2025 vaccine research and development priorities report

Introduction

In 2015, the Public Health Agency of Canada (PHAC) identified a set of priority pathogens and diseases for vaccine research and development (R&D) (Government of Canada Web Archive). An update to these priorities was needed to reflect the substantial technological advances and changes to the public health and infectious disease landscapes that occurred over the past decade.

The 2025 Vaccine R&D Report focuses on preventative vaccines for human pathogens that cause infectious disease regularly in Canada and are considered to have a high public health burden. This work is complementary to, but distinct from, other exercises that prioritize pathogens of epidemic or pandemic concern. The 2025 Vaccine R&D report encompasses a ten-year time horizon and is divided into the following three sections:

Section 1: List of pathogens ranked as high, medium, or low priority for vaccine R&D
Section 2: Outline of broader vaccine R&D perspectives for consideration by Canada's research community and vaccine industry when developing vaccine candidates
Section 3: State of the vaccine development pathway for each listed pathogen at the time of report completion (July 2025)

The 2025 Vaccine R&D Priorities Report may be of particular use to academic institutions, funders of R&D projects for vaccines, and the vaccine industry. Canadian provinces and territories may also use this report to inform early discussion about potential changes to their own vaccination programs.

Please note that listing of a disease or pathogen in this report does not indicate a commitment from the Canadian government to fund R&D programs for these priority vaccine targets, nor does it commit the Canadian government to purchase any vaccines that may arise from such research.

Stakeholders and expert groups that contributed to the initial development of this work include the following (contribution does not mean endorsement):

Vaccine R&D Internal Working Group
Canadian Immunization Committee (CIC)
Communicable and Infectious Disease Steering Committee (CIDSC)
Indigenous Services Canada VPD Working Group (ISC VPD WG)
Federal departments and agencies with an interest in vaccines and disease surveillance

Pathogens prioritized for vaccine research and development

Process used to establish ranked vaccine R&D priorities list

A set of vaccine R&D priorities were developed using a multi-stage process involving publicly-available information and consultation with subject matter experts (SMEs) across Canada with knowledge on infectious diseases, public health, surveillance, epidemiology, and vaccine research.

First, a long-list of potential pathogens was identified from existing reportable disease lists and relevant prioritization exercises. The long-list was refined using specific exclusion criteria based on current vaccine status, endemicity, and clinical considerations.
Next, the remaining pathogens were ranked as high, medium, or low priority for vaccine R&D using weighted pathogen-specific evidence collected for key infectious disease criteria.
Finally, SMEs from across Canada were invited to participate in a modified Delphi process intended to seek consensus on included pathogens and relative ranking.

Table 1. Vaccine research and development priorities in Canada, 2025^{Table 1 Footnote a}
Priority ranking	Vaccine-preventable diseases (pathogens)
High	Clostridioides difficile Gonorrhea (Neisseria gonorrhoeae) Group A streptococcus (Streptococcus pyogenes) Haemophilus influenzae, non-type b^{Table 1 Footnote b} Influenza (due to identified seasonal influenza viruses)^{Table 1 Footnote c} Staphylococcus aureus (MRSA, VISA, VRSA) Syphilis (Treponema pallidum) Tuberculosis (Mycobacterium tuberculosis)^{Table 1 Footnote c}^{Table 1 Footnote d}
Medium	Chlamydia (Chlamydia trachomatis) Hepatitis C Herpes simplex virus 2 Lyme disease (Borrelia burgdorferi) Pertussis (Bordetella pertussis)^{Table 1 Footnote c}   COVID-19 (SARS-CoV-2)^{Table 1 Footnote c} Vancomycin-resistant Enterococci (VRE)
Low	Anaplasmosis (Anaplasma phagocytophilum) Babesiosis (Babesia species) Cytomegalovirus (CMV) Escherichia coli (STEC, ETEC^{Table 1 Footnote c}^{Table 1 Footnote e}) Group B streptococcal disease (Streptococcus agalactiae) Helicobacter pylori Norovirus Rabies (Lyssavirus rabies)^{Table 1 Footnote c} West Nile virus
Unranked^{Table 1 Footnote f} (direction ranking leaning towards)	Human immunodeficiency virus (HIV) (Medium-High) Klebsiella pneumoniae (No clear ranking) Pseudomonas aeruginosa (Medium)
Undetermined^{Table 1 Footnote g} (direction inclusion leaning towards)	Human metapneumovirus (include) Mpox^{Table 1 Footnote c} (include)
Acronyms ETEC: Enterotoxigenic Escherichia coli MRSA: Methicillin-resistant Staphylococcus aureus STEC: Shiga toxin-producing Escherichia coli VISA: Vancomycin-Intermediate Staphylococcus aureus VRSA: Vancomycin-resistant Staphylococcus aureus Table 1 Footnote a Pathogens were eligible for inclusion if there is no authorized vaccine in Canada, as well as if there is a vaccine but a more effective vaccine could be authorized for public health benefit. Pathogens are not ordered within ranking categories. Nomenclature reflects naming conventions used in the original source lists. In situations where one source referred to the disease and another to a specific pathogen, they were combined and formatted the entry as 'Disease (pathogen)'. Return to footnote a referrer Table 1 Footnote b Haemophilus influenzae non-b refers to invasive disease caused by serotypes a, c, d, e, f, undifferentiated, or non-typeable isolates. Return to footnote b referrer Table 1 Footnote c This pathogen/disease currently has at least one authorized vaccine in Canada. Return to footnote c referrer Table 1 Footnote d The BCG vaccine, though authorized by Health Canada, is not recommended for routine use in tuberculosis prevention in Canada. It is part of the publicly-funded childhood vaccination program only in the Northwest Territories and Nunavut. In other parts of Canada, it is also used for tuberculosis prevention in infants in high-risk communities. Bacille Calmette-Guérin (BCG) vaccine: Canadian Immunization Guide Return to footnote d referrer Table 1 Footnote e DUKORAL^® is authorized in Canada for the prevention and protection of cholera and ETEC travellers' diarrhea. The vaccine does not contain E. coli bacterial components but contains a cholera toxin that is similar to the ETEC-produced heat-labile enterotoxin (LT). Protection against ETEC strains not producing LT has not been demonstrated (DUKORAL^® Product Monograph). STEC does not have an authorized and licensed vaccine in Canada. Return to footnote e referrer Table 1 Footnote f Delphi participants reached consensus about the inclusion of these pathogens for vaccine R&D, but did not reach consensus on their priority ranking. The direction Delphi participants were leaning towards is indicated in brackets. Return to footnote f referrer Table 1 Footnote g While Delphi participants suggested these pathogens for inclusion as priorities for vaccine R&D, they did not reach consensus on inclusion or ranking by the end of the Delphi process. The direction Delphi participants were leaning towards with regard to inclusion is indicated in brackets. Return to footnote g referrer

Broader vaccine research and development perspectives

Table 2 outlines some of the broader intersecting factors impacting the vaccine development lifecycle that may be important considerations when developing vaccine candidates.

Table 2. Potential impacts on vaccine research and development
Theme	Potential impacts
Novel technologies	Innovations in novel vaccine platforms, delivery methods, and immune modulators (adjuvants), have the potential to expand the reach and impact of vaccines across a broader range of infectious diseases.
Artificial intelligence (AI)	AI has the potential to be integrated at various stages of the vaccine R&D process as a complimentary resource/strategy to address historically challenging aspects of vaccine development.
Climate change	For some climate-sensitive pathogens, climate change can lead to changes in geographic ranges of vectors, longer replication seasons, greater activity, and invasion of new vectors, potentially resulting in increasing number of cases and emergence of new pathogens.
Antimicrobial resistance	Vaccination is increasingly being viewed as a critical tool in mitigating the development of antimicrobial resistance. As a form of infection prevention, vaccination may subsequently lead to reduced antimicrobial prescribing. Vaccination against bacteria at risk for antimicrobial resistance may lower the rates of these infections, thereby lowering reliance on antibiotics for treatment. Vaccination against viruses may reduce the inappropriate use of antibiotics for certain viral infections. Preventing viral infections may also reduce the development and transmission of secondary or opportunistic bacterial infections, thereby reducing the need for antibiotics.
Pathogens of pandemic and/or emergency potential^{Table 2 Footnote a}	Climate change, antimicrobial resistance, and increased globalization are expected to continue to drive the emergence of pathogens with epidemic and pandemic potential. Research focused on pathogen identification and characterization, epidemiological modelling, therapeutic discovery and vaccine design is foundational for rapidly developing and deploying vaccines against emerging pathogens with pandemic potential that can be made available, safe, effective and affordable.
Health Equity	Health equity influences every stage of the vaccine R&D lifecycle, from disease surveillance and clinical trial participation to vaccine implementation. Ensuring equitable inclusion and consideration across diverse populations is essential for understanding disease patterns, evaluating vaccine safety and impact, and developing guidance and strategies that meet the needs of all groups.
Table 2 Footnote a Especially relevant for strategic policy alignment across sectors, departments, organizations, and jurisdictions Return to table 2 footnote a referrer

Vaccine development status for pathogens in Table 1

To provide an overview of the vaccine landscape and highlight where additional vaccine R&D efforts may be most impactful, vaccine pipeline data were collected as a snapshot of progress towards each pathogen/disease that was included in the 2025 pathogen priority list.

Table 3 summarizes the clinical development stage for the current, most advanced vaccine candidates (as of 2025) and the suggested R&D focus area; non-active or failed clinical trials are not included.

Table 3. Development category of most advanced vaccine candidate and R&D focus area for priority pathogens/diseases
Development category of most advanced vaccine candidate	R&D focus area	Diseases or pathogens
Phase 3 or authorised	Advanced clinical research; Applied/population health research/Regulation^{Table 3 Footnote a}: special populations, concurrent vaccine administration; Implementation/Surveillance/Expanded indication: large-scale clinical trials, public health and/or clinical implementation, ongoing monitoring (safety, effectiveness), and adaptation of vaccines for broader or new uses.	Clostridioides difficile Cytomegalovirus (CMV) Gonorrhea (Neisseria gonorrhoeae) Group B streptococcal disease (Streptococcus agalactiae) Lyme disease (Borrelia burgdorferi) Tuberculosis (Mycobacterium tuberculosis)^{Table 3 Footnote b}^{Table 3 Footnote c} Mpox^{Table 3 Footnote b} Norovirus Pertussis (Bordetella pertussis)^{Table 3 Footnote b} Rabies^{Table 3 Footnote b} COVID-19 (SARS-CoV-2)^{Table 3 Footnote b} Influenza (due to identified seasonal influenza viruses)^{Table 3 Footnote b}
Phases 1-2	Basic and early clinical vaccine science research: early clinical testing in humans to assess safety, optimal dosing, and immunogenicity; ongoing need for basic vaccine research.	Chlamydia (Chlamydia trachomatis) Escherichia coli (ETEC^{Table 3 Footnote b} only) Group A streptococcus (Streptococcus pyogenes) Haemophilus influenzae, non- type b^{Table 3 Footnote d} Herpes simplex virus 2^{Table 3 Footnote e} Human immunodeficiency virus (HIV) Human metapneumovirus Klebsiella pneumoniae Staphylococcus aureus (MRSA, VISA, VRSA) West Nile virus
Pre-clinical^{Table 3 Footnote f}	Basic vaccine science: research aimed to understand the biology between host-pathogen, identifying antigen targets, vaccine platform development, etc.	Anaplasmosis (Anaplasma phagocytophilum) Babesiosis (Babesia species) Helicobacter pylori Hepatitis C Pseudomonas aeruginosa Escherichia coli (STEC only) Syphilis (Treponema pallidum) Vancomycin-resistant Enterococci (VRE)
Acronyms ETEC: Enterotoxigenic Escherichia coli MRSA: Methicillin-resistant Staphylococcus aureus STEC: Shiga toxin-producing Escherichia coli VISA: Vancomycin-Intermediate Staphylococcus aureus VRSA: Vancomycin-resistant Staphylococcus aureus Table 3 Footnote a Includes research to inform authorization decisions Return to Table 3 footnote a referrer Table 3 Footnote b This pathogen/disease has at least one authorized vaccine in Canada. Return to Table 3 footnote b referrer Table 3 Footnote c The BCG vaccine, though authorized by Health Canada, is not recommended for routine use in tuberculosis prevention in Canada. It is part of the publicly-funded childhood vaccination program only in the Northwest Territories and Nunavut. In other parts of Canada, it is also used for tuberculosis prevention in infants in high-risk communities. Bacille Calmette-Guérin (BCG) vaccine: Canadian Immunization Guide Return to Table 3 footnote c referrer Table 3 Footnote d Haemophilus influenzae non-b refers to invasive disease caused by serotypes a, c, d, e, f, undifferentiated or non-typeable isolates. Return to Table 3 footnote d referrer Table 3 Footnote e For Herpes simplex 2, no prophylactic vaccines were identified but the furthest development stage reached for a therapeutic vaccine candidate was Phase 1/2. Return to Table 3 footnote e referrer Table 3 Footnote f This category includes pathogens/VPDs where no candidate vaccines under active investigation were identified in publicly-available information (as of last search on 2025). Pathogens classified here may have had previous candidates that entered clinical trials but did not progress further or those with candidates approaching early clinical development whose status has not yet been publicly disclosed. Return to Table 3 footnote f referrer

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2026-03-05

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