Nationwide safety surveillance of COVID-19 mRNA vaccines following primary series and first booster vaccination in Singapore
Nationwide safety surveillance of COVID-19 mRNA vaccines following primary series and first booster vaccination in Singapore
Blog Article
Background: The real-world safety profile of COVID-19 mRNA vaccines remains incompletely elucidated.Methods: We performed a nationwide post-market safety surveillance analysis in Singapore, on vacinees aged 5 years and older, through mid-September 2022.Observed-over-expected (O/E) analyses were performed to identify potential safety signals among eight shortlisted adverse events of special interest (AESIs): strokes, cerebral venous thrombosis (CVT), acute myocardial infarction, myocarditis/pericarditis, pulmonary embolism, immune thrombocytopenia, convulsions and appendicitis.Self-controlled case series abc material analyses (SCCS) were performed to validate signals of concern, occurring within 42 days of vaccination.Findings: Elevated risks were observed on O/E analyses for the following AESIs: myocarditis/pericarditis, [rate ratio (RR): 3.
66, 95 % confidence interval (95 % CI): 2.71 to 4.94], appendicitis [RR: 1.14 (1.02 to 1.
27)] and CVT [RR: 2.11 (1.18 to 3.77)].SCCS analyses generated corroborative findings: myocarditis/pericarditis, [relative incidence (RI): 6.
96 (3.95 to 12.27) at 1 to 7 days post-dose 2], CVT [RI: 4.30 (1.30 to 14.
20) at 22 to 42 days post-dose 1] and appendicitis [RI: 1.31 (1.03 to 1.67) at 1 to 7 days post-dose 1].Booster dose 1 continued to be associated with higher rates of myocarditis/pericarditis on O/E analysis [RR: 2.
30, (1.39 to 3.80) and 1.69, (1.11 to 2.
59)] here at 21- and 42-days post-booster dose 1, respectively.Males aged 12 to 17 exhibited highest risks of both myocarditis/pericarditis [RI: 6.31 (1.36 to 29.3)] and appendicitis [RI: 2.
01 (1.12 to 3.64)] after primary vaccination.Similarly, CVT was also predominantly observed in males aged above 50 (11 out of 16 cases), within 42-days of vaccination.Interpretation: Our data suggest that myocarditis/pericarditis, appendicitis and CVT are associated with primary vaccination using COVID-19 mRNA vaccines.
Males at specific ages exhibit higher risks for all three AEs identified.The risk of myocarditis/pericarditis continues to be elevated after booster dose 1.