled batches were all made by the same business in Spain, ROVI.
Takeda Pharmaceutical, Japan’s largest pharmaceutical company, stated in a statement that the contamination was traced back to ROVI’s manufacture. The discoveries were uncovered via a joint inquiry by the two corporations, not by the Japanese Ministry of Health.
In August 2021, three men in Japan became very sick after receiving a second dosage of the now-recalled COVID-19 vaccination and died soon after. Takeda said in a statement at the time that there is no evidence they are linked to the vaccine.