Table 2

Data extraction sheet

Licensure data	Recommendations	Evidence
Monography Vaccine preventable disease:	Committee identification Name of the Advisory committee Country of the Committee NITAG member: Yes/No	Qualitative information Study/document Information: Authors Title of publication Year of Publication Type of document: Peer review literature Unpublished data Expert opinion Epidemiological data Article Other Journal name Study Design Aims/purpose Study period Country(s) in which it took place Calendar years in follow-up period Conflicts of Interest declared by authors
Identification Trade name of vaccine Abbreviation / Proper name Manufacturer Licensure date Date of implementation in a vaccination programme country of licensure	Recommendation 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) HIV/AIDS; 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
Typology 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 Methods: 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) Immunodepression Prior vaccination Vaccination interval different for intervention versus control arm
Composition Antigen Adjuvant Protein Other components Live or attenuated vaccine Bacteria, virus, toxoid, protozoan Wild strain or not, no of strains	Decision elements, approach used A. GRADE36 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: B. ETR6 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 SD CI Variance Adjusted/unadjusted
Contraindication Population Sex Age group Fertility, pregnancy and lactation
Immunogenicity 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.