Spain’s Ministry of Health recalls batch of Moderna vaccine after finding “foreign body” in vial

The Spanish Agency of Medicines and Medical Devices, linked to the Ministry of Health, has recalled a batch of the Moderna vaccine due to the “presence of a foreign body” in a vial.

According to the Spanish Agency of Medicines and Medical Devices (AEMPS) in an informative statement released on April 8, the batch of the Moderna covid-19 vaccine to be recalled is 000190A, which has an expiry date of July 1 this year and had been manufactured by Laboratorios ROVI at their plant in Madrid.

According to AEMPS, the vial containing the “foreign body” was identified at a vaccination centre, was separated from the other vials and was not administered to any patients. They also said that there is no risk to patients who have received a dose from the batch and it is not necessary for them to take any special measures.

“This withdrawal has been adopted as a precautionary measure, as the issue has only been detected in a single vial, and it is thought that there are no more affected vials in the batch. The manufacturer is investigating to determine the cause of the problem and to prevent it from happening again. AEMPS has already carried out inspections at the manufacturing plant to verify that the control measures in place are adequate and to ensure the investigation’s proper conduct,” said the AEMPS statement.

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