Safety of COVID-19 Vaccines: A Nationwide Passive Surveillance in Malaysia

Objective: To characterise the patterns of adverse events following immunization (AEFIs) among individuals vaccinated with COVID-19 vaccines in Malaysia for further risk stratification by gender, age and dose (first/second/booster).Methods: This is an interim analysis of a two-year national passive surveillance for COVID-19 vaccines based on AEFI data obtained from MySejahtera and the national pharmacovigilance database. We analysed all reports/responses received from February to November 2021. We used multiple logistic regression to assess the association between serious reports with gender, age and dose.Findings: In MySejahtera, there were 978,788 responses recorded with an average rate of 18.28 responses per 1,000 doses, totaling 3,470,874 AEFIs. The national pharmacovigilance database received 22,967 reports with 49,946 AEFIs. The overall reporting rate was 0.43 reports per 1,000 doses. Majority of the reports were non-serious (94.1%) AEFIs relating to reactogenicity events. The nature of AEFIs for booster dose was similar to that for the primary doses. The rate for serious reports and adverse events of special interest (AESIs) were low, at an average of 0.03 reports per 1,000 doses and 4.52 reports per million doses, respectively. Serious outcomes were significantly associated with the male gender (Adjusted odds ratio [AOR]: 2.354), elderly aged 60 years and above (AOR: 3.600), and second dose (AOR: 1.338) as well as booster dose (AOR: 0.563).Conclusions: Overall, the reporting trends and the observed characteristics of AEFIs are within expectations. The benefits of COVID-19 vaccines continue to outweigh the known risk. Nevertheless, close monitoring of the vaccines safety is ongoing.Funding Information: The research did not receive any specific grant from funding agencies in the public, commercial, or not for-profit sectors. The authors have no funding to report.Declaration of Interests: We declare no conflict of interest.Ethics Approval Statement: This study received approval from the Medical Research and Ethics Committee [Ref: KKM/NIH/P21- 675(4)]. As this study used secondary data with no patient unique identifier, informed consent was waived.