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Oral Presentation

Vaccines

Session: Evaluating the Vaccines Against the Nasty Bugs: Safety First Round II

Assessment of the Risk of Myocardial Infarction, Stroke, and Pulmonary Embolism Following Different COVID-19 Vaccines in Adults Under 75 Years of Age in France

Sunday, August 28, 2022

2:15 PM – 2:30 PM CEST

Location: C1M1

Publication Number: 274

Background: Consistently with findings from Israel and the US, we previously showed that the Pfizer/BioNTech BNT1262b2 messenger RNA (mRNA) vaccine did not appear to be associated with an increased risk of serious cardiovascular events (excluding myocarditis/pericarditis) in people aged 75 years or older in France. Though, studies conducted with other COVID-19 vaccines or in younger populations have shown heterogeneous results.

Objectives: The objective of this study was to assess the short-term risk of serious cardiovascular events (excluding myocarditis/pericarditis) associated with the different COVID-19 vaccines used in the 46.5 million adults < 75 years of age in France.

Methods: All adults < 75 years of age hospitalized for pulmonary embolism, acute myocardial infarction, or hemorrhagic or ischemic stroke in France over the period of vaccine availability until July 20, 2021, were identified from the National Health Data System (SNDS). Using an adaptation of the self-controlled case series (SCCS) method for event-dependent exposures specifically developed for the purpose of this study, we assessed the relative incidence (RI) of each cardiovascular event within 3 weeks after injection of the first and second doses (if applicable) of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), ChAdOx1 nCoV-19 (AstraZeneca), and Ad26. COV2.S (Janssen) compared to periods outside of these three weeks, adjusting for calendar temporality.

Results: The incidence of the various serious cardiovascular events was not increased in the 3 weeks following the first or second dose of the mRNA vaccines (BNT162b2 and mRNA-1273). The incidence of myocardial infarction was increased in the first and second weeks after the Ad26.COV2.S dose (IR 1.57 [95% confidence interval (CI) 1.02 to 2.44] and 1.75 [1.16 to 2.62], respectively). The incidence of myocardial infarction and pulmonary embolism was increased in the second week after the first dose of ChAdOx1 nCoV-19 (RI 1.28 [1.12 to 1.47] for myocardial infarction and 1.30 [1.04 to 1.62] for pulmonary embolism).

Conclusions: These results confirm the safety of mRNA-based vaccines with respect to the risk of serious cardiovascular events (excluding myocarditis/pericarditis) in adults younger than 75 years. Though, adenovirus vaccines appear to be associated with a slight increase in the risks of myocardial infarction and pulmonary embolism in this population.

Presenting Author(s)

SL

Stephane Le Vu

Epiphare
Saint-Denis, Seine-Saint-Denis, France

Slides

Co-Author(s)

Jeremie Botton

French National Agency for Medicines and Health Products Safety
Saint-Denis, France
MJ

Marie-Joëlle Jabagi

Epiphare, France
MB

Marion Bertrand

MSc
Epiphare, France
BB

Bérangère Baricault

Epiphare, France
JD

Jérôme Drouin

Epiphare, France
AW

Alain Weill

EPI-PHARE, Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products, and French National Health Insurance), Saint-Denis, France, France
PF

Paddy Farrington

School of Mathematics and Statistics, The Open University, United Kingdom
MZ

Mahmoud Zureik

Director
EPI-PHARE, Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products, and French National Health Insurance), Saint-Denis, France
Saint-Denis, Ile-de-France, France
RD

Rosemary Dray-Spira

EPI-PHARE, France