A rather disturbing discovery. Moderna’s lab had to issue a recall of 764,900 doses of coronavirus vaccine. The reason for this precautionary measure? The discovery of a mosquito inside a vial in a vaccination center in Malaga, Spain, as reported by the Iberian newspaper El País.
The withdrawal was announced last Friday by the Spanish Agency for Medicines and Health Products (AEMPS), which referred to a “foreign body” in a bottle, without giving further details on the incident. The batch was produced in a Spanish factory, still according to our colleagues, located in San Sebastián de los Reyes, near Madrid. This is where the bottles are filled and packaged, while the container is produced in Switzerland.
The vials were then distributed in several countries (Norway, Sweden, Poland, Portugal and therefore Spain), all affected by the recall. It would have been shipped during the month of January. It was the Norwegian authorities who revealed the reason for this recall.
Already an incident on a batch manufactured in Spain in August
“Moderna’s preliminary conclusion is that the foreign body is a small insect, a mosquito, which entered the vial during production and was not detected by control operations,” write the Norwegian authorities.
The manufacturing company, however, wanted, in a joint press release with Moderna, to reassure. “The impacted vial was punctured and was not administered (…) The vial was returned for forensic expertise and an investigation was opened (…) No safety issues were reported in people having received the Moderna vaccine”, they write, recalling that “900 million doses of this vaccine have been inoculated in the world”.
This is the second incident related to Moderna vaccines packaged in Spain. In late August, impurities were discovered in batches of Moderna’s Covid vaccine. Investigations revealed that the impurities found were stainless steel particles caused by “friction between two metal parts installed in the cap module of the production line due to incorrect assembly”.
Japan had suspended the use of vaccines from three batches, representing more than 1.6 million doses, after reports of several vaccination centers having discovered foreign bodies in vaccine vials. The Japanese Ministry of Health had also announced last week the opening of an investigation to determine the cause of death in August of two men who received a dose of vaccine from one of the three suspended batches. According to the press release from the two companies, “there is no evidence” that these two deaths are linked to the administration of the vaccine.