The Danish Medicines Agency (Lægemiddelstyrelsen) has decided to quarantine a batch of the Pfizer/BioNTech COVID-19 vaccine.
The reason is that the formation of bubbles in the vaccine has been observed at several vaccination sites in the Region of Zealand, as well as at a pharmacy in the Capital Region, after the vaccine has been drawn into the syringe.
The Danish Medicines Agency became aware of the bubbles in the vaccine on Monday.
The phenomenon of bubbles in the vaccine pertains to a specific batch of the Pfizer/BioNTech COVID-19 vaccine. This particular batch is labeled as HG2252, and approximately 57,000 doses from this batch have been used. Preliminary information suggests that it has been in use in all regions of the country.
The cause of this bubble formation is still unknown, but the Danish Medicines Agency is in close contact with Pfizer, the State Serum Institute, and the regions to promptly determine the cause and any potential implications for the vaccine’s quality and safety.
According to the Danish Medicines Agency, there are currently no signs that this specific batch has any impact on the vaccine’s effectiveness or safety. As a precautionary measure, the Danish Medicines Agency has decided to quarantine this batch of vaccine until the cause is clarified. They are working with the manufacturer to further investigate the matter.
New vaccines will be distributed as soon as possible. The State Serum Institute states that they will distribute new COVID-19 vaccines from other batches to vaccination sites across the country as quickly as possible so that citizens who have had their COVID-19 vaccination appointments canceled can be offered an alternative vaccination.
Citizens who experience the cancellation of their COVID-19 vaccination appointments can schedule a new vaccination appointment on vacciner.dk, as announced by the Danish Medicines Agency.