Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of COVID-19 vaccines in Spain)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  COMIRNATY

  VAXZEVRIA
• Name of medicine, other:
  COVID-19 Vaccine Moderna dispersion for injection, COVID-19 Vaccine Janssen suspension for injection
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX03) covid-19 vaccines

  covid-19 vaccines
• Medical condition to be studied:
  SARS-CoV-2 test positive
• Additional medical condition(s):
  Symptomatic or Asymptomatic Diagnosis of COVID-19,Hospitalisations/Intensive care unit (ICU) admissions for COVID-19 All-Cause Mortality

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

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

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  8

Study design details

• Main study objective:
  This study addresses the research question of whether vaccinations with new licenced COVID 19 vaccines, (Comirnaty, Moderna, AstraZeneca’s and Janssen and subsequently approved vaccines in the EU during the data collection), are effective in reducing the burden of COVID 19 in Spain in comparison with no vaccination person-time.
• Outcomes:
  Primary objective is to evaluate the effectiveness of each COVID-19 vaccine in reducing the covid-19 infections (confirmed through test and regardless the prognosis and clinical phenotype (i.e. whether symptomatic or asymptomatic, mild or severe). Effectiveness of each covid-19 vaccine in reducing asymptomatic or symptomatic COVID-19, Hospitalisations/Intensive care unit (ICU) admissions for COVID 19 and All-cause mortality. Effectiveness of each covid-19 vaccine in reducing the covid-19 infections among different clinical subgroups of patients, and along the time since complete vaccination.
• Data analysis plan:
  Cox proportional hazards regression, yielding a hazard ratio (HR, 95%CI) will be estimated for 0-14 days after D1, 15 after D1 until D2, 0-14 days after D2 and 15-90d,91-180d,and ≥181d after D2 in comparison with similar followed periods from time zero in the unvaccinated group. This method will calculate a single vaccine effectiveness measure for each period of observation (assumed constant over those defined periods) in vaccinated versus unvaccinated groups.Flexible parametrical models will be run for comparison.Crude vaccine effectiveness (1-HR) will be calculated for all outcomes.Backward stepwise selection will be used to identify variables associated with outcome (p-exit≥0.1, p-entry<0.05), that could be confounders and thus adjust the final models. Confounders will be measured at baseline and updated before each vaccine dose or every 28 days. Adjusted time-specific risk differences (at 3, 6, 9, 12 months) will be calculated.Switching among vaccines will be analysed separately.

Documents

Study results

BIFAP_COVID VacEff_Report_ENCEPP