No association between messenger RNA-based COVID-19 vaccines and MI, pulmonary embolism
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A database analysis showed no association between messenger RNA COVID-19 vaccines and risk for acute MI, stroke or pulmonary embolism, but a slight increase in risk for PE and MI after receiving the AstraZeneca or Janssen vaccines.
“In a previous study, we found no increase in the rate of acute MI, stroke or PE after each dose of the Pfizer-BioNTech vaccine in persons aged 75 years or older in France,” Jeremie Botton, PharmD, PhD, MPH, of the National Agency for the Safety of Medicines and Health Products in France, and colleagues wrote in the study background. “This finding was consistent with several studies in other settings showing no association between cardiovascular outcomes (except myocarditis) and receipt of the messenger RNA-based vaccines. However, some studies have reported increased risk for venous thromboembolism after receipt of the Oxford-AstraZeneca vaccine and arterial thromboembolism or hemorrhagic stroke after receipt of the Pfizer-BioNTech vaccine.”
In a self-controlled case series, Botton and colleagues analyzed data for all adults in France aged 75 years and younger who were hospitalized for PE, acute MI, hemorrhagic stroke or ischemic stroke (n = 73,325 total events) from December 2020 to July 2021. The researchers linked data from the French National Health Data System and COVID-19 vaccine databases to identify hospitalizations for CV events, defined as MI, PE or stroke, and receipt of a first or second dose of the Pfizer-BioNTech, Moderna, Janssen or Oxford-AstraZeneca vaccine. Researchers estimated the relative incidence of each CV event in the 3 weeks after vaccination compared with other periods, with adjustment for temporality (7-day periods). Incidence of myocarditis and pericarditis were not included.
“An inherent statistical challenge is that it required us to investigate a large number of vaccine-event pairs, thus increasing the risk for wrongly concluding that there was an association,” the researchers wrote. “To control this, we applied the false discovery rate method.”
The findings were published in Annals of Internal Medicine.
Researchers found no association between the Pfizer-BioNTech or Moderna vaccine and severe CV events. The first dose of the Oxford-AstraZeneca vaccine was associated with acute MI and PE in the second week after vaccination, with a relative incidence of 1.29 (95% CI, 1.11-1.51) and 1.41 (CI, 1.13-1.75), respectively. Analyses were consistent across age groups; there were no associations with ischemic or hemorrhagic stroke.
The researchers also noted than an association with acute MI during the second week after a single dose of the Janssen vaccine, compared with control periods, “could not be ruled out,” with a relative incidence of 1.75 (95% CI, 1.16-2.62). This association was consistent across age groups; the Janssen vaccine was not associated with other CV events.
“Although our findings about the short-term cardiovascular safety profile of messenger RNA-based vaccines are reassuring overall, there is evidence of a moderate association with pulmonary embolism and acute MI for the Oxford-AstraZeneca vaccine and a potential risk for MI with the Janssen vaccine that would warrant confirmation in other studies,” the researchers wrote.
The researchers noted that vaccination, including with adenoviral-based vaccines, could decrease risk for a CV event by limiting the consequences of a potential SARS-CoV-2 infection.
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