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References TB Vaccine Development Pathway

Guidance and Considerations

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Guidance
The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development - ScienceDirect
WHO Preferred Product Characteristics for New Tuberculosis Vaccines

Function 1: Project Management

WHO investment case for new TB vaccines
Lee and Burke, Vaccine 2010
FDA Guidance
UK MRC guidance
BCG AJV
BCG SII
BCG GreenSignal BioPharma 
BCG Tice
WHO PPC for New TB Vaccines
PDP for a Generic Prophylactic Vaccine for Infectious Diseases

Function 2: Business/Legal/IP

WHO investment case for new TB vaccines
WHO Guidance

Function 3: Product Characterisation and Quality

ICH Quality Guidelines
Geneva consensus
The second Geneva Consensus: Recommendations for novel live TB vaccines
ICH Q8
ICH Q11
ICH Q2

Function 4: Production Process

WHO recommendations BCG vaccines, 2013
ICH Quality Guidelines
ICH Q7
ICH Q8
ICH Q11
ICH Q2
EMA guidelines on adjuvants in vaccines
Quality aspects included in the product information for vaccines for human use
Quality, non-clinical and clinical aspects of live viral vectored vaccines
Liposome Drug Products FDA Guidance
Josefsberg and Buckland 2012
Plotkin’s Vaccines
Fitzpatrick et al., 2019
Pascoe et al., 2020
Walker and Bacon, 2023

Function 5: Preclinical Safety

WHO Recommendations
WHO guidelines on non-clinical evaluation of vaccines. WHO Technical report series No927, 2005
FDA/CBER Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, 11/2007
WHO Technical Report Series No 941, 2007
FDA platform designation guidelines
EMA/CHMP/VWP/141697/2009
WHO guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, Annex 2, TRS No 987
Walker et al., 2010
Arbues et al., 2013
FDA

Function 6: Preclinical Immunogenicity

Orme and Ordway, 2016
Stylianou et al., 2018
Aagaard et al., 2011

Function 7: Preclinical Protection/Efficacy

Pozo-Ramos and Kupz, 2025
Cardona and Williams 2017
Singh and Gupta 2018
Williams and Orme 2016
Stylianou et al 2018
Doherty et al., 2004
Reed and Lobet 2005
Williams et al., 2005
Brandt et al., 2004
Clark et al., 2016
CTVD
PAX – TBVI
Medina and North, 1998
Hackett et al., 2022
NIAID/NIH pre-clinical models
TBVI

Function 8: Regulatory

A regulatory plan for TB vaccines – points to consider
EU-M4all
Regulation (EC) No. 726/2004
World Health Organization (WHO)
SAHPRA
CDSCO
AVAREF
Dellepiane et al, 2018
GAVI, the Vaccine Alliance
WHO prequalification
WHO guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, 2013
WHO Guidelines for assessing the quality, safety and safety of DNA vaccines
FDA Guidance for Industry, Considerations for plasmid DNA vaccines for infectious disease indications, Nov 2007
EMA/CHMP/VWP/141697/2009, Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines
Liposome containing vaccines: Liposome drug products, FDA Guidance for Industry, April 2018
Walker et al., 2010
EMA guidelines
Knezevic et al., 2021
US Pharmacopeia (USP)
WHO recommendations on BCG vaccines
WHO Listed Authority
WLA Framework
PBRER
ICHE2E: Guideline on Pharmacovigilance Planning
EDQM
CBER batch release
CTD
ICH M2 EWG
WHO/IVB/05.23

Function 9: Clinical Development and Operations

WHO Evidence Considerations for Vaccine Policy
Miner et al., 2022
WHO optimal and early inclusion of pregnant and lactating women
WHO ECVP
Hamada et al., 2023
Chen et al., 2025
Cobelens et al., 2025

Function 10: Clinical Safety

Miner et al., 2022

Function 12: Clinical Efficacy

Frascella et al., 2021
Stuck et al., 2024
White et al., 2025
Churchyard et al., 2024
WHO standardised case definitions
Knight et al., 2014
WHO ECVP
WHO PPC for New TB Vaccines
Rangaka et al., 2023
European AIDS Treatment Group (EATG)
Miner et al., 2022
WHO optimal and early inclusion of pregnant and lactating women
EMA
FDA

Function 13: Market, Access and Implementation

WHO global framework to prepare for country introduction of new TB vaccines for adults and adolescents
WHO PPC for New TB Vaccines
ECVP
SAGE report BCG
Formal SAGE recommendations
WHO position paper on the use of BCG from 2018
Vaccines Europe
Knight et al,. 2014
Bellini et al., 2016
An investment case for new tuberculosis vaccines
GAVI vaccine investment strategy

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First publication 2012