VAC4EU Postauthorisation Effectiveness Study of BIMERVAX® Vaccine in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BIMERVAX (--) - EMULSION FOR INJECTION
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 VACCINE (RECOMBINANT, ADJUVANTED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN04) covid-19, protein subunit

  covid-19, protein subunit
• Medical condition to be studied:
  COVID-19

Population studied

• Short description of the study population:
  The eligible population will be all individuals who have received a booster dose of BIMERVAX® or a comparator COVID 19 vaccine and are actively enrolled in one of the selected European health data sources for at least 12 months before receipt of the booster vaccination. The study period will be from the date of availability of BIMERVAX® vaccine in each participant country to 2 to 3 years past that date, pending the timing and potential seasonality of booster administration campaigns.
• Age groups:
  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Frail population

  Immunocompromised

  Pregnant women

Study design details

• Study design:
  A cohort design will be used to estimate the effectiveness of BIMERVAX® on COVID 19–related outcomes compared with other COVID 19 booster vaccines.
• Main study objective:
  Overall research question: What is the relative effectiveness of receiving BIMERVAX® as a booster vaccine on COVID 19–related outcomes compared with receipt of another authorised COVID 19 vaccine as a booster?; ; Objectives:; The primary objective is to estimate the effect of BIMERVAX® on the following COVID 19–related outcome compared with other COVID 19 vaccines authorised for the booster indication:; Primary outcome: COVID 19–requiring a hospitalisation or emergency department (ED) visit; ; The secondary objective is to estimate the effect of BIMERVAX® on the following COVID 19–related outcome compared with other COVID 19 vaccines authorised for the booster indication:; Secondary outcome: COVID 19 diagnosis in any setting
• Setting:
  The population studied is that described in section 13. The eligible population will be all individuals who have received a booster dose of BIMERVAX® or a comparator COVID 19 vaccine and are actively enrolled in one of the selected European health data sources for at least 12 months before receipt of the booster vaccination. The study period will be from the date of availability of BIMERVAX® vaccine in each participant country to 2 to 3 years past that date, pending the timing and potential seasonality of booster administration campaigns.
• Comparators:
  Other COVID 19 vaccines with the same booster indication.
• Outcomes:
  The primary COVID 19–related outcome evaluated by this study will be as follows:; • COVID 19 requiring a hospitalisation or an ED visit, defined as a diagnosis of COVID 19 leading to a hospital admission or an ED visit; ; In addition to the primary hospital/ED–based definition, the following broader secondary outcome will also be evaluated.; • COVID 19 diagnosis, defined as a medical diagnosis of COVID 19 occurring in any healthcare encounter: in a hospital, an ED, or an outpatient setting
• Data analysis plan:
  The cohort study will estimate the risk of COVID 19 related outcomes in individuals receiving BIMERVAX® compared with individuals receiving a contemporary COVID 19 vaccine also authorised for booster indication. The data analysis will be characterised by the following:; • Baseline will be defined as the date on which eligible individuals receive the booster vaccine (BIMERVAX® or a comparator vaccine). Follow-up starts and eligibility criteria are applied at baseline.; Eligible vaccinated individuals will be followed from baseline until the occurrence of a COVID-19–related outcome, death, disenrolment from the data source, or end of the study period, whichever occurs first.; • The study will estimate the effect of receiving 1 dose of BIMERVAX® as a booster vaccine versus the effect of receiving 1 booster dose of other COVID 19 vaccines. Standard epidemiological methods will be used to achieve baseline exchangeability conditional on the measured confounders.; • Outcomes will be treated as time-to-event variables and will be analysed accordingly. Effect estimates will be provided in both relative (e.g., risk ratio) and absolute (e.g., risk differences) scales. Relative vaccine effectiveness will be estimated as 1 minus the risk ratio.