Table 2.
Summary of findings for safety outcomes in clinical trials
| Treatment comparison (reference: placebo) | Study group (N/total) | Pooled RR (95%CI) | |
|---|---|---|---|
| Treatment | Control | ||
| Local reaction (16 vaccines on 5 platforms) | |||
| Inactivated vaccines | 10,276/33,901 | 7674/20,033 | 0.9 (0.8–1.1) |
| RNA vaccines | 18,442/20,443 | 5393/20,428 | 4.0 (2.9–5.4) |
| Non-replicating vector vaccines | 3753/6169 | 1926/6003 | 2.6 (1.6–4.4) |
| Protein subunit vaccines | 203/493 | 45/485 | 4.5 (3.4–5.9) |
| DNA vaccines | 66/167 | 11/50 | 1.8 (1.0–3.1) |
| Systemic reaction (16 vaccines on 5 platforms) | |||
| Inactivated vaccines | 10,682/33,919 | 6764/20,033 | 1.0 (1.0–1.0) |
| RNA vaccines | 16,440/20,443 | 10,505/20,429 | 1.6 (1.5–1.6) |
| Non-replicating vector vaccines | 3843/6169 | 2694/6003 | 1.5 (1.2–1.9) |
| Protein subunit vaccines | 148/493 | 105/485 | 1.4 (1.2–1.8) |
| DNA vaccines | 49/167 | 19/50 | 0.8 (0.5–1.2) |
| Medically attended events* (2 vaccines on 2 platformss) | |||
| RNA vaccines | 140/15,185 | 83/15,166 | 1.7 (1.3–2.2) |
| Non-replicating vector vaccines | 304/21,895 | 408/21,888 | 0.7 (0.6–0.9) |
| SAE* (8 vaccines on 3 platforms) | |||
| Inactivated vaccines | 156/33,137 | 109/19,647 | 0.8 (0.7–1.0) |
| RNA vaccines | 223/37,937 | 201/37,926 | 1.1 (0.9–1.3) |
| Non-replicating vector vaccines | 207/50,343 | 208/39,047 | 0.8 (0.7–1.0) |
| SAE related to vaccination* (8 vaccines on 3 platforms) | |||
| Inactivated vaccines | 2/33,137 | 0/19,647 | 5.0 (0.2–104.0) |
| RNA vaccines | 10/37,937 | 4/37,926 | 2.3 (0.5–10.6) |
| Non-replicating vector vaccines | 10/50,343 | 8/39,047 | 2.4 (0.7–7.8) |
AEFI adverse event following immunization, RR random-effect risk ratio, CI confidence intervals, N total number of subjects experiencing one or more AEFI. Per-protocol analysis
*Only considering AEFIs in phase 3 trials