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SAM immediately informed the coordinator to temporarily suspend vaccination with this batch of vaccine. The State Agency for the Control of Medicines (IARC) was instructed to investigate before Wednesday night whether the vaccine had been affected by temperature fluctuations during transport. SAM provided the data to the Pfizer representative office in Lithuania for the manufacturer to conclude whether the fluctuations found did not affect the quality of the vaccine.
Conclusions from IWT and Pfizer’s representative office in Lithuania are still awaited today on whether further use of these doses of vaccine is possible. The aforementioned shipment contained 4,680 doses of COVID-19 vaccine: 2,340 doses of vaccine for the Kaunas and Panevėžys regions.
According to the preliminary assessment of the Pfizer representative office in Lithuania, the temperature drift during transport was within the allowed limits and had no effect on the vaccines.
Vaccination can be resumed
The Ministry of Health has approved the manufacturer’s approval to resume vaccination with a single batch of BioNTech and Pfizer vaccines.
Vaccination with these vaccines has been suspended because “the cold chain may have been damaged during transport.”
“Based on the stability study data provided by the manufacturer, it has been determined that the temperature deviation from the transport conditions mentioned above is within the allowable range. The above products are suitable for later use ”, SAM quotes a representative of the vaccine manufacturer.
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