Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave – Excerpts

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naturescientific reports

Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave

Scientific Reports volume 12, Article number: 6978 (2022)

Abstract

Cardiovascular adverse conditions are caused by coronavirus disease 2019 (COVID-19) infections and reported as side-effects of the COVID-19 vaccines. Enriching current vaccine safety surveillance systems with additional data sources may improve the understanding of COVID-19 vaccine safety. Using a unique dataset from Israel National Emergency Medical Services (EMS) from 2019 to 2021, the study aims to evaluate the association between the volume of cardiac arrest and acute coronary syndrome EMS calls in the 16–39-year-old population with potential factors including COVID-19 infection and vaccination rates. An increase of over 25% was detected in both call types during January–May 2021, compared with the years 2019–2020. Using Negative Binomial regression models, the weekly emergency call counts were significantly associated with the rates of 1st and 2nd vaccine doses administered to this age group but were not with COVID-19 infection rates. While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side-effects and underscore the already established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals. Surveillance of potential vaccine side-effects and COVID-19 outcomes should incorporate EMS and other health data to identify public health trends (e.g., increased in EMS calls), and promptly investigate potential underlying causes.

Introduction

Cardiovascular adverse outcomes such as blood clotting (e.g., coronary artery thrombosis), acute coronary syndrome, cardiac arrest and myocarditis have been identified as consequences of coronavirus disease 2019 (COVID-19) infection1,2,3,4,5. Similarly, data from regulatory surveillance and self-reporting systems, including the Vaccine Adverse events Reporting System (VAERS) in the United States (US)6, the Yellow Card System in the United Kingdom7 and the EudraVigilance system in Europe8, associate similar cardiovascular side-effects9,10,11,12,13 with a number of COVID-19 vaccines currently in use.

More recently, several studies established probable causal relationship between the messenger RNA (mRNA) vaccines of BNT162b2 and mRNA-127311,14,15,16 as well as adenovirus (ChAdOx1) vaccines17 with myocarditis, primarily in children, young and middle-age adults. The study by the Ministry of Health in Israel, a country with one of the highest vaccination rates in the world, assesses the risk of myocarditis after receiving the 2nd vaccine dose to be between 1 in 3000 to 1 in 6000 in men of age 16–24 and 1 in 120,000 in men under 3011,12,13. A follow up study by the US Center of Disease Control (CDC) based on the VAERS and V-Safe self-reporting systems18 further confirms these findings19. The CDC has recently posted a warning regarding a vaccine-related risk of myocarditis, but still maintained their recommendation to vaccinate young individuals and children over 127. Similar concerns are reflected in the recent Food and Drug Administration approval to the Pfizer vaccine that requires several follow studies on the short and long terms effects of myocarditis in young individuals20.

While the benefits of COVID-19 vaccination are clear, especially for populations at great risk of developing serious and potentially life-threatening illness15,21, it is important to better understand the potential risks to minimize potential harm. However, assessing the connection between myocarditis and other potential cardiovascular conditions, and the COVID-19 vaccines is challenging. First, self-reporting systems22 of adverse events are known to have self-reporting bias and both under and over-reporting problems23,24,25. Even the study from Israel that is based on more proactive data collection mentions that some of the potentially relevant cases were not fully investigated.

Second, myocarditis is a particularly insidious disease with multiple reported manifestations. There is vast literature that highlights asymptomatic cases of myocarditis, which are often underdiagnosed26,27, as well as cases in which myocarditis can possibly be misdiagnosed as acute coronary syndrome (ACS)28,29,30. Moreover, several comprehensive studies demonstrate that myocarditis is a major cause of sudden, unexpected deaths in adults less than 40 years of age, and assess that it is responsible for 12–20% of these deaths26,31,32,33. Thus, it is a plausible concern that increased rates of myocarditis among young people could lead to an increase in other severe cardiovascular adverse events, such as cardiac arrest (CA) and ACS. Anecdotal evidence suggests that this might not be only a theoretical concern16.

Third, myocardial injury and myocarditis is prevalent among patients with COVID-19 infection26,34. As COVID-19 vaccine rollouts often take place with background community COVID-19 infections, it could be challenging to identify whether increased incidence of myocarditis and related cardiovascular conditions, such as CA and ACS, is driven by COVID-19 infections or induced by COVID-19 vaccines. Moreover, such increases may even be caused by other underlying causal mechanisms indirectly related to COVID-19, for example, patients delaying seeking emergent care because of fear of the pandemic and lockdowns35.

This study aims to explore how additional data sources, such as those from emergency medical services (EMS), can complement self-reporting vaccine surveillance systems in identifying COVID-19 related public health trends. More specially, the study examines the association between CA and ACS incidents in the 16–39-year-old population and two potential causal factors: COVID-19 infection rates and COVID-19 vaccine rollout. The study leverages the Israel National EMS (IEMS) data system and analyzes all calls related to CA and ACS events over two and a half years, from January 1st, 2019, throughout June 20th, 2021.
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It is important to note the main limitation of this study, which is that it relies on aggregated data that do not include specific information regarding the affected patients, including hospital outcomes, underlying comorbidities as well as vaccination and COVID-19 positive status. Such related data are critical to determine the exact nature of the observed increase in CA and ACS calls in young people, and what the underlying causal factors are. Notably, recent studies have found vaccination induced myocardial injury has differentiating features, such as histopathology60, compared to typical myocarditis, which can further support identification of possible drivers of these cardiac events. The Israel Ministry of Health and the large HMOs have access to such data, which should be investigated in detail. Additionally, the CA examined in the study included those of both cardiac and medical etiology as data discerning these differences were not available, increasing the importance of further investigation of these patients. However, previous literature has estimated that the vast majority, approximately 84–92%, of non-traumatic cardiac arrest cases stem from cardiac origins61. For example, among other potential causes of CA, approximately 2–9% and 2% of cardiac arrests stem from pulmonary embolism62,63 and acute cerebrovascular events (e.g. subarachnoid hemorrhage)64, respectively. Therefore, it is likely that the observed changes in incidence can primarily be attributed to CAs of cardiac etiology.

The significant increases in CA calls and ACS calls among the 16–39 age population during the COVID-19 vaccination rollout highlights the value of additional data sources, such as those from EMS systems, that can supplement self-reporting surveillance systems in identifying concerning public health trends. Moreover, it underscores the need for the thorough investigation of the apparent association between COVID-19 vaccine administration and adverse cardiovascular outcomes among young adults. Israel and other countries should immediately collect the data necessary to determine whether such association indeed exists, including thorough investigation of individual CA and ACS cases in young adults, and their potential connection to the vaccine or other factors. This would be critical to better understanding the risk-benefits of the vaccine and to inform related public policy and prevent potentially avoidable patient harm. In the interim, it is vital that following vaccination, patients should be instructed to seek appropriate emergency care if they are experiencing symptoms potentially associated with myocarditis, such as chest discomfort and shortness of breath, as well as consider avoiding strenuous physical activity following the vaccination that may induce severe adverse cardiac events.

https://www.nature.com/articles/s41598-022-10928-z

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