Vaccine Development Process Map

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



Manufacturing at scale and registration

8. 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
9. Review TPP
10. Compile dossier for submission (Essential Go/No Go step)
11. Submit dossier to regulators (e.g. VMD/EMA) B
12. Opinion issued
13. Market approval
14. Product launch

End of Process