Primary Objectives:

  • To assess occurrence of severe COVID-19 disease among individuals vaccinated with two doses of AZD1222.
  • To assess adverse events (AEs) among individuals vaccinated with at least one dose AZD1222 overall and by age group, comorbidity group, number of vaccine doses, and the time since the first or second dose.

Secondary Objectives:

  • To assess occurrence of severe COVID-19 disease among individuals vaccinated with at least one dose of AZD1222 by age group, comorbidity group, severity of disease, number of vaccine doses, and the time since the first or second dose.
  • To estimate the incidence of symptomatic SARS-CoV-2 infections in a subcohort of study participants among individuals vaccinated with at least one dose of AZD1222.

Study Design: This is a single-arm, open-label, interventional, Phase 3b study to determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity, and deaths and attributable adverse events (AEs) in subjects in Botswana given 1 to 2 injections of AZD1222 8 to 12 weeks apart and followed up to 12 months following the first vaccination dose.

Study Population and Size: Both males and females who are ≥ 18 years of age at the time of the study. The total target sample size will be 50,000 to 100,000 participants. 

Study Duration: 15-18 months

Sponsor: Botswana Ministry of Health (in collaboration with Botswana Harvard Partnership and AstraZeneca).