suggested 95 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
suggested 93 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias
demonstrated 94 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
demonstrated 98 % decrease in severe COVID-19 occurrence (PE) with a moderate degree of certainty due to some concern in risk of bias
statistically significant 14 % increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
statistically significant 17.4-fold increase in arthralgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 41 % increase in hypersensitivity, all terms with a moderate degree of certainty due to some concern in risk of bias
statistically significant 2.5-fold increase in lymphadenopathy, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 26.6-fold increase in myalgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 42.3-fold increase in fever, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 32.7-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 14.0-fold increase in local adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 5.7-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
statistically significant 8.5-fold increase in systemic adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
No deaths or unsolicited AEs that led to discontinuation from study vaccine or the study occurred within 28 days. One SAE of community-acquired pneumonia occurred on day 33 at 50 µg mRNA-1273 in the older cohort, resolved on day 58 and led to study vaccine discontinuation.
PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).
delta: difference in rate or median (if available)
