Table 2.
BBV152 vaccine efficacy against SARS-CoV-2 after at least 14 days after the second dose in the per-protocol population (N=16 973)
| Total cases | BBV152 | Placebo | Vaccine efficacy, % (95% CI)* | |
|---|---|---|---|---|
| Symptomatic COVID-19 | 130/16 973 (0·8%) | 24/8471 (0·3%) | 106/8502 (1·2%) | 77·8% (65·2–86·4) |
| Severe symptomatic COVID-19 | 16/16 973 (0·1%) | 1/8471 (<0·1%) | 15/8502 (0·2%) | 93·4% (57·1–99·8) |
| Symptomatic COVID-19 in participants aged 18–59 years | 109/15 115 (0·7%) | 19/7578 (0·3%) | 90/7537 (1·2%) | 79·4% (66·0–88·2) |
| Symptomatic COVID-19 in participants aged ≥60 years | 21/1858 (1·1%) | 5/893 (0·6%) | 16/965 (1·7%) | 67·8% (8·0–90·0) |
| Symptomatic COVID-19 in participants with a pre-existing chronic medical condition | 49/4846 (1·0%) | 12/2328 (0·5%) | 37/2518 (1·5%) | 66·2% (33·8–84·0) |
| Asymptomatic COVID-19 | 46/6289 (0·7%) | 13/3248 (0·4%) | 33/3041 (1·1%) | 63·6% (29·0–82·4) |
| Symptomatic and asymptomatic COVID-19 | 75/6289 (1·2%) | 19/3248 (0·6%) | 56/3041 (1·8%) | 68·8% (46·7–82·5) |
Data are n/N (%) unless otherwise stated.
95·006% CI used for primary analysis of symptomatic COVID-19 to adjust for interim analyses, 95% CI otherwise. Primary efficacy was based on the per-protocol population, including randomly assigned participants who were seronegative at baseline and received two doses of either vaccine or placebo, and remained on study at least 14 days after their second dose with no RT-PCR-confirmed SARS-CoV-2 infection before the start of efficacy follow-up. Symptomatic COVID-19 cases were defined as occurring in participants who had at least two symptoms that included fever (temperature ≥38°C), chills, new cough, myalgia, headache, sore throat, diarrhoea, nausea, or congestion; or at least one event of new-onset anosmia or ageusia, a respiratory sign or symptom (shortness of breath or difficulty breathing, oxygen saturation <94% or requirement for supplemental oxygen, or radiographic evidence of pneumonia), evidence of shock, or intensive care admission or death; and at least one nasopharyngeal swab that was PCR-positive for SARS-CoV-2.