دورية أكاديمية
A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine.
| العنوان: | A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. |
|---|---|
| المؤلفون: | Pather S; BioNTech SE, Mainz, Germany., Charpentier N; BioNTech SE, Mainz, Germany., van den Ouweland F; BioNTech SE, Mainz, Germany., Rizzi R; BioNTech SE, Mainz, Germany., Finlayson A; BioNTech SE, Mainz, Germany., Salisch N; BioNTech SE, Mainz, Germany., Muik A; BioNTech SE, Mainz, Germany., Lindemann C; BioNTech SE, Mainz, Germany., Khanim R; BioNTech SE, Mainz, Germany., Abduljawad S; BioNTech SE, Mainz, Germany., Smith ER; Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA. Electronic address: bc-coordinator@taskforce.org., Gurwith M; Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA., Chen RT; Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA. |
| مؤلفون مشاركون: | Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG) |
| المصدر: | Vaccine [Vaccine] 2024 Sep 17; Vol. 42 (22), pp. 126165. Date of Electronic Publication: 2024 Aug 27. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Amsterdam, The Netherlands : Elsevier Science Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983- |
| مواضيع طبية MeSH: | COVID-19 Vaccines*/adverse effects , COVID-19 Vaccines*/immunology , COVID-19 Vaccines*/administration & dosage , COVID-19*/prevention & control , BNT162 Vaccine*/immunology , SARS-CoV-2*/immunology , SARS-CoV-2*/genetics , mRNA Vaccines*, Humans ; Risk Assessment ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/immunology ; Immunogenicity, Vaccine |
| مستخلص: | 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. Competing Interests: 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. (Published by Elsevier Ltd.) |
| فهرسة مساهمة: | Keywords: BNT162b2; COVID-19 vaccine; Coronavirus; SARS-CoV-2; Vaccine benefit/risk; Vaccine safety |
| المشرفين على المادة: | 0 (COVID-19 Vaccines) 0 (BNT162 Vaccine) 0 (mRNA Vaccines) 0 (Vaccines, Synthetic) |
| SCR Organism: | SARS-CoV-2 variants |
| تواريخ الأحداث: | Date Created: 20240828 Date Completed: 20240902 Latest Revision: 20240904 |
| رمز التحديث: | 20240904 |
| DOI: | 10.1016/j.vaccine.2024.126165 |
| PMID: | 39197299 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1873-2518 |
|---|---|
| DOI: | 10.1016/j.vaccine.2024.126165 |