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Review
. 2024 Sep 17;42(22):126165.
doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.

A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine

Shanti Pather  1 , Nicola Charpentier  1 , Frank van den Ouweland  1 , Ruben Rizzi  1 , Andrew Finlayson  1 , Nadine Salisch  1 , Alexander Muik  1 , Claudia Lindemann  1 , Ruzwana Khanim  1 , Sultan Abduljawad  1 , Emily R Smith  2 , Marc Gurwith  3 , Robert T Chen  3 ; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG)
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Free article
Review

A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine

Shanti Pather et al. Vaccine. .
Free article

Abstract

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group evaluates the safety and other key features of new platform technology vaccines, including nucleic acid (RNA and DNA) vaccines. This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus disease 2019 (COVID-19) mRNA-based vaccine BNT162b2 (Comirnaty®, or Pfizer-BioNTech COVID-19 vaccine) including the subsequent Original/Omicron BA.1, Original/Omicron BA.4-5 and Omicron XBB.1.5 variant-adapted vaccines developed by BioNTech and Pfizer to protect against COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Initial Emergency Use Authorizations or conditional Marketing Authorizations for the original BNT162b2 vaccine were granted based upon a favorable benefit-risk assessment taking into account clinical safety, immunogenicity, and efficacy data, which was subsequently reconfirmed for younger age groups, and by real world evidence data. In addition, the favorable benefit-risk assessment was maintained for the bivalent vaccines, developed against newly arising SARS-CoV-2 variants, with accumulating clinical trial data.

Trial registration: ClinicalTrials.gov NCT04380701 NCT04368728 NCT04816643.

Keywords: BNT162b2; COVID-19 vaccine; Coronavirus; SARS-CoV-2; Vaccine benefit/risk; Vaccine safety.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The Brighton Collaboration BRAVATO authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. BioNTech authors are current employees of BioNTech, a for-profit organization, who may own stock or hold stock options. AM is an inventor on patents and/or patent applications related to RNA technology and COVID-19 vaccines.

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