Danish Medicines Agency releases COVID-19 vaccine batch from quarantine

On 17 October, the Danish Medicines Agency decided to quarantine a specific batch (batch HG2252) of COVID-19 vaccines from Pfizer/BioNTech.

Since then, the Danish Medicines Agency and Pfizer have worked together to review the documentation of the batch in question, based on which the agency has now decided to release said batch from quarantine.

The decision to release the batch from quarantine with immediate effect is based on investigations received from Pfizer and a risk assessment of the formation of small bubbles in the vaccine that were observed in some vaccine extractions. 

The investigation carried out by Pfizer concludes that the formation of small bubbles in the vaccine after extraction into the syringe is a phenomenon that is likely to occur when the vaccine is exposed to changes in pressure and temperature (which happens with COVID-19 vaccines).

The examination by Pfizer also shows that the phenomenon has no impact on the quality, efficacy or safety of the vaccine.

Upon reviewing the material from Pfizer, the Danish Medicines Agency assesses that there is no risk associated with injecting the vaccine in relation to the formation of small bubbles when extracting it into the syringe. 

The vaccination centres may therefore resume vaccination with batch HG2252.