Objectives To evaluate the safety and benefit-risk profile of mRNA-1273 following the vaccine's authorization and the administration of over one million doses in Indonesia. Design A retrospective analytical study was conducted to assess adverse events following immunization (AEFI) within 28 days after the latest dose of primary vaccine of mRNA-1273 COVID-19 vaccine. Data collection was conducted on November 3rd - December 31st, 2022 in 18 public health centers and one hospital from five regions in Jakarta, Indonesia. All of the participants' candidates will be contacted by trained interviewers via telephone to answer the questionnaire. Results A total of 1284 subjects (response rate = 31.05%) were enrolled and interviewed, with 13 drop out subjects. The most common solicited local reactions were local pain, erythema and swelling, meanwhile for systemic systemic reaction was fever. Most solicited and systemic local reactions showed an increase in reported events on days 1–3 after vaccination and rapidly decreasing afterwards. After dose 2 of mRNA-1273 COVID-19 vaccine, local pain, was reported more frequently in females and younger age. There were four serious adverse events (SAE) reported in this study which classified as coincidence. Conclusion mRNA-1273 COVID-19 vaccination in Indonesia is safe.
Medise et al. (2026) studied this question.