COVAIL

Using Stage-2 and Stage-4 data, estimated Stage-4 BA.4/5 + Prototype cumulative incidence was 4.8% at Day 91 and 6.8% at Day 188. A COVAIL diagnostic analysis found evidence against the no controlled direct effects assumption. The COVAIL d…

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Using Stage-2 and Stage-4 data, estimated Stage-4 BA.4/5 + Prototype cumulative incidence was 4.8% at Day 91 and 6.8% at Day 188. A COVAIL diagnostic analysis found evidence against the no controlled direct effects assumption. The COVAIL diagnostic suggested that Day 15 BA.4/BA.5 neutralizing antibody titer did not capture all relevant pathways. The COVAIL case study used Stages 2 and 4. Stage 2 included 154 per-protocol participants assigned to Omicron-containing vaccines and 47 assigned to monovalent Prototype vaccine.