Reporting of harmsa | Total | GlaxoSmithKline | Merck Sharp and Dohme | |||
---|---|---|---|---|---|---|
Studies (N = 24) | Participants (N = 96,855)a | Studies (N = 17) | Participants (N = 66,235)a | Studies (N = 7) | Participants (N = 30,620) | |
Fatal harms | ||||||
Reported for the whole study period | 23 | 64,679 (67%) | 16 | 34,059 (51%) | 7 | 30,620 (100%) |
Reported for the whole study period for someb participants | 1 | 32,176 (33%) | 1 | 32,176 (49%) | 0 | 0 (0%) |
Serious harmsc | ||||||
Reported for the whole study period | 14 | 28,245 (30%) | 14 | 28,245 (42%) | 0 | 0 (0%) |
No breakdown into MedDRA-preferred terms | 3 (21%) | 2586 (9%) | 3 (21%) | 2586 (9%) | 0 (0%) | 0 (0%) |
Reported 0 to 14 days post-vaccination | 7 | 30,620 (31%) | 0 | 0 (0%) | 7 | 30,620 (100%) |
Reported for the 7-month vaccination period | 2 | 5814 (6%) | 2 | 5814 (9%) | 0 | 0 (0%) |
Reported for a subset or the serious harms judged vaccine-related by the trial investigatorsb | 1 | 32,176 (33%) | 1 | 32,176 (49%) | 0 | 0 (0%) |
New onset diseasesd | ||||||
Reported as ‘medically significant conditions’ for the whole study period | 15 | 65,741 (68%) | 15 | 65,741 (99%) | 0 | 0 (0%) |
No breakdown into MedDRA-preferred terms | 2 (13%) | 33,216 (51%) | 2 (13%) | 33,216 (51%) | 0 (0%) | 0 (0%) |
Reported as ‘new medical history’ for the whole study period | 7 | 30,620 (31%) | 0 | 0 (0%) | 7 | 30,620 (100%) |
Not reported/included in clinical study report | 2 | 494 (1%) | 2 | 494 (1%) | 0 | 0 (0%) |
General harmse | ||||||
Reported as ‘solicited’ and ‘unsolicited’ general harms 7 and 30 days post-vaccination | 14 | 64,010 (66%) | 14 | 64,010 (96%) | 0 | 0 (0%) |
Reported for a subset of participantsf | 2 (14%) | 7791/50,820 | 2 (14%) | 7791/50,820 | 0 (0%) | 0 (0%) |
Reported as ‘systemic adverse events’ 14 days post-vaccination | 7 | 30,620 (31%) | 0 | 0 (0%) | 7 | 30,620 (100%) |
No breakdown into MedDRA-preferred terms | 3 (43%) | 21,441 (70%) | 0 (0%) | 0 (0%) | 3 (43%) | 21,441 (70%) |
Not reported/included in clinical study report | 3 | 2225 (3%) | 3 | 2225 (4%) | 0 | 0 (0%) |