Vaccine Development Process Map

Clinical Development - List view

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

Clinical Development

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

    (A to E  ongoing until after Phase 1 clinical trial – Step 6 below)

  3. Review TPP
  4. Clinical study design
  5. Required at this stage -
    1. Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
    2. Vaccines classified as GMOs (Essential Go/No Go step) B
  6. Phase 1 clinical trial
    1. International trial?
      1. Availability of trial sites B
      2. NRA Approval (Essential Go/No Go step)B
    2. Results assessment
    3. Safety/ immunogenicity data
  7. Lead indication confirmed
    1. Vaccine safety testing – Safety reporting 
    2. Regulatory and ethics engagement – Seek advice and approvals
    3. Manufacturing – Manufacturing scale-up
      1. Fill/Finish B
    4. Commercial considerations – Input from commercial
    5. Comparability of Assay results – Immunogenicity assays

    (A to E  ongoing until Scientific advice – Step 14 below)

    Manufacturing at scale

  8. Review TPP
  9. Clinical study design
  10. Required at this stage -
    1. Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
    2. Vaccines classified as GMOs (Essential Go/No Go step) B
  11. Phase II clinical trial
    1. Commercial Licensure )based on MHRA/EAMS) – PIM designation awarded
    2. Commercial Licensure )based on MHRA/EAMS) – Scientific review for EAMS based on Phase III data
    3. Commercial Licensure )based on MHRA/EAMS) – MHRA opinion issued
    4. Commercial Licensure )based on MHRA/EAMS) – Prescribing possible prior to EMA opinion

    (A to D  ongoing in parallel with Steps  9 to 18 until Market access application begins  – Step 18 below)

  12. Scientific advice (Regulatory and HTA)
  13. Full clinical development decision (Essential Go/No Go step)
  14. Ongoing from this point –
    1. Vaccine safety testing – Prepare safety documents 
    2. Regulatory and ethics engagement – Seek scientific/regulatory advice
    3. Manufacturing – Process validation
    4. Commercial considerations – Commercial development
    5. Comparability of Assay results – Immunogenicity assays

    (A to E  ongoing until after Phase III clinical trial – Step 16 below)

  15. Review TPP
  16. Clinical study design
  17. Required at this stage -
    1. Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
    2. Vaccines classified as GMOs (Essential Go/No Go step) B
  18. Phase III clinical trial
  19. Compile and publish Dossier for submission
  20. Market access application begins

End of Process