Vaccine Development Process Maps

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