| PROVENT |
Low risk of bias |
Participants were randomized via random number generation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomization. |
Low risk of bias |
Participants could be unblinded to consider vaccination, but percentages of participants with data that were unblinded were
balanced between the groups. The analysis was appropriate. |
Low risk of bias |
Data for this outcome was available for all participants (5172/5172 participants randomized). |
Some concerns |
The measurement of the outcome was appropriate, and it is unlikely that it differed between intervention groups. Outcome assessors were probably aware of the intervention received, but the number of participants vaccinated was comparable in both arms. |
Some concerns |
There is a trial protocol, which provided details of the pre‐specified outcomes, but the outcome COVID‐19 related hospital admissions and the 6 months follow‐up were probably not pre‐specified. |
Some concerns |
For this outcome, there is a low risk of bias from randomisation process, deviations from intended interventions and missing outcomes. There are some concerns for bias due measurement of the outcome and selection of reported results. |
