No Uptick in CVD Events After COVID-19 Vaccination in Older Adults

There is no short-term risk of severe cardiovascular events in older adults who are vaccinated against COVID-19 with the Pfizer/BioNTech mRNA vaccine, according to the results of new observational study from France.

Among more than 6 million adults aged 75 or older, investigators observed no increased risk of hospitalization for myocardial infarction, stroke, or pulmonary embolism (PE) in the 14 days following either the first or second dose of the BNT162b2 vaccine. The data, say investigators, provide solid evidence that this vaccine is not associated with a heightened risk of these adverse CVD events in older subjects.

“The findings of our study regarding the BNT162b2 vaccine's short-term cardiovascular safety profile in older people are reassuring,” lead investigator Marie Joelle Jabagi, PharmD, PhD (EPI-PHARE/French National Agency for Medicines and Health Products Safety, Saint-Denis, France), told TCTMD via email. The results, she added, line up with data from the United States and Israel showing that the vaccine is not associated with an increased risk of MI, PE, or cerebrovascular events within the first 21 and 42 days after vaccination, respectively.

Easing MI, Stroke, and PE Concerns

The BNT162b2 vaccine was the first SARS-CoV-2 vaccine approved in France and remains the most widely used. During the phase III trials, there was no sign of increased cardiovascular risk with the vaccine, but those 75 years and older were not well represented in the clinical studies. Some concerns about cardiovascular, thromboembolic, and hemorrhagic risks associated with the vaccines emerged after the studies were completed, said Jabagi.

The European Medicines Agency, for example, have listed venous thromboembolism as a possible, but very rare, side effect with the adenovirus-vector Oxford/AstraZeneca and Janssen vaccines, which have also been tied to rare cases of vaccine-induced immune thrombocytopenia (VITT). The mRNA vaccines, on the other hand, have been linked to very rare clotting disorders, though the bigger concern has been the signal of increased myocarditis and pericarditis. In all instances, cardiovascular side effects have been documented primarily in younger adults.

As part of the population-based study, which was published November 23, 2021, in JAMA, researchers obtained details from the French National Health Data System that is linked to the national COVID-19 vaccination database. Eligible participants for the analysis were aged at least 75 years old, either vaccinated or unvaccinated, and had been admitted to the hospital between December 2020 and April 2021 for acute MI, stroke, or PE. Data were analyzed using an adapted self-controlled case series method for cardiovascular event-dependent exposures, said Jabagi, which allowed them to compensate for the lack of randomization by taking into account confounding factors and dependence of vaccinations and observed periods on clinical events. 

By the end of April 2021, 3.9 million people 75 years and older received at least one dose of BNT162b2 and 3.2 million had received two doses. In the 14 days after vaccination with either dose, there was no significant increased risk of MI, stroke, or PE. When subdivided into two exposure intervals—the first 7 days and days 8 to 14—again, no significant increased risk was observed with vaccination.

“This should close the book on the concerns about these three cardiovascular events studied here—myocardial infarction, stroke, pulmonary embolism—in older people vaccinated with the BNT162b2 vaccine,” said Jabagi. Further studies, however, are still needed to assess these risks in younger subjects, as well as with other vaccines, she added. “Also, other investigations are needed to evaluate other cardiovascular risks such as myocarditis and pericarditis after vaccination with the BNT162b2.”