tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Sep 15.
doi: 10.1056/NEJMoa2110345. Online ahead of print.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
Stephen J Thomas[SUP] 1 [/SUP], Edson D Moreira Jr[SUP] 1 [/SUP], Nicholas Kitchin[SUP] 1 [/SUP], Judith Absalon[SUP] 1 [/SUP], Alejandra Gurtman[SUP] 1 [/SUP], Stephen Lockhart[SUP] 1 [/SUP], John L Perez[SUP] 1 [/SUP], Gonzalo Pérez Marc[SUP] 1 [/SUP], Fernando P Polack[SUP] 1 [/SUP], Cristiano Zerbini[SUP] 1 [/SUP], Ruth Bailey[SUP] 1 [/SUP], Kena A Swanson[SUP] 1 [/SUP], Xia Xu[SUP] 1 [/SUP], Satrajit Roychoudhury[SUP] 1 [/SUP], Kenneth Koury[SUP] 1 [/SUP], Salim Bouguermouh[SUP] 1 [/SUP], Warren V Kalina[SUP] 1 [/SUP], David Cooper[SUP] 1 [/SUP], Robert W Frenck Jr[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], Özlem Türeci[SUP] 1 [/SUP], Haylene Nell[SUP] 1 [/SUP], Axel Schaefer[SUP] 1 [/SUP], Serhat Ünal[SUP] 1 [/SUP], Qi Yang[SUP] 1 [/SUP], Paul Liberator[SUP] 1 [/SUP], Dina B Tresnan[SUP] 1 [/SUP], Susan Mather[SUP] 1 [/SUP], Philip R Dormitzer[SUP] 1 [/SUP], Uğur Şahin[SUP] 1 [/SUP], William C Gruber[SUP] 1 [/SUP], Kathrin U Jansen[SUP] 1 [/SUP], C4591001 Clinical Trial Group
Affiliations
Abstract
Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.
Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.
Results: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.
Conclusions: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).
. 2021 Sep 15.
doi: 10.1056/NEJMoa2110345. Online ahead of print.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
Stephen J Thomas[SUP] 1 [/SUP], Edson D Moreira Jr[SUP] 1 [/SUP], Nicholas Kitchin[SUP] 1 [/SUP], Judith Absalon[SUP] 1 [/SUP], Alejandra Gurtman[SUP] 1 [/SUP], Stephen Lockhart[SUP] 1 [/SUP], John L Perez[SUP] 1 [/SUP], Gonzalo Pérez Marc[SUP] 1 [/SUP], Fernando P Polack[SUP] 1 [/SUP], Cristiano Zerbini[SUP] 1 [/SUP], Ruth Bailey[SUP] 1 [/SUP], Kena A Swanson[SUP] 1 [/SUP], Xia Xu[SUP] 1 [/SUP], Satrajit Roychoudhury[SUP] 1 [/SUP], Kenneth Koury[SUP] 1 [/SUP], Salim Bouguermouh[SUP] 1 [/SUP], Warren V Kalina[SUP] 1 [/SUP], David Cooper[SUP] 1 [/SUP], Robert W Frenck Jr[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], Özlem Türeci[SUP] 1 [/SUP], Haylene Nell[SUP] 1 [/SUP], Axel Schaefer[SUP] 1 [/SUP], Serhat Ünal[SUP] 1 [/SUP], Qi Yang[SUP] 1 [/SUP], Paul Liberator[SUP] 1 [/SUP], Dina B Tresnan[SUP] 1 [/SUP], Susan Mather[SUP] 1 [/SUP], Philip R Dormitzer[SUP] 1 [/SUP], Uğur Şahin[SUP] 1 [/SUP], William C Gruber[SUP] 1 [/SUP], Kathrin U Jansen[SUP] 1 [/SUP], C4591001 Clinical Trial Group
Affiliations
- PMID: 34525277
- DOI: 10.1056/NEJMoa2110345
Abstract
Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.
Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.
Results: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.
Conclusions: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).