Journal Article

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study

Lim, Ming Tsuey, Peariasamy, Kalaiarasu M, King, Teck Long, Ramli, Azuana, Saharudin, Siti Nurhafizah, Ab Rahman, Norazida, Ayub, Nor Aliya, Sevalingam, Raj Kumar, Bahari, Rashidah, Mahmud, Fatihah, Anak Jam, Emelyne Bani, Ibrahim, Nor Nadziroh, Lee, Fei Yee, Lee, Sing Chet, Sivasampu, Sheamini

2022

Overview

Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell’s Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. There was no increase in the risk for myocarditis/pericarditis, Bell’s Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adverse events / Adverse events of special interest / Allergy and Immunology / Arrhythmia / Bell Palsy - chemically induced / Bell Palsy - epidemiology / Bell's palsy / BNT162 Vaccine / Cerebral infarction / ChAdOx1 nCoV-19 / confidence interval / Confidence intervals / Coronaviruses / COVID-19 / COVID-19 - epidemiology / COVID-19 - prevention & control / COVID-19 infection / COVID-19 vaccines / COVID-19 Vaccines - adverse effects / Health surveillance / Heart diseases / Hospitals / Humans / Immunization / Malaysia / Malaysia - epidemiology / monitoring / Myocardial infarction / Myocardial Infarction - chemically induced / Myocardial Infarction - epidemiology / Myocarditis / Myocarditis - chemically induced / Myocarditis - epidemiology / Paralysis / Pericarditis / Pericarditis - chemically induced / Pericarditis - epidemiology / Pharmacovigilance / Population / risk / Risk analysis / Risk assessment / risk-benefit analysis / Safety / Seizures / Seizures - chemically induced / Self-controlled case series / Statistical analysis / Stroke - chemically induced / Stroke - epidemiology / Surveillance / Thrombocytopenia / Thrombocytopenia - chemically induced / Thrombocytopenia - epidemiology / Thromboembolism / vaccination / Vaccines / Vaccines, Inactivated / Venous Thromboembolism - chemically induced / Venous Thromboembolism - epidemiology