Finding a mosquito inside a vial of the vaccine against covid-19 of Moderna in a vaccination center in Malaga has motivated the preventive withdrawal of a batch manufactured in Spain consisting of 764,900 doses and was distributed last January in five countries.
Sources from the Ministry of Health have explained this Tuesday that the Board transferred a few days ago to the Spanish Agency for Medicines and Health Products (AEMPS) of the discovery of the mosquito in a vial of the vaccine, which was not administered, and that the batch was withdrawn “according to the process.”
The AEMPS reported last Friday that it had ordered the withdrawal of the batch of the vaccine, marketed as Spikevaxfrom Moderna -one of the five authorized against the coronavirus-, due to the presence of a foreign body inside a vial.
Moderna and Rovi also issued a statement that day announcing the withdrawal, due to the presence of “a foreign body” in a vial, of a batch of the vaccine, which consisted of 764,900 doses, and was distributed in Norway, Poland, Portugal, Spain and Sweden from January 13 to 14 this year.
The delegate of the Ministry of Health in Malaga, Carlos Bautista, has considered that the finding is an “example” that demonstrates “how well the alert system works” in Andalusia, which allows health professionals to report that they have detected an anomaly into a product, and that in this case made it possible for that batch of vaccines to be withdrawn.
“There has been no problem at all,” assured Bautista, who has stated that he is more concerned that there is a part of the population that has not been vaccinated against covid-19 and young adults who have not yet received the third dose.
According to the AEMPS, the affected vial was identified in a vaccination center, was segregated and was not administered to any patient, and the withdrawal has been adopted as preventive measureas the issue has only been detected on a single unit and it is not expected that there will be more affected units in the batch.
He recalled that the manufacture of vaccines is carried out under highly standardized and regulated conditions at the international level to minimize the risk of this type of event and, if they occur, allow their detection before they are released on the market.
However, despite these precautions and their low frequency, these events can happen given the very high number of manufactured doses, as is the case of Moderna, which has currently put on the market more than 900 million doses worldwide.
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For their part, Moderna and Rovi announced in a statement, which is published on their website, the withdrawal of a batch of the Spikevax vaccine due to the discovery of a “foreign body” in a vial, an issue to which they were alerted to through a claim about the product from a vaccination center in Malaga.
Moderna stated that no safety issues had been reported in relation to people who received Moderna’s COVID-19 vaccine from this batch, and no incidents of safety or efficacy had been identified to date.