A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. The withdrawal takes place because of a small increase in non-serious side effects, mainly hypersensitivity reactions, from one batch of Preflucel.
14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market. There have been no reports of side effects in Denmark.
As a safety precaution, Baxter A/S, in collaboration with the Danish Medicines Agency, has decided to withdraw the batch concerned: VNV5L010.
There are no other Preflucel batches on the Danish market.
There are alternative influenza vaccines on the Danish market, and no supply difficulties are therefore expected.
While the cause of the small increase in the number of side effects is being investigated, other batches of Preflucel intended for the Danish market will be retained.
Therefore, there is no cause for concern about influenza vaccination in Denmark.
