Prototype: Near real-time monitoring of the anticipated benefit-risk of vaccines post-marketing

Case study: Rotavirus vaccination in the UK (simulated data)

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Working document on the Benefit-Risk Monitoring application presented at the 7th GAM and ADVANCE FORUM: click here

Figure: Weekly number of doses

Specify age groups (in weeks)

Weekly number of doses

C1. Dose 1: number of doses

Number of doses (dose 1) extrapolated to the whole UK population by age groups (as specified above), by calendar time (in weeks).


C2. Dose 2: number of doses

Number of doses (dose 2) extrapolated to the whole UK population by age groups (as specified above), by calendar time (in weeks).


Figure: Weekly rotavirus vaccine uptake

Specify ages (in weeks)

C3. Dose 1: coverage (%)

Coverage (%) in children who had reached a certain age (as specified above) by calendar time (in weeks) for dose 1.


C4. Dose 2: coverage (%)

Coverage (%) in children who had reached a certain age (as specified above) by calendar time (in weeks) for dose 2.


Figure: Coverage by monthly birth cohort

C5. Dose 1: coverage (%)

Age-specific coverage (%) by monthly birth cohort for dose 1.


C6. Dose 2: coverage (%)

Age-specific coverage (%) by monthly birth cohort for dose 2.


Figure: Incidence rate (/10.000 person years) of intussusception

R1. Dose 1 - Risk Window 1 (1-7 days)

Incidence rate per 10.000 person years [95% CI] of intussusception estimated cumulatively over time, baseline incidence prior to vaccination introduction (age 8 to 10 weeks) and incidence 1-7 days after dose 1.


R2. Dose 1 - Risk Window 2 (8-21 days)

Incidence rate per 10.000 person years [95% CI] of intussusception estimated cumulatively over time, baseline incidence prior to vaccination introduction (age 9 to 12 weeks) and incidence 8-21 days after dose 1.


R3. Dose 2 - Risk Window 1 (1-7 days)

Incidence rate per 10.000 person years [95% CI] of intussusception estimated cumulatively over time, baseline incidence prior to vaccination introduction (age 12 to 14 weeks) and incidence 1-7 days after dose 1.


R4. Dose 2 - Risk Window 2 (8-21 days)

Incidence rate per 10.000 person years [95% CI] of intussusception estimated cumulatively over time, baseline incidence prior to vaccination introduction (age 13 to 16 weeks) and incidence 8-21 days after dose 1.


Width of moving windows (in weeks)

Baseline incidences (/10.000 person years)

Vaccine Effectiveness

Figure: Running incidence rate (/ 10.000 person years) of acute gastroenteritis (AGE), total population

B1. GP Visits

Incidence rate per 10.000 person years [95% CI] of AGE GP visits in total population with a lookback period specified above.


B2. Hospital Admissions

Incidence rate per 10.000 person years [95% CI] of AGE hospital admissions in total population with a lookback period specified above.


Figure: Benefit-Risk of rota-virus vaccination, total population (observed benefits)

Width of moving windows (in weeks) for benefits

Weights for Benefit-Risk

BRT1. Benefit - Risk Difference

Benefit-risk difference [95% CI] in a partially vaccinated population of 10.000 children followed from birth till 1 year of age. The benefit-risk difference is calculated as a weighted sum of the population-level observed vaccine prevented disease burden (baseline incidence minus incidence post-vaccination) and the weighted population-level vaccine induced disease burden (excess incidence). The coverage of the population is as observed. The length of the lookback period for the benefits and the weights and baseline values for the benefit-risk measures are specified above.


BRT2. Benefit - Risk Ratio

Average benefit-risk ratio [95% CI] for children followed from birth till 1 year of age from a partially vaccinated population. The benefit-risk ratio is calculated as the weighted vaccine prevented disease burden (baseline incidence minus incidence post-vaccination) to the weighted vaccine induced disease burden (excess incidence). The coverage of the population is as observed. The length of the lookback period for the benefits and the weights and baseline values for the benefit-risk measures are specified above.


Figure: Benefit-Risk of rota-virus vaccination, vaccinated population (expected benefits)

Width of moving windows (in weeks) for benefits

Weights for Benefit-Risk

Baseline incidences (/10.000 person years)

Vaccine Effectiveness

BRT3. Benefit - Risk Difference

Benefit-risk difference [95% CI] per 10.000 vaccinated children followed from birth till 1 year of age. The benefit-risk difference is calculated as a weighted sum of the theoretical vaccine prevented disease burden (baseline incidence minus incidence in vaccinated subjects given the expected vaccine effectiveness as specified above) and the weighted vaccine induced disease burden (excess incidence). The weights and baseline values are specified above.


BRT4. Benefit - Risk Ratio

Benefit-risk ratio [95% CI] for vaccinated children followed from birth till 1 year of age. The benefit-risk ratio is calculated as the weighted theoretical vaccine prevented disease burden (baseline incidence minus incidence in vaccinated subjects given the expected vaccine effectiveness as specified above) to the weighted vaccine induced disease burden (excess incidence). The weights and baseline values are specified above.