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Vaccine product alert for Rabipur Rabies vaccine

03 September 2024

Reports of rubber particles after reconstitution: recommendations to minimise the risk of particles

Bavarian Nordic in agreement with the Medicines and Healthcare products Regulatory Agency (MHRA) sent a communication out to customers on 20 August 2024 following reports of rubber particles found in Rabipur rabies vaccine solution after reconstitution.

The particles have been revealed to be from the rubber stopper of the vaccine vials during the reconstitution process (known as ‘coring’).

The healthcare professional communication letter provides recommendations for UK healthcare professionals on how to minimise the risk of particles during reconstitution, which include:

  • recommendations on how to perform the reconstitution process to reduce the risk of particles caused by ‘coring’
  • carefully visually inspecting all reconstituted vaccine before administration, and discarding in the event of visible particles being identified
  • reporting any suspected adverse reactions through the MHRA Yellow Card scheme
  • manufacturer contact details for product quality complaints and/or clinical enquiries about the Rabipur vaccine

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