Preliminary evidence on the safety profile of BNT162b2 (Comirnaty): new insights from data analysis in EudraVigilance and adverse reaction reports from an Italian health facility

Hum Vaccin Immunother. 2021 Sep 2;17(9):2969-2971. doi: 10.1080/21645515.2021.1917236. Epub 2021 May 27.

Abstract

The first vaccine against SARS-CoV-2 made available in Italy has been BNT162b2, the two-dose mRNA-based vaccine developed by Pfizer-BioNTech. The ASST Fatebenefratelli-Sacco hospital is located in one of the areas most affected by the pandemic, and to date over 2000 healthcare professionals have been injected with both vaccine doses. We have collected all spontaneous safety reports in which BNT162b2 was designated as the possible cause. We also have carried out a descriptive analysis of reports submitted in EudraVigilance in the same time-frame and compared our findings with those observed in clinical trials. We have identified several new and unexpected adverse reactions that will be helpful for reviewing the safety profile defined in the Summary of Product Characteristics for this vaccine.

Keywords: BNT162b2; COVID-19; EudraVigilance; pharmacovigilance; real-world data; vaccine.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • BNT162 Vaccine
  • COVID-19 Vaccines
  • COVID-19*
  • Data Analysis
  • Health Facilities
  • Humans
  • Italy / epidemiology
  • SARS-CoV-2*

Substances

  • COVID-19 Vaccines
  • BNT162 Vaccine

Grants and funding

This work was supported by the Regional Center of Pharmacovigilance of Lombardy (to EC); the Italian Medicines Agency; Agenzia Italiana del Farmaco (AIFA, to EC) and by the Italian Ministry of Health [Progetto Finalizzata RF-2016-02363761 to EC] which are gratefully acknowledged.