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CVMP Assessment Report for Innovax-ND-IBD to Add a New Route

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CVMP Assessment Report for Innovax-ND-IBD to Add a New Route 21 March 2019 EMA/193705/2019 Veterinary Medicines Division Committee for Medicinal Products for Veterinary Use CVMP assessment report for Innovax-ND-IBD to add a new route of administration (in ovo) for chicken embryonated eggs (EMEA/V/C/004422/X/0001) Vaccine common name: Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant) Assessment report as adopted by the CVMP with all information of a commercially confidential nature deleted Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Introduction ................................................................................................ 4 Marketing authorisation under exceptional circumstances ................................................ 4 Scientific advice .......................................................................................................... 4 MUMS/limited market status ........................................................................................ 4 Part 1 - Administrative particulars .............................................................. 4 Detailed description of the pharmacovigilance system ..................................................... 4 Manufacturing authorisations and inspection status ......................................................... 5 Overall conclusions on administrative particulars ............................................................ 5 Part 2 – Quality ........................................................................................... 5 Chemical, pharmaceutical and biological/microbiological information (quality) .................... 5 Qualitative and quantitative particulars of the constituents............................................... 5 Qualitative and quantitative particulars .......................................................................... 5 Containers and closures ............................................................................................... 6 Product development ................................................................................................... 6 Description of the manufacturing method....................................................................... 6 Production and control of starting materials ................................................................... 7 Starting materials listed in pharmacopoeias ................................................................... 7 Specific materials not listed in a pharmacopoeia ............................................................. 7 Starting materials of biological origin ............................................................................. 7 Starting materials of non-biological origin ...................................................................... 8 In-house preparation of media and solutions consisting of several components .................. 8 Control tests during the manufacturing process .............................................................. 8 Control tests on the finished product ............................................................................. 8 Batch-to-batch consistency .......................................................................................... 9 Stability ..................................................................................................................... 9 Overall conclusions on quality ..................................................................................... 10 Part 3 – Safety .......................................................................................... 10 Introduction and general requirements ........................................................................ 10 Safety documentation ............................................................................................... 11 Laboratory tests ....................................................................................................... 12 Safety of the administration of one dose ...................................................................... 12 Safety of one administration of an overdose ................................................................. 12 Safety of the repeated administration of one dose ........................................................ 13 Examination of reproductive performance .................................................................... 13 Examination of immunological functions ...................................................................... 13 Special requirements for live vaccines ......................................................................... 14 Spread of the vaccine strain ....................................................................................... 14 Dissemination in the vaccinated animal ....................................................................... 15 Reversion to virulence of attenuated vaccines .............................................................. 15 Biological properties of the vaccine strain..................................................................... 15 Recombination or genomic re-assortment of the strains ................................................. 15 CVMP assessment report for Innovax-ND-IBD to add a new route of administration (in ovo) for chicken embryonated eggs (EMEA/V/C/004422/X/0001) EMA/193705/2019 Page 2/40 User safety .............................................................................................................. 16 MRLs ....................................................................................................................... 16 Withdrawal period ..................................................................................................... 16 Interactions ............................................................................................................. 16 Field studies ............................................................................................................. 17 Environmental risk assessment ................................................................................... 19 Considerations for the environmental risk assessment ................................................... 19 Environmental risk assessment for products containing or consisting of genetically modified organisms ................................................................................................................ 19 Overall conclusions on the safety documentation .......................................................... 20 Part 4 – Efficacy ........................................................................................ 21 Introduction and general requirements ........................................................................ 21 Challenge model: ...................................................................................................... 21 Efficacy parameters and tests: ................................................................................... 21 Efficacy documentation .............................................................................................. 21 Laboratory trials ....................................................................................................... 23 Dose determination ................................................................................................... 23 Onset of immunity .................................................................................................... 23 Duration of immunity ................................................................................................ 29 Maternally derived antibodies (MDA) ........................................................................... 31 Interactions ............................................................................................................. 32 Field trials ................................................................................................................ 36 Overall conclusion on efficacy ..................................................................................... 37 Part 5 – Benefit-risk assessment ............................................................... 38 Introduction ............................................................................................................. 38 Benefit assessment ................................................................................................... 39 Direct therapeutic benefit .......................................................................................... 39 Additional benefits .................................................................................................... 39 Risk assessment ....................................................................................................... 39 Risk management or mitigation measures .................................................................... 40 Evaluation of the benefit-risk balance .......................................................................... 40 Conclusion ............................................................................................................... 40 CVMP assessment report for Innovax-ND-IBD to add a new route of administration (in
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