Table 3. Open in new tab Priorities for...

	Objective
ARF	Age-specific incidence and changes over time HICs: Unlikely to be a driver except in First Nation sub-populations	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation HICs: Relevant for First Nation sub-populations LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific incidence and changes over time. Attack rates from acute diseases to ARF (difficult to obtain) HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment HICs: Relevant for First Nation sub-populations
RHD	Prevalence in certain at-risk groups HICs: Relevant for First Nation sub-populations LMICs: Severity of RHD	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific prevalence and temporal changes Need to understand progression from acute infection (pharyngitis) to estimate long-term reduction from pharyngitis prevention HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations, treatment, and mortality HICs: Relevant for First Nation sub-populations
APSGN	Not a critical driver for advocacy	Not required as efficacy needs to be demonstrated for pharyngitis	Plan for post-licensure evaluation of impact	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment LMICs: Potential impact on long-term chronic renal disease

Objective

Clinical Endpoint

Advocacy

Regulatory/Licensure

Policy and Post-Licensure Evaluation

Financing

ARF

Age-specific incidence and changes over time

HICs:

Unlikely to be a driver except in First Nation sub-populations

Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation

HICs:

Relevant for First Nation sub-populations

LMICs:

Determination of pathway for evaluating impact on severe disease outcomes from early acute infection

Age-specific incidence and changes over time.
Attack rates from acute diseases to ARF (difficult to obtain)

HICs:

Relevant for First Nation sub-populations

LMICs:

Data on socioeconomic indicators
Progression from acute infection

Retrospective economic (cost of illness) data targeted to hospitalizations and treatment

HICs:

Relevant for First Nation sub-populations

RHD

Prevalence in certain at-risk groups

HICs:

Relevant for First Nation sub-populations

LMICs:

Severity of RHD

Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation

LMICs:

Determination of pathway for evaluating impact on severe disease outcomes from early acute infection

Age-specific prevalence and temporal changes
Need to understand progression from acute infection (pharyngitis) to estimate long-term reduction from pharyngitis prevention

HICs:

Relevant for First Nation sub-populations

LMICs:

Data on socioeconomic indicators
Progression from acute infection

Retrospective economic (cost of illness) data targeted to hospitalizations, treatment, and mortality

HICs:

Relevant for First Nation sub-populations

APSGN

Not a critical driver for advocacy

Not required as efficacy needs to be demonstrated for pharyngitis

Plan for post-licensure evaluation of impact

Retrospective economic (cost of illness) data targeted to hospitalizations and treatment

LMICs:

Potential impact on long-term chronic renal disease

	Objective
ARF	Age-specific incidence and changes over time HICs: Unlikely to be a driver except in First Nation sub-populations	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation HICs: Relevant for First Nation sub-populations LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific incidence and changes over time. Attack rates from acute diseases to ARF (difficult to obtain) HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment HICs: Relevant for First Nation sub-populations
RHD	Prevalence in certain at-risk groups HICs: Relevant for First Nation sub-populations LMICs: Severity of RHD	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific prevalence and temporal changes Need to understand progression from acute infection (pharyngitis) to estimate long-term reduction from pharyngitis prevention HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations, treatment, and mortality HICs: Relevant for First Nation sub-populations
APSGN	Not a critical driver for advocacy	Not required as efficacy needs to be demonstrated for pharyngitis	Plan for post-licensure evaluation of impact	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment LMICs: Potential impact on long-term chronic renal disease

Table 3.

Open in new tab

Priorities for Data Requirements Describing Burden of Disease Across Vaccine Development and Evaluation Objectives for Immune-Mediated Sequalae of Group A Streptococcus

	Objective
Clinical Endpoint	Advocacy	Regulatory/Licensure	Policy and Post-Licensure Evaluation	Financing
ARF	Age-specific incidence and changes over time HICs: Unlikely to be a driver except in First Nation sub-populations	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation HICs: Relevant for First Nation sub-populations LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific incidence and changes over time. Attack rates from acute diseases to ARF (difficult to obtain) HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment HICs: Relevant for First Nation sub-populations
RHD	Prevalence in certain at-risk groups HICs: Relevant for First Nation sub-populations LMICs: Severity of RHD	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific prevalence and temporal changes Need to understand progression from acute infection (pharyngitis) to estimate long-term reduction from pharyngitis prevention HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations, treatment, and mortality HICs: Relevant for First Nation sub-populations
APSGN	Not a critical driver for advocacy	Not required as efficacy needs to be demonstrated for pharyngitis	Plan for post-licensure evaluation of impact	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment LMICs: Potential impact on long-term chronic renal disease

	Objective
Clinical Endpoint	Advocacy	Regulatory/Licensure	Policy and Post-Licensure Evaluation	Financing
ARF	Age-specific incidence and changes over time HICs: Unlikely to be a driver except in First Nation sub-populations	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation HICs: Relevant for First Nation sub-populations LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific incidence and changes over time. Attack rates from acute diseases to ARF (difficult to obtain) HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment HICs: Relevant for First Nation sub-populations
RHD	Prevalence in certain at-risk groups HICs: Relevant for First Nation sub-populations LMICs: Severity of RHD	Not critical as initial efficacy needs to be demonstrated for pharyngitis and impetigo but need to plan for post-licensure evaluation LMICs: Determination of pathway for evaluating impact on severe disease outcomes from early acute infection	Age-specific prevalence and temporal changes Need to understand progression from acute infection (pharyngitis) to estimate long-term reduction from pharyngitis prevention HICs: Relevant for First Nation sub-populations LMICs: Data on socioeconomic indicators Progression from acute infection	Retrospective economic (cost of illness) data targeted to hospitalizations, treatment, and mortality HICs: Relevant for First Nation sub-populations
APSGN	Not a critical driver for advocacy	Not required as efficacy needs to be demonstrated for pharyngitis	Plan for post-licensure evaluation of impact	Retrospective economic (cost of illness) data targeted to hospitalizations and treatment LMICs: Potential impact on long-term chronic renal disease

Abbreviations: APSGN, acute post-streptococcal glomerulonephritis; ARF, acute rheumatic fever; HIC, high-income country; LMIC, low- and middle-income country; RHD, rheumatic heart disease.

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