Vaccine Development Process Map

Home Discovery/Feasibility List view Early-Phase Development List view Late-Phase Development and Registration List view

Veterinary Vaccine: Late-phase Development and Registration

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

Clinical Field Trials

  1. Lead(s) products
  2. Go/No go decision to enter conduct field trials (Essential Go/No Go step)
    1. Vaccine safety testing – Safety management planning
    2. Regulatory and ethics engagement – Seek advice and approvals
    3. Manufacturing development – Manufacturing scale up and consistency batches
    4. Commercial considerations – Initial commercial assumptions
    5. Comparability of Assay results – Immunogenicity assays

    (A to E  ongoing until after Field trials – Step 6 below)

  3. Review TPP
  4. Field study design
  5. Required at this stage -
    1. Ethical and regulatory approval (Essential Go/No Go step) B
    2. Vaccines classified as GMOs (Essential Go/No Go step) B
  6. Field trials
    1. International trial?
      1. Availability of trial sites B
      2. Field trial (ATC) Approval (Essential Go/No Go step)B  
    2. Results assessment
    3. Safety/ immunogenicity data
  7. Lead indication confirmed

  8. Manufacturing at scale and registration

  9. Ongoing  through steps 9 to 10
    1. Vaccine safety testing – Prepare safety documents 
    2. Regulatory and ethics engagement – Seek scientific/regulatory advice
    3. Manufacturing development – Prepare quality documents and process validation
    4. Commercial considerations – Commercial development
    5. Comparability of Assay results – Prepare efficiency documents
  10. Review TPP
  11. Compile dossier for submission (Essential Go/No Go step)
  12. Submit dossier to regulators (e.g. VMD/EMA) B
  13. Opinion issued
  14. Market approval
  15. Product launch

End of Process