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 NVX-CoV2373 Placebo Relative
(95% CI)
Absolute
(95% CI)
Incidence of participants with positive test for SARS-CoV-2 infection - not reported
-
-
-
-
-
-
-
-
-
-
-
-
Incidence of symptomatic COVID-19 confirmed with positive test for SARS-CoV-2d
2 e
randomised trials
not serious b
serious f
serious g
serious h
none
35/8377
125/8346
Rate ratio 0.23
(0.05 to 1.09)
-- per 1000 patient(s) per years
(from -- to --)

VERY LOW
Severe or critical disease due to COVID-19d
2 e
randomised trials
not serious b
not serious
serious g
very serious i
none
0/8377 (0.0%)
6/8346 (0.1%)
RR 0.16
(0.02 to 1.38)
60 fewer per 100,000
(from 70 fewer to 27 more)

VERY LOW
All-cause mortality j
1 k
randomised trials
not serious b
not serious
serious c
very serious l
none
0/7020 (0.0%)
0/7019 (0.0%)
not estimable

VERY LOW
Any adverse eventsm
4 n
randomised trials
not serious
not serious
serious g
not serious
none
2065/8337 (24.8%)
1692/8330 (20.3%)
RR 1.18
(1.03 to 1.35)
37 more per 1,000
(from 6 more to 71 more)

MODERATE
Serious adverse eventsm
2 e
randomised trials
not serious
not serious
serious g
very serious i
none
43/8053 (0.5%)
42/8054 (0.5%)
RR 1.02
(0.67 to 1.56)
0 fewer per 1,000
(from 2 fewer to 3 more)

VERY LOW

CI: Confidence interval; RR: Risk ratio

Explanations

a. Last updated: 01 July, 2021
b. Despite some concerns with deviations from intervention, not downgraded for risk of bias.
c. 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.
d. Median follow-up: 3 months (Measured from 7 days after the 2nd dose)
e. Heath P, 2021; Shinde V, 2021
f. Inconsistency downgraded by 1 level: I²=91.7%
g. Indirectness downgraded by one level: data are from an interim analyses of the trials, with a short duration of follow-up. Estimates may change over a longer duration of follow-up.
h. Imprecision downgraded by 1 level: due to wide confidence interval consistent with the possibility for no effect and the possibility for benefit.
i. Imprecision downgraded by 2 levels: due to wide confidence interval consistent with the possibility for benefit and the possibility for harm and few events.
j. Median follow-up: 3 months
k. Heath P, 2021
l. Imprecision downgraded by 2 levels: no events in either group
m. Unsolicited adverse events, median follow up time 3 months
n. Heath P, 2021; Shinde V, 2021; Formica N, 2021; Keech C, 2020