Table 2.
Safety evaluation in humans conducted in randomized clinical trials by applicants on the three vaccines under consideration.
| Pfizer BioNTech | Moderna | Astra-Zeneca | |
|---|---|---|---|
| Dose | 30 μg of mRNA | 100 μg of mRNA | 5 × 1010 vp |
| x 2 doses | x 2 doses | x 2 doses | |
| No. subjects | 21,720 (vaccine group) | 15,185 (vaccine group) | 12,021 (vaccine group) |
| 21,728 (placebo) | 15.166 (placebo) | 11,724 (placebo) | |
| Age groups | 16-55 and >55 years | ≥18 years | 18-55, 56-69, ≥70 year |
| Follow-up period | ≥ 2 months (50.6% of individuals) | 63 days | 55.6 days |
| (median after 2nd dose) | (median, 50.6% after 2nd dose) | (median after 2nd dose) | (median after 2nd dose) |
| Local effects | Injection site pain (∼80%) | Injection site pain (83-88%) | Tenderness (75%) |
| (Reactogenicity in the vaccine group) | Redness and swelling (<10%) | Erythema (<9%) | Pain (54%) |
| Lymphadenopathy (0.4%) | Swelling/induration (<12%) | Redness (<3%) | |
| Lymphadenopathy (<14%) | Warmth (<18%) | ||
| Itch (<7%) | |||
| Swelling or induration (<3%) | |||
| Lymphadenopathy (0.3%) | |||
| Onset after vaccination | 1-3 days | 1-2 days | <7 days |
| Duration | 1-2 days (median) | 1-3 days | 3.3 days (mean) |
| Local effects persisting > 7 days | 3.8% (vaccine group) | ||
| 1.3% (placebo) | |||
| Lymphadenopathy, pain | |||
| Systemic reactions | Vaccine group (84.1%) | Vaccine group (86%) | |
| (overall data) | Placebo group (53.5%) | Placebo group (71.7%) | |
| (after any dose) | (for any local and systemic adverse events, after any dose) | ||
| Systemic adverse reactions | Fatigue (<60%) | Fatigue (<66%) | Fatigue (62%) |
| (Reactogenicity in the vaccine group) | Headache (<50%) | Headache (<59%) | Headache (57%) |
| Myalgia and chills (30%) | Myalgia (<58%) | Muscle pain (49%) | |
| Arthralgia (20%) | Arthragia (<43%) | ||
| Fever (≤16%) | Fever (<16%) | Feverishness (9%) | |
| Nausea (0.8%) | Nausea/vomiting (<19%) | Nausea (22%) and vomiting (2%) | |
| Chills (<45%) | Malaise (44%) | ||
| Onset after vaccination | 7 days after 1st or 2nd dose | 1-2 days after any dose | ≤ 7 days of any dose |
| Duration | 1-2 days (median) | 2.8 days (mean) | |
| Any adverse events (overall data) | Vaccine group (26.7%) | ||
| Placebo group (12.2%) | |||
| Adverse events (imbalanced) | Appendicitis (8/4, vaccine/placebo) | Hepatobiliary disorders (15/3, vaccine/placebo) (mainly cholelithiasis and cholecystitis) | Nervous System Disorders (headache, lethargy, migraines, somnolence, dizziness) |
| Biliary events (14/5, vaccine/placebo) | |||
| None vaccine-related | None vaccine-related (chance) |
|
|
| Serious adverse events (overall data) | Vaccine group (0.6%, 56 cases) | Vaccine group (16 cases) | Vaccine group (0.8 %) |
| Placebo group (0.6%, 53 cases) | Placebo group (10 cases) | Placebo group (1.1 %) | |
| Serious adverse events | Bell’s paralysis | Bell’s paralysis | Bell’s paralysis |
|
|
|
|
| Cerebrovascular accidents | Paraesthesia, hypoesthesia and muscular weakness (not imbalanced): | ||
| Embolic strokes | |||
| Transient ischaemic attack | |||
Deep vein thrombosis
|
|
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| Anaphylaxis | Vaccine group (n = 2) | Vaccine group (n = 1) | Vaccine group (n = 1) (not treatment-related) |
| Placebo group (n = 1) (not treatment-related) | Placebo group (n = 1) (without temporal relation with injection) | ||
| Deaths | Vaccine group (n = 2) | Vaccine group (n = 6) | Vaccine group (n = 2) |
| Placebo group (n = 4) | Placebo group (n = 7) | Placebo group (n = 4) | |
| (none treatment-related) | (none treatment-related) | (none treatment-related) | |
| Ongoing pivotal studies (long-term events) | 2-year follow-up | 2-year follow-up | 1-year follow-up |