Covid-19 vaccine batch in quarantine
As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question.
Monday evening, the Danish Medicines Agency was made aware that the staff at a number of vaccination centres in Region Zealand and a pharmacy in the Capital Region of Denmark had observed the presence of bubbles in the vaccines after drawing the vaccine into the syringe. The phenomenon of bubbles in the vaccine concerns a specific COVID-19 vaccine batch from Pfizer/BioNTech. The number of the concerned batch is HG2252. Approximately 57,000 doses of this batch have been used, and the information so far suggests that the batch has been used in all Danish regions.
It is not yet known what causes the bubbles in the vaccine, but the Danish Medicines Agency is in close contact with Pfizer, Statens Serum Institut (SSI) and the Danish regions to quickly find the cause and determine if there are any consequences for the quality and safety of the vaccine.
At present, there are no signs of any impact on the efficacy and safety of the batch in question.
As a precautionary measure, the Danish Medicines Agency has decided to quarantine this batch until it is clear what the cause is. We and the manufacturer have started investigating the matter, and as soon as we know more about the cause and any consequences, we will report it here on the website.
We kindly ask you to contact your vaccination centre if you have any questions in this connection.
The general public may always contact their own doctor if they experience any unexpected side effects after vaccination.
New vaccines will be distributed as soon as possible
The SSI will promptly distribute additional COVID-19 vaccines from other batches to vaccination centres across Denmark to ensure that people whose vaccination appointments were cancelled are offered vaccination.
People whose COVID-19 vaccine appointments were cancelled, may schedule a new appointment at vacciner.dk.