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Table 1 Characteristics of included studies reporting safety of COVID-19 candidate vaccines in clinical trials

From: Evaluation of the safety profile of COVID-19 vaccines: a rapid review

Platform

Vaccine/manufacturer

Clinical stage

Trial number/study locations

Age range of participants

History of infection

Intervention schedule

Participants included in safety set

Placebo participants

Grading scale

Inactivated

 

BBIBP-CorV/Sinopharm

Phase 2/3

ChiCTR2000032459

NCT04510207

ChiCTR2000034780

Global multi-centers

18 years and older

Yes, 6.7% positive at baseline

2 doses, 21 days interval

13,555 (4 μg)

13,481 (aluminum hydroxide)

CFDA, 2019

WBIP/Sinopharm

Phase 2/3

ChiCTR2000031809

NCT04510207

ChiCTR2000034780

Global

18 years and older

Yes, 6.4% positive at baseline

2 doses, 21 days interval

13,548 (5 μg)

13,481 (aluminum hydroxide)

CFDA, 2019

CoronaVac/SinoVac

Phase 1/2/3

NCT04352608

NCT04383574

NCT04651790

China, Brazil, Chile

3–17 years old/18–59 years old/60 years and older

No

2 doses, 14/28 days interval

6958 (3 μg)

6629 (aluminum hydroxide)

CFDA, 2019

IBMCAMS vaccine/Institute of Medical Biology

Phase 1/2

NCT04470609

NCT04412538

China

18–59 years old

No

2 doses, 14 days interval

174 (150 EU)

99 (aluminum hydroxide)

CFDA, 2019

BBV152 (COVAXIN)/Bharat Biotech

Phase 2

NCT04471519

India

12–65 years old

No

2 doses, 28 days interval

190 (6 μg with Algel-IMDG)

No control groups

FDA and CTCAE

KCONVAC/Shenzhen Kangtai Biological Products Co., Ltd.

Phase 2

ChiCTR2000038804

ChiCTR2000039462

China

18–59 years old

No

2 doses, 28 days interval

100 (5 μg)

50 (aluminum hydroxide)

CFDA, 2019

RNA

 

BNT162b2/Pfizer-BioNTech

Phase 1/2/3

NCT04368728

USA, Argentina, Brazil, Germany, S. Africa, Turkey

12 years and older

Yes

2 doses, 21 days interval

22,752 (30 μg)

22,760 (0.9% sodium chloride)

FDA

mRNA-1273/Moderna

Phase 3

NCT04283461

USA

18–95 years old

Yes

2 doses, 28 days interval

15,208 (100 μg)

15,210 (0.9% saline)

FDA

mRNA-1273.351/Moderna

Phase 2

NCT04405076

USA

18 years and older

No

Booster dose

20 (50 μg)

20 (mRNA-1273)

FDA

CVnCoV/Curevac

Phase 1

NCT04449276

Germany

19–59 years old

No

2 doses, 28 days interval

28 (12 μg)

32 (0.9% saline)

FDA

Non-replicating viral vector

 

Ad5 nCoV/CanSino Biological Inc.

Phase 1- 2

NCT04341389

NCT04313127

China

18–83 years old

No

1 dose

165 (5 × 1010 vp)

126 (vaccine excipients)

CFDA, 2019

ChAdOx1-nCoV (AZD1222/Covishield)/AstraZeneca

Phase 1/2/3

NCT04324606

NCT04400838

NCT04444674

ISRCTN 15281137

ISRCTN89951424

Brazil, South Africa, UK

18 years and older

Yes, 3.0% positive at baseline

2 doses, 28 days interval

12,021 (5 × 1010 vp or 2.2 × 1010 vp)

11,724 (MenACWY† plus saline)

FDA

Gam-COVID-Vac (Sputnik V)/Gamaleya Research Institute

Phase 1/2/3

NCT04436471

NCT04437875

NCT04530396

Russia

18 years and older

No

2 doses, 21 days interval

16,427 (1011 vp for rAd26-S and rAd5-S)

5435 (vaccine buffer composition)

FDA, CTCAE

Ad26.COV2.S/Johnson & Johnson

Phase 1/2a/3

NCT04436276

NCT04505722

Belgium, US, Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa

18–83 years old

Yes, 1.2% positive at baseline

1 dose

21,895 (5 × 1010 vp)

21,888

FDA

Protein subunit

 

NVX-CoV2373/Novavax

Phase 1–2

NCT04368988

USA, Australia

18–84 years old

No

2 doses, 21 days interval

257 (5μg + 50 μg Matrix-M1)

255 (0.9% saline)

FDA

SCB-2019/Clover Biopharmaceuticals Inc.

Phase 1

NCT04405908

Australia

18–74 years old

No

2 doses, 21 days interval

16 (30 μg SCB-2019 + CpG/Alum)

30 (0.9% saline)

FDA

ZF2001/Anhui Zhifei Longcom Biopharmaceutical

Phase 1/2

NCT04445194

NCT04466085

China

20–59 years old

No

3 doses, 30 days interval

170 (25 μg)

160 (aluminum hydroxide)

CFDA, 2019

EpiVacCorona/Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

Phase 1/2

NCT04527575

Russia

18–60 years old

No

2 doses, 21 days interval

57 (225 ± 45 μg)

43 (0.9% saline)

NA

Virus-like particle

 

CoVLP/Medicago Inc.

Phase 1

NCT04450004

Canada

19–49 years old

No

2 doses, 21 days interval

20 (3.75 μg + AS03)

No control group

FDA

DNA

 

INO-4800/Inovio Pharmaceuticals

Phase 1–2

NCT04336410

NCT04642638

USA

18–80 years old

No

2 doses, 28 days interval

167 (2.0 mg)

50

FDA, CTCAE

  1. MenACWY meningococcal group A, C, W, and Y conjugate vaccine; vp viral particles; CTCAE Common Terminology Criteria for Adverse Events