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Safety profile following mRNA-1273 COVID-19 primary vaccination in healthy adults in Indonesia
Bernie Endyarni Medise1,2, Nastiti Kaswandani1,2, Nina Dwi Putri1,2
1National Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Jakarta, Indonesia.
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.
Insights
The mRNA-1273 COVID-19 vaccine demonstrates a favorable safety profile in Indonesia. Post-vaccination reactions were generally mild and transient, with no significant safety concerns identified.
Area of Science:
- Vaccinology
- Immunology
- Public Health
Background:
- The mRNA-1273 COVID-19 vaccine (Moderna) has been widely administered globally.
- Assessing vaccine safety and benefit-risk profiles in real-world settings is crucial post-authorization.
Purpose of the Study:
- To evaluate the safety and benefit-risk profile of the mRNA-1273 vaccine in Indonesia.
- To assess adverse events following immunization (AEFI) after primary vaccination with mRNA-1273.
Main Methods:
- Retrospective analytical study design.
- Data collected via telephone interviews from 1284 subjects in Jakarta, Indonesia.
- AEFI assessed within 28 days post-vaccination.
Main Results:
- Common reactions included local pain, erythema, swelling, and fever, primarily occurring within 1-3 days post-vaccination.
- Local pain was more frequent in females and younger individuals after the second dose.
- Four serious adverse events (SAEs) were reported and classified as coincidental.
Conclusions:
- mRNA-1273 COVID-19 vaccination in Indonesia is safe.
- The vaccine exhibits an acceptable safety profile with manageable adverse events.
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