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 |