Table 1.
Characteristics of included studies reporting safety of COVID-19 candidate vaccines in clinical trials
| 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 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 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 |
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 |
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 |
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 |
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 |
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 |
USA |
18 years and older | No | Booster dose | 20 (50 μg) | 20 (mRNA-1273) | FDA | |
| CVnCoV/Curevac | Phase 1 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
USA |
18–80 years old | No | 2 doses, 28 days interval | 167 (2.0 mg) | 50 | FDA, CTCAE | |
MenACWY meningococcal group A, C, W, and Y conjugate vaccine; vp viral particles; CTCAE Common Terminology Criteria for Adverse Events