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Additionally, no increase in incidences of stroke or pulmonary embolism were seen 14 days after the 2 vaccine doses.
A recent investigation from France found that patient 75 years or older who received the BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech) did not experience increased risk of cardiovascular events 14 days after either vaccination.
No increase in the incidence of acute myocardial infarction, stroke, or pulmonary embolism were detected during the study.
The BNT162b2 mRNA vaccine was the first vaccine authorized for use against the COVID-19 virus in France.
Since then, questions were raised regarding the risk of cardiovascular events in older people.
Despite no increase in such events being recorded in phase 3 trials of the vaccine, investigators led by Marie Joelle Jabagi, PhD, EPI-PHARE, French National Agency for Medicines and Health Products Safety, French National Health Insurance, Saint-Denis, France, evaluated the short-term risk of severe cardiovascuklar events among French people 75 years and older after administration of the vaccine.
Jabagi and colleagues utilized data from the French National Health Data System, which was linked to the national COVID-19 vaccination database.
Eligible participants for the population-based study included all persons unvaccinated or vaccinated with the BNT162b2 vaccine who were 75 years and older and admitted to the hospital between December 15, 2020, and April 30, 2021.
Hospital admissions would have to pertain to acute myocardial infarction, hemorrhagic stroke, ischemic stroke, or pulmonary embolism.
Investigators conducted in-person comparisons using a self-controlled case-series method that was adapted to cardiovascular event-dependent exposures and high event-related mortality.
Exposure risk intervals were days 1 through 14 following the 2 doses of the BNT162b2 vaccine, and unbiased estimating equations were used to establish the relative incidence (RI) adjusted for temporality to consider changes in background rates of events and vaccination.
All analyses were performed using Scientific Committee on Consumer Safety (SCCS) package in R, version 3.6.1, and a 95% CI around the RI that did not include 1 defined statistical significance.
At the end of the study period, Jabagi and investigators observed that nearly 3.9 million people 75 years or older had received at least 1 dose of the BNT162b2 vaccine, with a total of 3.2 million having received 2 doses.
During the observation period, 11,113 persons aged 75 years or older were hospitalized for an acute myocardial infarction (58.6% received at least 1 vaccination), 17,014 (54%) for an ischemic stroke, 4804 (42.7%) for a hemorrhagic stroke, and 7221 (55.3%) for pulmonary embolism.
In the 14 days that followed either dose, the investigators observed no significant increase in risk of cardiovascular events.
Regarding myocardial infarction, the RI for the first dose was 0.97 (95% CI, 0.88-1.06) and for the second dose, 1.04 (95% CI, 0.93-1.16).
For ischemic stroke for the first dose, the RI was 0.90 (95% CI, 0.84-0.98) and for the second dose, 0.92 (95% CI, 0.84-1.02).
Regarding Ri for hemorrhagic stroke for the first dose, 0.90 (95% CI, 0.78-1.04) and for the second dose, 0.97 (95% CI, 0.81-1.15); and for pulmonary embolism for the first dose, the RI was 0.85 (95% CI, 0.75-0.96) and 1.10 (95% CI, 0.95-1.26) for the second dose.
Previous studies from Israel and the US had come to similar conclusions, with investigators from the present study believing their work provided further evidence regarding the risk of serious cardiovascular events in older patients.
However, they suggested additional studies be conducted in different patient populations.
Further investigations are needed to measure these risks in younger populations and for other types of vaccines against SARS-CoV-2.
The study, “Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older,” was published online in JAMA Network.