Has there been suppression of COVID-19 vaccine safety data? Some scientists, physicians, and journalists believe there has been, as mainstream media suggest overwhelming safety and efficacy.And while the risk for myocarditis and pericarditis among mostly young males is now acknowledged, such incidences are classified as extremely rare events. But are they? In a recent study tracking population-wide data in Israel titled, “Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave,” Boston and Israel-based researchers investigate vaccine safety data associated with the Israel National Emergency Medical Services (EMS) that covers data from 2019 to 2021. The study findings add to the concerns about vaccine-induced “undetected severe cardiovascular side-effects,” underscoring the already established relationship between the mRNA-based vaccines from Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) in young male populations. The study authors strongly recommend that any COVID-19 vaccine and infection surveillance systems incorporate the Israeli and other national emergency data for a more comprehensive assessment of public health trends, not to mention deeper investigations into vaccine safety risks.
The study authors include Christopher Sun, Eli Jaffe, and Retsef Levi.
Sun is a postdoctoral fellow at MIT, while Jaffe affiliates with the Israel National Emergency Medical Services as well as the Ben Gurion University of the Negev. Retsef Levi works as a professor of operational management at Sloan School of Management.
The Study Design
The trio designed a retrospective population-based study tapping into and leveraging the national data in the IEMS system to identify calls associated with cardiovascular (CA) and acute coronary syndrome (ACS) events during the duration of the study covering January 1, 2019, to June 20th, 2021. The investigators also coupled study data with SARS-CoV-2 infection rates plus retrospective vaccination rates during the same study period.
The study duration was segmented into a ‘normal period’ associated with the time prior to the outbreak (1/2019 to 2/2020) and a 10 month ‘pandemic period’ covering two waves of the pandemic, including the first wave from 3/20 to 12/20 and a second wave from 1/21 to 6/21, during which Israel initiated the vaccination program in parallel to a third wave of the SARS-CoV-2 pandemic.
The goal of this design was to enable an analysis of how cardiovascular (CA) and acute cardiovascular syndrome (ACS) call counts changed over time with the various underlying background conditions in a quest to pinpoint elements associated with the observed temporal changes.
The study was reviewed by the Massachusetts Institute of Technology Institutional Review Board and approved by the research committee of the IEMS.
The study authors factored into the protocol a number of data sources and study population attributes, including CA and ACS call data, vaccination, and COVID-19 infection cases. Thereafter, the researchers conducted data and statistical analysis, time-series data processing for CA and ACS calls, vaccination administration, and COVID-19 infection counts, as well as an association of year-to-year call count trends with COVID-19 infection and vaccine administration data.
Then the trio conducted a sensitivity analysis to check the robustness of associations in key underlying analytical models.
High-Level Summary
The trio conducting the study out of MIT. Israel identified 30,262 cardiac arrests and 60,398 ACS calls with the following results:
Cohort
Pop
CA
ACS
Age 16-39
3.5 million
945 (3.1%)
3945 (6.5%)
Confirmed COVID-19 cases during the study period?
Of the 834,573 confirmed COVID-19 cases during the study period, 572,435 (68.6%) cases were from individuals of age 16 to 39. Among the 5,506,398 patients receiving their 1st vaccination dose and 5,152,417 patients receiving their 2nd vaccination dose, 2,382,864 (43.3%) and 2,176,172 (32.2%) patients were of age 16–39, respectively.
What data did this study leverage?
EMS CA and ACS calls in Israel over a 2.5-year period, including a period before and during the outbreak. This provides a unique perspective to investigate associations between CA and ACS call volume trends during the study period against variables such as COVID-19 infections and vaccination rates.
Why is the use of the national IEMS database beneficial?
This database offers researchers access to not only the incidence of the conditions tracked, which is markedly different from other “partial and biased access,” as well as data afforded by self-reporting adverse event systems such as the CDC’s VAERS.
Are there differences between CA and ACS EMS calls?
Yes. The study authors assume IEMS data includes nearly all relevant CA events given this call most often correlates with EMS services. Additionally, the authors post that CA diagnoses are straightforward in contrast to ACS events; the authors assume 50% of all ACS events involve hospital walk-ins and are not accounted for by MS. The authors assume a higher rate of diagnosis error with ACS events.
What is the main finding noteworthy here?
The authors show growth of greater than 25% in both the number of CA calls and ACS calls in the age 16 to 39 group during the Israeli COVID-19 vaccination rollout when compared to the same period of time in previous years (2019-2020). See table 1.
Do the authors find a “robust and statistically significant association between the weekly CA and ACS calls counts” associated with the rates of first and second vaccine doses administered to this age group?
Yes.
What about an association of CA and ACS to COVID-19 infections?
No. there is no observed statistically significant association between SARS-CoV-2 infection rates and the CA and ACS call-outs.
Do the above results match previous findings, demonstrating CA incidence isn’t always associated with higher COVID-19 infection rates at the population level?
Yes.
Do the study results align with other national results showing cardiovascular complaints associated with mass COVID-19 vaccine rollouts?
Yes. The study authors point to comparable results in Germany in addition to more EMS calls for cardiac incidents in Scotland. See Robert Koch-Institut, 2021, and Public Health Scotland—COVID-19 wider impacts on the health care system.
Do other data evidence an association of the COVID-19 jabs to CA and ACS?
Yes. For example, visuals showcased in figures 1 and 2 (see study source) “support and reinforce these findings.” The authors point out that the rise in CA and ACS calls commencing by the start of 2021 tracked closely to the administration of the second COVID-19 vaccine dose.
Do these findings match other similar findings?
Yes. Some data shows greater adverse events associated with myocarditis after the second dose of the COVID-19 vaccine. See “COVID-19 Vaccine safety updates Advisory Committee on Immunization Practices (ACIP),” June 23, 2021.
Does the data overall point to a growth in cases of CA and ACS in the age 16 to 39 population parallel to vaccination rollout?
Yes. The authors report the association with the vaccination rates could be consistent with the “known causal relationship” associated with mRNA vaccines and incidents of myocarditis in young people. The authors share multiple citations. They note myocarditis is often mistaken for ACS and that asymptomatic myocarditis “can be associated with unexplained sudden death among young adults from CA.”
Does this study data support the more anecdotal reports pointing to sudden cardiac death right after the COVID-19 vaccinations?
Yes. See Verma, A. K., Lavine, K. J. & Lin, C.-Y. Myocarditis after Covid-19 mRNA vaccination. N. Engl. J. Med. (2021) and Choi, S. et al. Myocarditis-induced sudden death after BNT162b2 mRNA COVID-19 vaccination in Korea: Case report focusing on histopathological findings. J. Korean Med. Sci. 36, 66 (2021).
In the case of myocarditis associated with the COVID-19 vaccines, are females underdiagnosed?
Possibly. The authors acknowledge research mostly associated vaccine-related myocarditis with males, and they report that “the relative increases of CA and ACS events [reported in Table 1] was larger in females.” If this doesn't represent an underdiagnosis of females it could also represent “other unique patterns…. consistent with the ongoing challenge of gender-related differences related to cardiovascular disease diagnosis and care.”
What policy and related safety implications are generated by this study?
The introduction of surveillance programs of potential COVID-19 vaccine side effects as well as COVID-19 infection outcomes to be paired with EMS as well as other health data in the quest to better identify public health trends with more impetus to rapidly investigate the possible root causes.
This is mission-critical to raise patient and doctor awareness related to suspect symptoms (chest discomfort, shortness of breath) after vaccination or COVID-19 infection to minimize risk to patients—especially with younger populations including females. Mission-critical considering the continued booster vaccination due to waning immunity of the COVID-19 vaccines against variants.
What study limitations do the authors disclose?
This study data and findings rely on aggregated data that don’t include specific data about the affected patients—such as hospital outcomes data, underlying comorbidities, and the vaccination and COVID-19 status of the patient.
TrialSite notes that this omission impacts the strength of the evidence given the above data helps researchers assess a more precise diagnosis behind the growth in both CA and ACS calls in young people paired to underlying causal factors.
The authors note that the Israeli Ministry of Health, as well as large HMOs in that nation with a heavily vaccinated population, have access to the aforementioned data and could be incorporated into future studies.
A number of other limiting factors exist for this study data.
Conclusion
The authors point out:
“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.”
Lead Research/Investigator
Christopher Sun, a postdoctoral fellow at MIT
Eli Jaffe, Israel National Emergency Medical Services as well as Ben Gurion University of the Negev and Retsef Levi
Retsef Levi, professor of operational management at Sloan School of Management