BioNTech SE, Mainz, Germany.
Brighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA.
Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
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.
布莱顿合作组织疫苗技术的获益-风险评估（BRAVATO）工作组评估了新型平台技术疫苗的安全性和其他关键特征，包括核酸（RNA 和 DNA）疫苗。本文使用 BRAVATO 模板报告了对基于信使 RNA 的 2019 年冠状病毒病（COVID-19）疫苗 BNT162b2（Comirnaty®，或辉瑞-生物技术 COVID-19 疫苗）的获益-风险评估的关键考虑因素，包括随后由生物技术公司和辉瑞公司开发的针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的 COVID-19 的原始/Omicron BA.1、原始/Omicron BA.4-5 和 Omicron XBB.1.5 变异株适应疫苗。最初的紧急使用授权或有条件的营销授权是基于对原始 BNT162b2 疫苗的有利获益-风险评估而授予的，考虑到了临床安全性、免疫原性和疗效数据，随后在年轻人群中进行了重新确认，并通过真实世界的数据得到了证实。此外，对于针对新出现的 SARS-CoV-2 变异株开发的二价疫苗，也维持了有利的获益-风险评估，同时积累了临床试验数据。
