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The Vaccines Consistency Approach Project

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Project aim

Creation of a technical platform for human and veterinary vaccines dealing with general strategies and policies to introduce the Consistency Approach in routine release activities, prioritising the replacement of compendial in vivo tests with validated alternative in vitro tests, defining minimal acceptance criteria for alternative in vitro tests, reviewing work plans and reports provided by human and veterinary vaccine task forces or groups working on test development and validation with the ultimate goal of synchronizing initiatives for 3Rs methods in safety and potency testing of vaccines in Europe.

The project is in three phases:

  1. Establishment of a technical platform involving the stakeholders from Human and Veterinary vaccine fields
  2. Organisation of workshops to define alternatives strategies
  3. Development of the selected methods. 

Project 3Rs added value and EPAA actions

Development of alternative approaches for Quality Control of vaccines necessitates early co-ordinated dialogue and collaboration between industry and other relevant stakeholders, Control Authorities and Regulatory Authorities. EPAA makes this possible by constituting a unique platform where all parties can apply their technical experience to the search and the development of alternatives to current in vivo testing. It is a genuine partnership where the Commission provides visibility, and all parties committed to alternatives provide technical know-how; EPAA can provide a new perspective on and a new impetus for the development and implementation of alternative approaches for vaccine quality and safety assessment. The technical platform project does not aim to duplicate existing structures like ECVAM and EDQM activities but to enable early collaboration in the development of alternatives.

Potential benefits of the vaccines consistency approach are very significant in terms of animal welfare (up to 15 million of animals saved a year) and refinement and in terms of better science and faster results.

Stakeholders involved

European Commission, National regulators, European Vaccines producers, observers from US, Canada and India


  • 7 April 2011 EPAA Workshop on the Application of the Three Rs and the Consistency Approach for Improved Vaccine  Quality Control (FlashReportpdf)
  • 30-31 August 2012 DTAP vaccines workshop (FlashReportpdf)
  • 8-9 October 2012 Human Rabies workshop (FlashReportpdf)
  • 5-6 November 2012 Veterinary Rabies Workshop (FlashReportpdf)
  • 19 March 2013 Clostridial Vaccines Expert workshop (FlashReportpdf)
  • 11 September 2013 Clostridial Vaccines workshop (FlashReportpdf)

Next steps

January 2014 (TBD) Joint Veterinary & Human Rabies Vaccines Workshop

Q2 2015 Vaccines Consistency Approach Conference