Guideline Development Tool

Author(s): H. Bergman, K. Probyn

Question: CoronaVac compared to Placebo for vaccination against COVID-19 ^a

Setting: Worldwide

Bibliography: https://covid-nma.com

Certainty assessment	№ of patients	Effect	Certainty	Importance
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-2^c
2 ^d	randomised trials	not serious ^b	serious ^e	serious ^f	not serious	none	94/11512	200/8340	Rate ratio 0.30 (0.10 to 0.88)	-- per 1000 patient(s) per years (from -- to --)	⨁⨁◯◯ LOW ^b
Severe or critical disease due to COVID-19^c
2 ^d	randomised trials	not serious ^b	not serious	serious ^f	serious ^g	none	0/11512	7/5217	Rate ratio 0.000 (0.000 to 0.831)	-- per 1000 patient(s) per years (from -- to --)	⨁⨁◯◯ LOW
All-cause mortality ^h
2 ^d	randomised trials	not serious	not serious	serious ^f	very serious ⁱ	none	1/12841 (0.0%)	2/9769 (0.0%)	RR 0.50 (0.05 to 5.52)	10 fewer per 100,000 (from 19 fewer to 93 more)	⨁◯◯◯ VERY LOW
Any adverse events^j
4 ^k	randomised trials	not serious	not serious	serious ^f	not serious	none	6427/13117 (49.0%)	5293/9919 (53.4%)	RR 1.09 (1.07 to 1.11)	4,803 more per 100,000 (from 3,735 more to 5,870 more)	⨁⨁⨁◯ MODERATE
Serious adverse events^h
2 ^d	randomised trials	not serious	not serious	serious ^f	very serious ⁱ	none	39/12848 (0.3%)	36/9762 (0.4%)	RR 0.99 (0.63 to 1.55)	4 fewer per 100,000 (from 136 fewer to 203 more)	⨁◯◯◯ VERY LOW

Certainty assessment

№ of patients

Effect

Certainty

Importance

№ of studies

Study design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerations

CoronaVac

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-2^c

2 ^d

randomised trials

not serious ^b

serious ^e

serious ^f

not serious

none

94/11512

200/8340

Rate ratio 0.30
(0.10 to 0.88)

-- per 1000 patient(s) per years
(from -- to --)

⨁⨁◯◯
LOW ^b

Severe or critical disease due to COVID-19^c

2 ^d

randomised trials

not serious ^b

not serious

serious ^f

serious ^g

none

0/11512

7/5217

Rate ratio 0.000
(0.000 to 0.831)

-- per 1000 patient(s) per years
(from -- to --)

⨁⨁◯◯
LOW

All-cause mortality ^h

2 ^d

randomised trials

not serious

serious ^f

very serious ⁱ

none

1/12841 (0.0%)

2/9769 (0.0%)

RR 0.50
(0.05 to 5.52)

10 fewer per 100,000
(from 19 fewer to 93 more)

⨁◯◯◯
VERY LOW

Any adverse events^j

4 ^k

randomised trials

not serious

serious ^f

not serious

none

6427/13117 (49.0%)

5293/9919 (53.4%)

RR 1.09
(1.07 to 1.11)

4,803 more per 100,000
(from 3,735 more to 5,870 more)

⨁⨁⨁◯
MODERATE

Serious adverse events^h

2 ^d

randomised trials

not serious

serious ^f

very serious ⁱ

none

39/12848 (0.3%)

36/9762 (0.4%)

RR 0.99
(0.63 to 1.55)

4 fewer per 100,000
(from 136 fewer to 203 more)

⨁◯◯◯
VERY LOW

a. Last updated: 25 July 2021

b. Despite some concerns with deviations from intervention, not downgraded for risk of bias.

c. Measured from 14 days after the 2nd dose up to median 2 months follow-up

d. Palacios R, PROFISCOV, 2021; Tanriover M, 2021

e. Inconsistency downgraded by 1 level: I²=86.7%

f. Indirectness downgraded by one level: data are from interim analyses of the trials, with a short duration of follow-up. Estimates may change over a longer duration of follow-up.

g. Imprecision downgraded by 1 level: due to low number of events and/or participants

h. Median follow-up: 2 months and 3 months

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: 1.38, 1.84, 2 and 3 months

k. Palacios R, PROFISCOV, 2021; Tanriover M, 2021; Wu Z, 2020; Zhang Y, 2020 (1); Zhang Y, 2020 (2)

Explanations