Table 2.
Efficacy of CVnCoV against virologically confirmed COVID-19 occurring 15 days or more after the second dose in the primary efficacy analysis set
|
CVnCoV |
Placebo |
Vaccine efficacy (95% CI) | |||
|---|---|---|---|---|---|
| n/N | Person-years | n/N | Person-years | ||
| COVID-19 of any severity | |||||
| Overall | 83/12 851 | 1735·29 | 145/12 211 | 1569·87 | 48·2% (31·0–61·4)* |
| 18–60 years | 71/11 532 | 1591·47 | 136/11 031 | 1449·23 | 52·5% (36·2–64·8) |
| ≥61 years | 12/1319 | 143·82 | 9/1180 | 120·64 | ..† |
| COVID-19 of any severity by region‡ | |||||
| Europe | 21/4091 | 684·22 | 33/3919 | 604·83 | 43·7% (−0·2 to 69·1) |
| Latin America | 62/8760 | 1051·07 | 112/8292 | 965·03 | 49·2% (30·1–63·3) |
| COVID-19 of any severity by strain§ | |||||
| Alpha variant (B.1.1.7/501Y.V2) | 20/11 532 | 1591·47 | 42/11 031 | 1449·23 | 55·1% (23·5–73·6) |
| Gamma variant (P.1/501Y.V3) | 9/11 532 | 1591·47 | 26/11 031 | 1449·23 | 67·1% (29·8–84·6) |
| Lambda variant (C.37) | 13/11 532 | 1591·47 | 26/11 031 | 1449·23 | 52·8% (8·2–75·8) |
| Mu variant (B.1.621) | 11/11 532 | 1591·47 | 17/11 031 | 1449·23 | ..† |
| Other | 7/11 532 | 1591·47 | 13/11 031 | 1449·23 | ..† |
| Moderate-to-severe COVID-19 | |||||
| Overall | 12/12 851 | 1735·29 | 37/12 211 | 1569·87 | 70·7% (42·5–86·1) |
| 18–60 years | 9/11 532 | 1591·47 | 36/11 031 | 1449·23 | 77·2% (51·8–90·4) |
| ≥61 years | 3/1319 | 143·82 | 1/1180 | 120·64 | ..† |
| Severe COVID-19 | |||||
| Overall | 4/12 851 | 1735·29 | 10/12 211 | 1569·87 | ..† |
| 18–60 years | 2/11 532 | 1591·47 | 9/11 031 | 1449·23 | ..† |
| ≥61 years | 2/1319 | 143·82 | 1/1180 | 120·64 | ..† |
For COVID-19 of any severity, the 95·826% CI is provided (due to adjustment for multiplicity across interim analyses).
Not reported; the number of cases was too low to be statistically meaningful.
Vaccine efficacy by region was evaluated post-hoc.
Efficacy against strains was evaluated in adjudicated and sequenced cases in participants aged 18–60 years; other strains includes B.1 lineage SARS-CoV-2.