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Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

The BNT162b2 mRNA vaccine (Pfizer-BioNTech) was the first SARS-CoV-2 vaccine authorized and the most widely used in older persons in France. Although no increases in cardiovascular events were reported in phase 3 trials,1 questions emerged once the vaccine was used on a large scale because older people were underrepresented in the trials. We evaluated the short-term risk of severe cardiovascular events among French people aged 75 years or older after the administration of the BNT162b2 mRNA vaccine.

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Article Information

Corresponding Author: Marie Joelle Jabagi, PharmD, PhD, EPI-PHARE, 143-147 Boulevard Anatole France, F-93285 Saint-Denis CEDEX, France (marie-joelle.jabagi@ansm.sante.fr).

Accepted for Publication: November 15, 2021.

Published Online: November 22, 2021. doi:10.1001/jama.2021.21699

Author Contributions: Dr Jabagi and Ms Bertrand had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Jabagi, Botton, Bertrand, Weill, Zureik, Dray-Spira.

Drafting of the manuscript: Jabagi, Bertrand, Zureik.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Jabagi, Botton, Bertrand, Farrington.

Supervision: Botton, Weill, Zureik, Dray-Spira.

Conflict of Interest Disclosures: None reported.

Additional Contributions: Stephane Le Vu, PharmD, PhD, and Kim Bouillon, MD, PhD, EPI-PHARE, reviewed the manuscript without compensation. Bérangère Baricault, MSc, and Jerome Drouin, MSc, EPI-PHARE, provided unpaid technical support related to data management.

References
1.
Polack  FP , Thomas  SJ , Kitchin  N ,  et al; C4591001 Clinical Trial Group.  Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine.   N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577PubMedGoogle ScholarCrossref
2.
Farrington  CP , Whitaker  HJ , Hocine  MN .  Case series analysis for censored, perturbed, or curtailed post-event exposures.   Biostatistics. 2009;10(1):3-16. doi:10.1093/biostatistics/kxn013PubMedGoogle ScholarCrossref
3.
Barda  N , Dagan  N , Ben-Shlomo  Y ,  et al.  Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting.   N Engl J Med. 2021;385(12):1078-1090. doi:10.1056/NEJMoa2110475PubMedGoogle ScholarCrossref
4.
Klein  NP , Lewis  N , Goddard  K ,  et al.  Surveillance for adverse events after COVID-19 mRNA vaccination.   JAMA. 2021;326(14):1390-1399. doi:10.1001/jama.2021.15072PubMedGoogle ScholarCrossref
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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