Increased Risk of 'Acute Myocarditis' After Pfizer and Moderna Vaccination
The Korean Academy of Medical Sciences Announces Research Results of the COVID-19 Vaccine Safety Committee
[Asia Economy Reporter Ki Ha-young]Although no increase in mortality rate due to COVID-19 vaccination has been confirmed, a study has found sufficient evidence to recognize causality between acute myocarditis and vaccination with Pfizer and Moderna vaccines.
The National Academy of Medicine of Korea disclosed these research results on the afternoon of the 4th at the 2nd forum of the COVID-19 Vaccine Safety Committee. Previously, in November last year, the Academy independently launched the COVID-19 Vaccine Safety Committee. This was in response to a request from the Korea Disease Control and Prevention Agency (KDCA) for related research to establish a scientific basis for evaluating causality of adverse reactions following COVID-19 vaccination.
According to the study, evidence supporting causality was confirmed between acute myocarditis and messenger RNA (mRNA) vaccines such as Pfizer and Moderna, whereas there was insufficient evidence to recognize causality for acute pericarditis to date.
Without considering vaccination, it was expected that approximately 0.043 cases of acute myocarditis and 0.17 cases of acute pericarditis per 100,000 population would occur in the entire domestic population over six months from March to August 2021. However, the actual observed incidence rates during this period were 0.367 cases of acute myocarditis and 0.228 cases of acute pericarditis, which are 8.5 times and 1.3 times the expected values, respectively.
The incidence rate of acute myocarditis after one dose of vaccine increased statistically significantly by 3.57 times for the Pfizer vaccine and 5.67 times for the Moderna vaccine. For acute pericarditis, the incidence increased by 9.6 times after Pfizer vaccination and 7 times after Moderna vaccination. No significant increase in acute myocarditis incidence was observed with AstraZeneca and Janssen (Johnson & Johnson) vaccines.
Although the incidence of acute myocardial infarction also increased statistically significantly after COVID-19 vaccination, the researchers noted that COVID-19 infection itself is a risk factor for acute myocardial infarction. Regarding stroke, the researchers explained that current studies have not shown a clear association with vaccination, indicating that further research is needed. However, these results are interim findings for the above diseases, and follow-up studies will continue.
Park Byung-joo, Chair of the COVID-19 Vaccine Safety Committee, stated, "Please understand that this causality evaluation study was conducted on a population basis and is not an administrative standard for recognizing causality of adverse reactions in individuals," and added, "We deeply empathize with the pain and frustration of those suffering from adverse reactions after vaccination and offer our sincere condolences to the deceased and their families."
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The KDCA commented on the study results, saying, "We plan to actively review and accept the opinions of the COVID-19 Vaccine Safety Committee," and added, "We will comprehensively review the causality evaluation results and vaccination implementation standards through the Vaccine Injury Compensation Expert Committee and the Vaccination Expert Committee, and provide guidance to the public via briefings as soon as possible."
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