Author(s):
Question: a
Setting:
Bibliography:
Certainty assessment № of patients Effect Certainty Importance
№ of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations ChAdOx1 MenACWY Relative
(95% CI)
Absolute
(95% CI)
Incidence of participants with positive test for SARS-CoV-2 infectionbc
1 d
randomised trials
not serious e
not serious
serious f
not serious
none
161/8597
346/8580
Rate ratio 0.46
(0.38 to 0.55)
-- per 1000 patient(s) per years
(from -- to --)

MODERATE
Incidence of symptomatic COVID-19 confirmed with positive test for SARS-CoV-2bc
1 d
randomised trials
not serious e
not serious
serious f
not serious
none
84/8597
248/8580
Rate ratio 0.33
(0.26 to 0.43)
-- per 1000 patient(s) per years
(from -- to --)

MODERATE
Incidence of hospitalization or death due to confirmed COVID-19bc
1 d
randomised trials
not serious
not serious
serious f
serious g
none
0/12408 (0.0%)
9/12104 (0.1%)
RR 0.05
(0.00 to 0.88)
71 fewer per 100,000
(from 9 fewer to --)

LOW
Severe or critical disease due to COVID-19bh
1 i
randomised trials
not serious
not serious
serious f
very serious j
none
0/12021 (0.0%)
1/11724 (0.0%)
RR 0.33
(0.01 to 7.98)
6 fewer per 100,000
(from 8 fewer to 60 more)

VERY LOW
All-cause mortality bk
1 i
randomised trials
not serious
not serious
serious f
very serious j
none
1/12282 (0.0%)
4/11962 (0.0%)
RR 0.49
(0.09 to 2.66)
17 fewer per 100,000
(from 30 fewer to 56 more)

VERY LOW
Incidence of any adverse eventsbl
1 i
randomised trials
not serious
not serious
serious f
not serious
none
95/12021 (0.8%)
126/11724 (1.1%)
RR 0.74
(0.56 to 0.96)
279 fewer per 100,000
(from 473 fewer to 43 fewer)

MODERATE
Incidence of serious adverse events (SAEs)bk
1 i
randomised trials
not serious
not serious
serious f
serious m
none
108/12282 (0.9%)
127/11962 (1.1%)
RR 0.83
(0.64 to 1.07)
180 fewer per 100,000
(from 382 fewer to 74 more)

LOW

CI: Confidence interval; RR: Risk ratio

Explanations

a. Last updated: February 26, 2021
b. Pooled interim analysis of COV001, COV002, COV003 and COV005
c. >14 days after second dose; median follow-up 4 months
d. AstraZeneca: Voysey M, 2021
e. Despite some concerns with deviations from intervention, not downgraded for risk of bias.
f. Indirectness downgraded by one level: data are from an interim analysis of the trial, with a short duration of follow-up. Estimates may change over a longer duration of follow-up.
g. Imprecision downgraded by one level: due to few events observed.
h. >14 days after second dose; median follow-up 2 months
i. AstraZeneca: Voysey M, 2020
j. Imprecision downgraded by 2 levels: due to wide confidence interval consistent with the possibility for benefit and the possibility for harm and few events.
k. mean follow-up 4.1 months
l. median follow-up 3.4 months
m. Imprecision downgraded by 1 level: due to wide confidence interval consistent with the possibility for no effect and the possibility for benefit.