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Active Surveillance for Safety Monitoring of XBB.1.5-Containing COVID-19 mRNA Vaccines in Korea
Bomi Park1,2, Hye Ah Lee3, Yeonjae Kim1,2
1COVID-19 Vaccine Safety Research Center, Seoul, Korea.
Abstract:
The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
Insights
The updated XBB.1.5 vaccine for COVID-19 showed short-term safety in Korea, with most adverse events being mild and temporary. This supports its use and potential co-administration with flu vaccines to boost immunity.
Area of Science:
- Immunology
- Public Health
- Vaccinology
Background:
- The Omicron variant and its sub-lineages necessitated updated COVID-19 vaccines.
- The BNT162b2 vaccine was updated to target the Omicron XBB.1.5 variant in September 2023.
- Vaccination campaigns using the updated vaccine commenced in Korea in October 2023.
Purpose of the Study:
- To assess the short-term adverse events following XBB.1.5 vaccination in Korea.
- To monitor health issues, reactions, and healthcare visits post-vaccination.
- To provide data for vaccine safety and public health decision-making.
Main Methods:
- Active nationwide surveillance using daily Short Message Service (SMS) surveys.
- Data collection from October 19, 2023, involving 20,180 respondents.
- Monitoring of health issues, fever, vaccination site reactions, systemic symptoms, daily life impact, and healthcare visits.
Main Results:
- 27.9% of respondents reported health issues after XBB.1.5 vaccination.
- Adverse reactions peaked on day 1 post-vaccination (28.7%).
- Common reactions included vaccination site pain, muscle pain, fatigue, and fever.
Conclusions:
- The XBB.1.5 vaccine demonstrates short-term safety in the Korean population.
- Findings support the co-administration of the XBB.1.5 and influenza vaccines.
- This strategy can help reduce vaccine hesitancy and enhance population immunity.
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