Nikhil Prasad Fact checked by:Thailand Medical News Team Sep 01, 2024 2 weeks, 22 hours, 35 minutes ago
Medical News: Based on a past study finding, Oregon-based researchers have raised concerns regarding the potential cardiac risks associated with the JYNNEOS vaccine 9made by Danish company - Bavarian Nordic, which is currently being advocated and promoted for use to prevent monkeypox (Mpox). This warning comes after a comprehensive study was conducted by experts from the Department of Infectious Diseases, the Department of Analytics, and the Department of Pediatrics at Kaiser Permanente Northwest, Portland, Oregon-USA. The researchers aimed to assess the incidence of cardiac adverse events of special interest (AESI) following the administration of the JYNNEOS vaccine (A MVA-BN vaccine) during the ongoing public health emergency.
Oregon doctors warn of potential cardiac issues linked to JYNNEOS Mpox vaccine
The JYNNEOS vaccine, approved by the U.S. Food and Drug Administration (FDA), is a key tool in combating smallpox and monkeypox outbreaks. However, safety data from the FDA has flagged potential cardiac issues post-vaccination.
https://www.fda.gov/media/131078/download
This Medical News report delves into the findings of the study and explores the implications for public health, particularly for individuals with pre-existing heart conditions.
It should be noted that
Thailand Medical News had covered certain other studies that also warned about the effectiveness of the current Mpox vaccines and its possible adverse effects.
https://www.thailandmedical.news/news/chinese-researchers-warn-that-current-vaccines-are-inefficient-in-protecting-against-emerging-mpox-virus
https://www.thailandmedical.news/news/norwegian-doctors-warn-that-mpox-vaccines-can-cause-generalized-pustular-psoriasis-in-some
Study Methodology and Patient Demographics
The study was a retrospective cohort analysis that included 2,126 patients aged 12 and above, all of whom received at least one dose of the JYNNEOS vaccine between July 14, 2022, and October 10, 2022. The researchers examined electronic health records (EHR) from the Kaiser Permanente Northwest database, looking for signs of cardiac events, including elevated troponin levels, myocarditis, pericarditis, and other related conditions within 21 days post-vaccination.
The patient cohort primarily consisted of 1,811 males (85.2%), 290 females (13.6%), and 25 non-binary individuals (1.2%). The ages of the participants ranged from 12 to 82 years. Importantly, 1,077 patients received two doses of the vaccine, while a smaller group of 16 individuals received three doses.
Key Findings: Incidence of Cardiac Adverse Events
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The researchers identified 24 possible cases of cardiac AESI using diagnostic codes and troponin values from patient records. However, after detailed physician review, only 10 of these cases were confirmed as cardiac AESI, yielding an incidence rate of 3.1 per 1,000 doses administered (with a 95% confidence interval of 1.5 to 5.7). This suggests that while the occurrence of such events is relatively rare, it is significant enough to warrant caution, especially in patients with pre-existing cardiac conditions.
Interestingly, none of the confirmed cardiac events could be directly attributed to the JYNNEOS vaccine itself. The study revealed that most of these events had alternative explanations. For instance, several cases were associated with underlying health conditions, such as obesity, hypertension, or pre-existing arrhythmias. Additionally, seven out of the ten patients experienced symptoms that were mild enough to be managed on an outpatient basis, with no hospitalizations or severe outcomes reported.
Understanding the Cardiac Risks
The U.S. FDA's safety data on the JYNNEOS vaccine had previously indicated potential cardiac risks, particularly in individuals with underlying heart disease or multiple cardiac risk factors. The Advisory Committee on Immunization Practices (ACIP) has also highlighted the theoretical risk of myopericarditis - a condition involving inflammation of the heart muscle and surrounding pericardium - following vaccination.
Despite these concerns, the study's findings provide some reassurance. Although cardiac AESI were identified, the lack of a direct link to the vaccine suggests that the overall risk remains low. This is particularly relevant for healthcare providers who are advising patients with pre-existing cardiac conditions. The study offers timely data to support informed decision-making during the ongoing public health emergency.
Implications for Public Health and Future Research
The results of this study are crucial for public health messaging, particularly in the context of widespread vaccination efforts. While the JYNNEOS vaccine is an essential tool in controlling the spread of monkeypox, it is vital to continue monitoring its safety profile, especially as more data becomes available.
Future research should focus on examining the incidence of cardiac AESI by dose number and route of administration (subcutaneous vs. intradermal). Additionally, the potential impact of pre-existing conditions on the rate of adverse events should be explored further. Such studies will help refine the risk-benefit analysis for the JYNNEOS vaccine, particularly in vulnerable populations.
Conclusion: Navigating Vaccine Safety
In conclusion, the study conducted by researchers at Kaiser Permanente Northwest highlights the importance of ongoing vigilance in monitoring vaccine safety. While the incidence of cardiac events following the JYNNEOS vaccination was found to be low, healthcare providers should remain cautious, particularly when vaccinating individuals with known cardiac risk factors.
The findings emphasize the need for physician adjudication to accurately determine the true incidence of adverse events. As the monkeypox public health emergency continues, it is essential to balance the benefits of vaccination against the potential risks, ensuring that patients receive the best possible care.
The study findings were published in the peer-reviewed journal: Reactions Weekly. (Behind a paywall sadly!)
https://link.springer.com/article/10.1007/s40278-023-38622-1
A free preprint version of it can be found here:
https://www.medrxiv.org/content/10.1101/2022.11.13.22282258v1
For the latest Mpox News, keep on logging to Thailand Medical News.
Read also:
https://www.thailandmedical.news/news/concerns-rise-as-new-virulent-mpox-variants-could-have-possibly-originated-from-u-s-niaid-labs
https://www.thailandmedical.news/news/silico-study-unveils-phytochemicals-that-can-target-mpox-virus-envelope-proteins
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