Vaccine safety and reactogenicity
thrombosis, thrombocytopenia, myocarditis, SAEs, RBD, rheumatoid
THROMBOSIS, ADVERSE EVENTS, ADVERSE EVENT, THROMBOCYTOPENIA, MYOCARDITIS, PERICARDITIS
No vaccine-related SAEs occurred, nor any adverse events of special interest (e.g. myocarditis, pericarditis, thrombosis, thrombocytopenia, Guillain-Barré syndrome) or vaccine related medically-attended AEs. There were no biochemical, serologic, or haematologic safety signals following vaccination. No participant had a rheumatoid factor titre >40IU/mL (pre-specified laboratory abnormality of special interest). Detailed analyses of anti-Fc antibodies demonstrated no detectable signal in protein RBD recipients compared to placebo and mRNA recipients (The Protein-RBD vaccine reactogenicity profile was mild (no Grade-3 reactions). The mRNA-RBD vaccine was more reactogenic in terms of transient Grade-3 reactions at the intermediate (1 subject) and higher dose level (2 participants) (Adverse events.