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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