It’s hard to believe the majority of 2020 was spent in a pandemic. The world came to a screeching halt and the entire scientific community worked tirelessly to find ways to keep each other safe. However, we all have experienced highs and lows due to COVID-19. But we were fortunate to have Operation Warp Speed to help produce and deliver millions of doses of safe and effective vaccines against the COID-19 virus.1
It is well known that traditional risk factors such as hyperlipidemia, hypertension, diabetes, and obesity are modifiable risk factors for coronary artery disease. Through the evolution of research, inflammation and infection were also discovered to play a role in developing an acute myocardial infarction (MI).2,3 After the epidemics of influenza in Europe and the US in the early 1900s, it was speculated that there is a relationship between influenza and MI. This was on the basis that excess mortality was due to other causes than influenza, such as heart disease.4 Mechanistically, influenza causes platelet aggregation leading to MI. This finding (along with others) led the American Heart Association and American College of Cardiology in 2006 to recommend influenza immunization as a part of comprehensive secondary prevention in persons with coronary and other atherosclerotic vascular diseases (class I, level B).5
Based on our past experiences of viral infections and the current pandemic-state, what emerged was that on November 20, 2020, Pfizer and BioNTech (the sponsor) submitted an Emergency Use Authorization (EUA) request to the FDA for an investigational COVID-19 vaccine. The purposed use under a EUA is for active immunization for the prevention of COIVD-19 caused by SARS-CoV-2 in individuals 16 years of age and older; with a 2 doses regimen, administered 21 days apart.1
There are many safety and side effects to discuss regarding the vaccine (any vaccine for that matter) but I’ll be focusing on the cardiovascular risk profile. The most frequent comorbidities were obesity (35.1%), diabetes (8.4%), and pulmonary disease (7.8%).1 Other baseline characteristics included: myocardial infarction (1%), peripheral vascular disease (0.6%), congestive heart failure (0.4%), and hypertension (24.5%).1
Of the serious adverse events, a total of 6 deaths (2 vaccines, 4 placeboes) from the total 43,448 participants occurred. Both vaccine recipients were >55, one experienced a cardiac arrest 62 days after the second vaccination dose and the other died from arteriosclerosis 3 days after the first dose. From the placebo group, only 1 patient died from an MI. Interestingly, 1 patient had ventricular arrhythmia but was known to have cardiac disease. Overall, there was no imbalance in severe adverse cardiovascular events. In general, serious adverse events were uncommon and represented medical events that occurred at a similar frequency in the general population.1
Some of the gaps from the safety reporting of the COVID-19 vaccine includes; duration of protection – as the participants are not more than 2 months out from initially receiving the vaccine, the et of immunocompromised individuals is too small to evaluate efficacy (i.e. heart transplant recipients ), children <16, and pregnant/lactating individuals.
Where does this leave us as leaders in the health community? We can recognize that the benefits do outweigh the risks and continued efforts will be made to monitor the health of Americans. At this point, I believe we can clearly communicate potential cardiovascular outcomes with our patients to help them make an informed decision.
- Vaccines and related biological products advisory committee meeting. FDA briefing documents. Pfizer-BioNTech COVID-19 vaccine.
- Epstein SE, Zhou YF, Zhu J. Infection and atherosclerosis: emerging mechanistic paradigms. Circulation. 1999;100:20-28
- Syrjanen J. Infection as a risk factor for cerebral infacrtion. Eur Heart J. 1993;14:17-19.
- Collins SD. Excess mortality from causes other than influenza and pneumonia during influenza epidemics. Public Health Rep. 1932;47:2159-2168.
- Smith SC Jr, Allen J, Blair Sn, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update. Circulation 2006;113:2363-72
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