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Review
. 2024 Dec 31;20(1):2315659.
doi: 10.1080/21645515.2024.2315659. Epub 2024 Feb 26.

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Frank van den Ouweland  1 , Nicola Charpentier  2 , Özlem Türeci  3 , Ruben Rizzi  4 , Federico J Mensa  5 , Claudia Lindemann  6 , Shanti Pather  7
Affiliations
Review

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Frank van den Ouweland et al. Hum Vaccin Immunother. .

Abstract

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.

Keywords: SARS-CoV-2; post-marketing surveillance; reactogenicity; real-world studies; safety; vaccine development.

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Conflict of interest statement

ÖT is a management board member and employee at BioNTech SE (Mainz, Germany) and co-founder of the company. FvO, NC, FJM, CL, SP, and RR are employees at BioNTech SE. ÖT is an inventor on patents and patent applications related to RNA technology and COVID-19 vaccines. SP, RR, CL and ÖT have securities from BioNTech SE.

Figures

Figure 1.
Figure 1.
Accelerated timelines for the development and approval of COVID-19 vaccines.,, COVID-19, coronavirus disease 2019.
See this image and copyright information in PMC

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