tetano
Editor, Senior Moderator
Vaccine
. 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[SUP] 1 [/SUP], Nicola Charpentier[SUP] 1 [/SUP], Frank van den Ouweland[SUP] 1 [/SUP], Ruben Rizzi[SUP] 1 [/SUP], Andrew Finlayson[SUP] 1 [/SUP], Nadine Salisch[SUP] 1 [/SUP], Alexander Muik[SUP] 1 [/SUP], Claudia Lindemann[SUP] 1 [/SUP], Ruzwana Khanim[SUP] 1 [/SUP], Sultan Abduljawad[SUP] 1 [/SUP], Emily R Smith[SUP] 2 [/SUP], Marc Gurwith[SUP] 3 [/SUP], Robert T Chen[SUP] 3 [/SUP]; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG)
Affiliations
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.
Keywords: BNT162b2; COVID-19 vaccine; Coronavirus; SARS-CoV-2; Vaccine benefit/risk; Vaccine safety.
. 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[SUP] 1 [/SUP], Nicola Charpentier[SUP] 1 [/SUP], Frank van den Ouweland[SUP] 1 [/SUP], Ruben Rizzi[SUP] 1 [/SUP], Andrew Finlayson[SUP] 1 [/SUP], Nadine Salisch[SUP] 1 [/SUP], Alexander Muik[SUP] 1 [/SUP], Claudia Lindemann[SUP] 1 [/SUP], Ruzwana Khanim[SUP] 1 [/SUP], Sultan Abduljawad[SUP] 1 [/SUP], Emily R Smith[SUP] 2 [/SUP], Marc Gurwith[SUP] 3 [/SUP], Robert T Chen[SUP] 3 [/SUP]; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG)
Affiliations
- PMID: 39197299
- DOI: 10.1016/j.vaccine.2024.126165
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.
Keywords: BNT162b2; COVID-19 vaccine; Coronavirus; SARS-CoV-2; Vaccine benefit/risk; Vaccine safety.