ChAdOx1 nCoV-19 [29] |
Viral vector |
2/3 |
23848 |
United Kingdom, Brazil, and South Africa |
3.4 months |
Occurrence of virologically-confirmed, symptomatic COVID-19. |
30 (0.5%) cases among 5807 participants in the vaccine arm and 101 (1.7%) cases among 5829 participants in the control group resulting in vaccine efficacy of 70.4%. |
Serious adverse events and adverse events of special interest balanced across the study arms. |
No cases of severe COVID-19 in the ChAdOx1 vaccine group. In the control group there were 10 cases hospitalized for COVID-19; 2 were classified as severe COVID-19, including one death. |
A case of transverse myelitis was reported 14 days after ChAdOx1 nCoV-19 booster vaccination as being possibly related to vaccination, with the independent neurological committee considering the most likely diagnosis to be of an idiopathic, short segment, spinal cord demyelination. |
mRNA- BNT162b2 [23] |
RNA |
2/3 |
43548 |
152 sites worldwide (mostly United States) |
2 months |
Occurrence of COVID-19 starting 7 days after the second injection of the vaccine |
8 cases (0.04%) of Covid-19 among participants assigned to receive BNT162b2 and 162 (0.86%) cases among those assigned to placebo resulting in vaccine efficacy of 95%. |
More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). |
1 case of severe COVID-19 in the BNT162b2 vaccine group. In the control group there were 9 cases of severe COVID-19. |
BNT162b2 recipients reported more local reactions than placebo recipients (mild-to-moderate pain at the injection site was the most commonly reported local reaction, with less than 1% of participants reporting severe pain). |
Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). |
mRNA-1273 [24] |
RNA |
3 |
30420 |
United States |
64 days |
Occurrence of COVID-19 starting 14 days after the second injection of the vaccine |
11 cases in the vaccine group (3.3 per 1000 person-years) and 185 cases in the placebo group (56.5 per 1000 person-years), indicating 94.1% efficacy of the mRNA-1273 vaccine. |
The frequency of medically attended adverse events (9.7% vs. 9.0%) and serious adverse events (0.6% in both groups) were similar. |
No cases of severe COVID-19 in the vaccine group. In the control group there were 30 cases of severe COVID-19, including one death. |
Adverse events at the injection site occurred more frequently in the mRNA-1273 group than in the placebo group after both the first dose (84.2%, vs. 19.8%) and the second dose (88.6%, vs. 18.8%). However, these events were of low severity. |
Gam-COVID-Vac [28] |
Viral vector |
3 |
21977 |
Russia |
48 days |
Occurrence of PCR-confirmed COVID-19 starting 21 days after the first dose. |
16 (0.1%) cases among 14.964 participants in the vaccine arm and 62 (1.3%) cases among 4902 participants in the control group resulting in vaccine efficacy of 91.6%. |
The most common adverse events were flu-like illness, injection site reactions, headache, and asthenia. 30 adverse events were grade 3 (0.38%). None of the serious adverse events were considered associated with vaccination. |
No cases of moderate or severe COVID-19 in the Gam-COVID-Vac vaccine group. In the control group there were 20 cases of moderate or severe COVID-19. |