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HOME > Osong Public Health Res Perspect > Volume 15(2); 2024 > Article
Editorial
Peacetime preparedness for the vaccine adverse event
Jong-Koo Leeorcid
Osong Public Health and Research Perspectives 2024;15(2):95-96.
DOI: https://doi.org/10.24171/j.phrp.2024.0113
Published online: April 30, 2024

National Academy of Medicine of Korea, Seoul, Republic of Korea

Corresponding author: Jong-Koo Lee National Academy of Medicine of Korea, 51 Seochojungang-ro, Seocho-gu, Seoul 06654, Republic of Korea E-mail: docmohw@snu.ac.kr
• Received: April 24, 2024   • Accepted: April 25, 2024

© 2024 Korea Disease Control and Prevention Agency.

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Globally, we are largely moving past coronavirus disease 2019 (COVID-19) and returning to normalcy. The government of the Republic of Korea plans to lower the COVID-19 alert level to the least severe tier, “interest,” starting May 1, 2024 [1]. The recommended period of isolation for Covid-19 patients will be shortened from the current five days to patients isolating for one extra day after symptoms have disappeared, and mask-wearing in medical institutions will become voluntary, similar to the protocols for seasonal influenza. Additionally, the 2023−2024 seasonal vaccination campaign will conclude. This fall, the 2024−2025 seasonal vaccination schedule is set to be offered free of charge and will continue to prioritize high-risk groups, including those for influenza. However, it will be necessary to implement pre-emptive measures for respiratory syncytial virus vaccinations, as recommended for high-risk groups in some countries.
The return to everyday life represents a period of calm before the next pandemic, and our use of this time to prepare for future challenges is clearly informed by past experiences. Firstly, the government has committed to improving communication. However, the most crucial strategy for preparing and responding to the next outbreak is vaccination. Nevertheless, due to legislative shortcomings, policies concerning compensation for vaccine-related damages are still being developed.
We have published 2 research papers that investigate adverse reactions to COVID-19 vaccinations in the Republic of Korea. The first paper primarily discusses the research methodology used to study vaccination adverse reactions, titled "A Framework for Nationwide COVID-19 Vaccine Safety Research in the Republic of Korea" [2]. The second paper summarizes the research findings published in this issue [3]. The authors calculated the expected versus observed occurrence ratios for 29 diseases, and validate mechanistic evidence and draw conclusions about causality. The timing of these papers, coinciding with the Global Vaccine Data Network 24 symposium, is particularly opportune, especially given that the United States (US) National Academy of Medicine has also released results on the adverse effects of severe acute respiratory syndrome coronavirus 2 vaccination [4].
Over the past 3 years, the Korea Disease Control and Prevention Agency has entrusted the National Academy of Medicine of Korea with the rapid identification of causal links related to vaccinations. Typically, the evidence is classified into 4 levels: establishes a causal relationship, favors acceptance of a causal relationship, is inadequate to accept or reject a causal relationship, and favors rejection of a causal relationship. However, conditions such as pericarditis, Guillain-Barré syndrome, Bell's palsy, and some other diseases exhibit some differences between the Republic of Korea and the US, necessitating further discussion and research.
To effectively respond to the potential Disease X, the global community is striving to develop new mRNA vaccines within 100 days, targeting 10 viral families identified by the US National Institute of Health and 25 viral families identified by the Coalition for Epidemic Preparedness Innovations. However, it is even more crucial to evaluate the efficacy and safety of these vaccines. For example, the US Food and Drug Administration withdrew the emergency use authorization for Ad26.COV2.S because it did not update its approval to reflect adaptations needed for the evolving virus [5]. Therefore, ongoing research and the adaptation of vaccines to accommodate viral changes are imperative. During peacetime, it is essential to promptly address issues related to adverse vaccine reactions and to reduce vaccine hesitancy. Several measures are necessary to achieve this.
First, to prepare for emergency vaccinations, we must strengthen both active and passive surveillance networks (pharmacovigilance). This involves establishing investigative methodologies, identifying critical information, and determining methods for minimal data set collection. To achieve this, specific centers should be designated for data collection, and relevant personnel must be trained.
Second, the role of the rapid response team for severe adverse reactions should extend beyond merely identifying causal relationships in individual cases. It should also address recurring incidents through rapid cycle analysis. Establishing a real-time insurance claim platform to confirm associations should be a fundamental part of the operational system. This platform should include investigations into deaths as part of broader epidemiological studies.
Third, addressing vaccine-related injuries and generating scientific evidence are distinct tasks that can be approached in 2 different ways. Some regions, such as Europe and Asia (including Germany, Japan, and Taiwan), treat vaccine injuries as a matter of social solidarity, offering compensation even without definitive causal evidence. In contrast, the US distinguishes between its emergency response compensation (Countermeasures Injury Compensation Program) and its general vaccination compensation (Vaccine Injury Compensation Program), employing a more stringent compensation system. Consequently, the Republic of Korea should weigh the advantages and disadvantages of both models [4]. Although current public sentiment leans towards the former, further legislative improvements are necessary.
In conclusion, ongoing investment in scientific research to address vaccine injuries is crucial for maintaining communication with the public. Additionally, nurturing and sustaining personnel and organizations is essential to achieving our goals. We must avoid prematurely reducing budgets and organizations related to disease management as diseases are being eradicated.

Ethics Approval

Not applicable.

Conflicts of Interest

Jong-Koo Lee has been the editor-in-chief of Osong Public Health and Research Perspectives since October 2021.

Funding

None.

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