Some 764,900 doses of the Moderna vaccine have been withdrawn by Spain’s Ministry of Health after a 'foreign body' was found inside a sealed vial, it has been confirmed by the department. The coronavirus vaccine, identified with the lot number 000190A, was also distributed to Portugal, Poland, Sweden and Norway, countries that have already alerted their respective health systems of this incident.
It was last Friday when the Spanish Agency for Medicines and Health Products (Aemps) ordered the withdrawal of the lot after detecting "the presence of a foreign body inside a vial", without going into more details, only indicating that it had been "segregated" and that it had not been administered to any patient.
However, the health alert issued by the Norwegian authorities refers to Moderna's preliminary conclusion and specifies that the foreign body was a "small insect, a mosquito, that entered the vial during production.”
For its part, Aemps stresses that the withdrawal of the batch has been adopted as a preventive measure, "since the incident has only been detected in a single unit and it is not expected that there will be more affected in the lot." The authority has confirmed that the manufacturer is already investigating to determine how it could have happened and prevent it from occurring again.
The Spanish pharmaceutical company ROVI, a partner of Moderna, has confirmed that the affected batch left its facilities in Spain and that the vial in question was "perforated but not administered". Likewise, it acknowledged that the company was alerted to the issue through a claim about the product coming "from a vaccination centre in Malaga", which later led to it being returned "for evaluation and investigation".
Moderna explained that they have carried out “a cumulative search in their global safety database” and have not found any safety problems in relation to the people who received the vaccine. Similarly, the company "does not believe that this poses a risk to other vials in the batch or that this affects the significant benefit/risk profile", and stresses that more than 900 million doses of the serum have been administered without incident throughout the world.