. 2021 Mar 31;11(1):959–982. doi: 10.3126/nje.v11i1.36163

Table 2:

Characteristics of included studies (n=14)-Study outcome, Solicited systemic AEs and Unsolicited AEs

Study	Vaccine	# of doses	Dose schedule (days)	Doses (μg)	Study outcome	Study time point/follow-up	Solicited systemic AEs				Unsolicited adverse reactions
Study	Vaccine	# of doses	Dose schedule (days)	Doses (μg)	Study outcome	Study time point/follow-up	Gp 1	Gp 2	Gp 3	Gp 4	Gp 1	Gp 2	Gp 3	Gp 4
Zhu, et al. [14]	adenovirus type-5 (Ad5)-vectored	(1:1:2)	0	5 × 10¹⁰ 1 × 10¹¹, 1.5 × 10¹¹ viral particles	Safety, tolerability, and immunogenicity	Days 7 and 28	30	30	27	-	-	-	-
Zhu, et al. [15]	adenovirus type-5 (Ad5)-vectored	1	0	1 × 10¹¹, 5 × 10¹⁰ and Placebo	safety and immunogenicity	Days 14 and 28, and month 6	183	96	Placebo	-	19	7	Placebo
Jackson, et al. [16]	mRNA (mRNA-1273)	2	0 and 29	25, 100 and 250	safety and immunogenicity	7 and 14 days after each dose and on days 57, 119, 209, and 394	7	15	14	-	Mild in 69 (21 related to vaccine), Moderate in 19 (12 related to vaccine) and Severe in 2 related to vaccine
Folegatti, et al. [17]	ChAdOx1 nCoV-19 (SARS-CoV-2) vs. MenACWY (Control)	2	0 and 28	5 × 10¹⁰ viral particles	safety and immunogenicity	Days 3, 7, 14, 28, and 56	42	382	meningococcal conjugate vaccine as comparator	-	12	134	meningococcal conjugate vaccine as comparator
Xia, et al. [18]	Inactivated COVID-19 vaccine (Phase-I)	3	0, 28, and 56	2.5 (low), 5 (medium), and 10-μg (high), control	safety and immunogenicity	Days 28, 90, 180, and 360	5	4	6	-	1	0	4
Xia, et al. [18]	Inactivated COVID-19 vaccine (Phase-II)	2	0 and 14 (Gp-1); 0 and 21 (Gp-2)	5-μg (medium) and control	safety and immunogenicity	Days 28, 90, 180, and 360	5	16		-	2	5
Ramasamy, et al. [19]	ChAdOx1 nCoV-19 (SARS-CoV-2) vs. MenACWY (Control)	2	0 and 28	2·2 × 10¹⁰ virus particles and 3·5–6·5 × 10¹⁰ virus	safety and immunogenicity	day 0, 7, 14, and 28	At least one systemic symptom after prime vaccination with the standard dose of ChAdOx1 nCoV-19 by 42 (86%) of 49 participants in the 18–55 years group, 23 (77%) of 30 in the 56–69 group, and 32 (65%) of 49 in the age group of 70 and above.				-
Xia, et al. [20]	BBIBP-CorV	2	0 and 28	2 μg, 4 μg, or 8 μg	safety and immunogenicity	Days 7, 14, 28, 32, and 42	12	11	11	-	-	-	-	-
Xia, et al. [20]	BBIBP-CorV	1/2	8 μg on day 0 or on a two-dose schedule of 4 μg on days 0 and 14, 0 and 21, or 0 and 28	safety and immunogenicity	33/84	19/84	15/84	11/84	-	-	-	-
Anderson, et al. [21]	mRNA (mRNA-1273)	2	1 and 29	25 and 100	safety and immunogenicity	Days 1, 15, 29, 36, 43, and 57.	5 (Dose 1); 7 (Dose 2)	5 (Dose 1); 3 (Dose 2)	3 (Dose 1); 8 (Dose 2)	3 (Dose 1); 7 (Dose 2)	3	14
Keech, et al. [22]	full-length wild-type SARS-CoV-2 spike glycoprotein	2	0 and 21	placebo (group A), 25-μg (group B), 5-μg plus Matrix-M1 (group C), 25-μg + Matrix-M1 (group D), single 25-μg + Matrix-M1 + single dose of placebo (group E)	safety and immunogenicity	Days 1, 7, 21, 28 and 35	Dose 1 Gp-A:30%; Gp-B:32%; Gp-C:69.2%; Gp-D:60%; Gp-E:80.7%. Dose 2 Gp-A:19%; Gp-B:24%; Gp-C:92.3%; Gp-D:75%; Gp-E:15.4%				-
Mulligan, et al. [23]	BNT162 mRNA vaccine	2	0 and 21	10 μg, 30 μg or 100 μg	safety, tolerability and immunogenicity	7, 21, 28 and 35 days	25% (3/12 in 10-μg group) to 50% (6/12 each in 30-μg and 100-μg groups) of individuals who received BNT162b1 and by 11.1% (1/9) of placebo group.				-
Walsh, et al. [24]	BNT162b1 and BNT162b2	2	0 and 21	10 μg, 20 μg, 30 μg, and 100 μg	Safety and Immunogenicity	Day 28 and 35	BNT162b1 18–55 years of age 10 μg (3/12) 20 μg (4/12) 30 μg (6/12) 100 μg (6/12) Placebo (1/12) 65–85 years of age 10 μg (3/12) 20 μg (4/12) 30 μg (2/12) Placebo (1/9) BNT162b2 18–55 years of age 10 μg (2/12) 20 μg (4/12) 30 μg (3/12) 100 μg (0/0) Placebo (1/9) 65–85 years of age 10 μg (0/12) 20 μg (1/12) 30 μg (0/12) Placebo (0/9)				-
Zhang, et al. [25]	CoronaVac (an inactivated vaccine candidate)	2	Either day 0 and day 14, or day 0 and day 28	μg and 6 μg and placebo	safety, tolerability and immunogenicity	Day 14, and 28	Phase 1 Dose 1 3 μg group (6/24); 6 μg group (6/24); Placebo group (2/24). Dose 2 3 μg group (1/24); 6 μg group (5/24); Placebo group (1/24). Phase 2 Dose 1 3 μg group (22/120); 6 μg group (21/120); Placebo group (9/60). Dose 2 3 μg group (7/117); 6 μg group (10/118); Placebo group (2/61).				Phase 1 Dose 1 3 μg group (1/24); 6 μg group (2/24); Placebo group (0/24). Dose 2 3 μg group (0/24); 6 μg group (0/24); Placebo group (0/24). Phase 2 Dose 1 3 μg group (22/120); 6 μg group (21/120); Placebo group (9/60). Dose 2 3 μg group (0/117); 6 μg group (0/118); Placebo group (0/61).
Polack, et al. [26]	mRNA	2	0,21	30	Safety and Immunogenicity	1 week, 1 month, 2 months	Systemic events were reported more often by younger vaccine recipients (16 to 55 years of age) than by older vaccine recipients (age 55 +) in the reactogenicity subset and more often after dose 2 than dose 1. Most common reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger recipients; 51% and 39% among older recipients)				11678/43252 (27%)
Che, et al. [27]	Inactivated vaccine	2	0,14 or 0,28	100 EU or 150 EU	Safety and Immunogenicity	7 days, 28 days, 12 months	0-14 procedure: 7 days after first and second immunizations, mainly slight fatigue and fever in 10%, 13%, and 14.7% of individuals in the medium-dose, high-dose, and placebo groups, respectively 0-28 procedure: 7 days after the first and second immunizations, mainly including slight fatigue and fever, were reported in 13.3%, 8%, and 9.3% of individuals				Overall adverse reaction rates during the 28 days after immunization were 24%, 27.3%, and 17.3% (0, 14 procedure) and 27.3%, 19.3%, and 12% (0, 28 procedure) in the mediumdose, high-dose, and placebo groups, respectively