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

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
• safety
• reactogenicity
• vaccine development
• post-marketing surveillance
• real-world studies

Acknowledgments

Medical writing support, including assisting authors with the development of the outline and initial draft and incorporation of comments was provided by Rachel Wright, PhD, and Helene Wellington, MS, and editorial support was provided by Ian Norton, PhD, all of Scion, London, UK, supported by BioNTech SE according to Good Publication Practice guidelines (Link).

Disclosure 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.

Author contributions

All authors contributed to the manuscript conception, writing, and review process, and approved the final version for submission.

Additional information

Funding

The work was supported by the BioNTech .