More details about outcomes and disease severity

List of outcomes:

Critical outcomes:
  • Incidence of participants with positive test for SARS-CoV-2 infection by RT-PCR OR Nucleic acid amplification testing (NAAT) or other validated test (symptomatic or asymptomatic)
  • Incidence of symptomatic COVID-19 confirmed with positive test for SARS-CoV-2 infection by RT-PCR OR NAAT
  • Incidence of hospitalization or death due to confirmed COVID-19
  • Severe or critical disease defined according to the WHO definition or as reported by trialists (collect definition)
  • All-cause mortality
  • Incidence of any adverse events
  • Incidence of serious adverse events (SAEs)

    Important outcomes:

  • Incidence of local adverse events (D7)
  • Incidence of systemic adverse events (D14)
  • Incidence of withdrawal due to adverse events

    Methods

    For phase 1-2 studies, we report on the general charecteristics and assess the risk of Bias for safety outcomes only.Results from phase1-2 studies are included in forest plots for the chosen vaccine dose and schedule.

    For phase 2-3 trials we provide the evidence synthesis with forest plots and summary of findings table and evidence profile.

    Results for each vaccine comparisons are the summary of evidence from the latest study report results.