Table 2

Data extraction sheet

Licensure dataRecommendationsEvidence
Vaccine preventable disease:
Committee identification
Name of the Advisory committee
Country of the Committee
NITAG member: Yes/No
Qualitative information
Study/document Information:
Title of publication
Year of Publication
Type of document:
  • Peer review literature

  • Unpublished data

  • Expert opinion

  • Epidemiological data

  • Article

  • Other

Journal name
Study Design
Study period
Country(s) in which it took place
Calendar years in follow-up period
Conflicts of Interest declared by authors
  • Trade name of vaccine

  • Abbreviation / Proper name

  • Manufacturer

  • Licensure date

  • Date of implementation in a vaccination programme

  • country of licensure

Title of the recommendation
Date of publication of the recommendation
Name of journal of publication, or not
Implementation in an immunisation programme: Yes/No
Population under study:
Initial sample size recruited, N, records numbers,
  • N and % Males

  • N and % Females

Age range
Average age
Sample size with full follow-up data available
  • N and % Males

  • N and % Females

Age range
Average age
Medical Comorbidities or Immunosuppressed condition (complete list if different)

  • Sickle cell disease,

  • Nephrotic syndrome,

  • Asplenia,

  • Cancer

  • Asthma

  • COPD

  • Diabetes

  • Thyroid disorders

  • IBD

Lifestyle factors:
  • Exposure to tobacco smoke.

  • Overweight

  • Malnutrition

  • Day care attendance

  • Lack of breastfeeding

  • Therapeutic indication

  • Posology, doses, no of shots in routine series

  • Approved ages

  • Specific population groups, sex

  • Method of administration

Discussion structure
Use of a framework Yes/No
Name of the framework
Use of Theoretical concept Yes/No
Name of the concept
Use of a standard operation procedure Yes/No
Name of the SOP
Off-label vaccine intervention (Exposure):
Name of vaccine
Quantity of type of strains protected against
Dose per shot
No and timing of doses
Measurement instrument/method, specific
Calendar years intervention measured
Immunisation schedule
Group of the population
Off-label characteristics
Outcome measure:
Immunogenicity serological threshold antibody levels
Vaccine effectiveness (endpoint measure)
Vaccine impact
Vaccine safety
Immunologic non-inferiority (indicate δ)
Incidence of the disease
Clinical criteria used for the disease
Method of disease measurement/diagnosis
Population description (inclusion/exclusion)
Randomisation process for RCTs (RCTs)
Assessment of exposure status (cohort)
Age groups: N, % in each
  • <1; 1–4; 5–9; 10–14; 15–18;

  • 19–24; 25–29; 30–39; 40–59;

  • ≥60;

Sex (N, % F - N, % M)
Prior vaccination
Vaccination interval different for intervention versus control arm
  • Antigen

  • Adjuvant

  • Protein

  • Other components

  • Live or attenuated vaccine

  • Bacteria, virus, toxoid, protozoan

  • Wild strain or not, no of strains

Decision elements, approach used
  • GRADE Summary table available Yes/No

  • Policy question—PICO

  • Desirable effects

  • Undesirable effects

  • Desirable effects outweigh the undesirable effects

  • Outcomes of interest (critical, important etc)

  • No of studies per outcome

  • Evidence retrieval/exclusion criteria

Rating the quality of evidence
(each study):
  • Design (RCTs, Observational)

  • Risk of bias

  • Inconsistency

  • Indirectness

  • imprecision

  • Evidence type/level

  • Efficacy

  • Effectiveness

  • Impact

  • No Needed to Vaccinate

The final recommendation:
  • Evidence tables available Yes/No

  • Question—PICO

  • Background

Evidence for the following factors:
  • Statement of problem (for each criteria)

  • Benefits and harms (for each criteria)

  • Values and preferences of target population (for each criteria)

  • Acceptability to stakeholders

  • Resource use

  • Feasibility

  • Balance of consequences

  • Type of recommendations

  • Recommendation

Additional considerations
C. Other approach
List the items evaluated
Quantitative information (for studies)

Effect measures (yes/no)
OR, RR or HR rates n/N
  • Population

  • Sex

  • Age group

  • Fertility, pregnancy and lactation

  • Serological threshold

  • Antibody level

Other information → accessible written evidence
  • Vaccine updates

  • Others

  • COPD, Chronic obstructive pulmonary disease; EtR, evidence to recommendations; GRADE, Grading of Recommendations Assessment, Development and Evaluation; IBD, Inflammatory bowel disease; NITAG, National Immunisation Technical Advisory Group; PICO, patient/Population, Intervention, Comparison and Outcomes; RCTs, randomised controlled trials; SOP, Standard operating procedure.