The Ministry of Health (Sometimes) decided to lift the measure that ordered the immobilization of a batch of vaccines bivalentes Pfizer in a preventive way, before the detection of a presumed break in the cold chain, after verifying that the technical specifications for its conservation have been met.
Through a statement, the Sometimes recalled that the General Directorate of Medicines, Supplies and Drugs (Digemid) ordered the immobilization of batch GK1316 of bivalent vaccines Pfizerin order to carry out the corresponding verifications.
It adds that this measure was adopted in response to a communication from the Internal Control Office of the National Center for the Supply of Strategic Resources (Cenares), in which it reports that as part of its concurrent control actions, said break was detected in the Cold chain.
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Faced with this report, the Sometimes indicates that, during the investigation process, Cenares presented the documentation and information from the datalogger (device that records the history of the vaccine’s temperature) which allows verifying the temperature range at which said product was stored.
In this regard, he pointed out that it has been verified that the temperature at which the vaccinesat all times, they have been within the margins established in the technical specifications by the manufacturer and holder of the sanitary registry, that is, between -60 and -70 degrees Celsius, which is why the removal of immobilization was ordered.
The Ministry of Health, through the Digemsmaintains its commitment to guarantee the quality and safety of pharmaceutical products authorized for distribution and use in our country”ends the statement.
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2023-06-08 13:10:19
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