tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Jun 30.
doi: 10.1056/NEJMoa2107659. Online ahead of print.
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
Paul T Heath[SUP] 1 [/SUP], Eva P Galiza[SUP] 1 [/SUP], David N Baxter[SUP] 1 [/SUP], Marta Boffito[SUP] 1 [/SUP], Duncan Browne[SUP] 1 [/SUP], Fiona Burns[SUP] 1 [/SUP], David R Chadwick[SUP] 1 [/SUP], Rebecca Clark[SUP] 1 [/SUP], Catherine Cosgrove[SUP] 1 [/SUP], James Galloway[SUP] 1 [/SUP], Anna L Goodman[SUP] 1 [/SUP], Amardeep Heer[SUP] 1 [/SUP], Andrew Higham[SUP] 1 [/SUP], Shalini Iyengar[SUP] 1 [/SUP], Arham Jamal[SUP] 1 [/SUP], Christopher Jeanes[SUP] 1 [/SUP], Philip A Kalra[SUP] 1 [/SUP], Christina Kyriakidou[SUP] 1 [/SUP], Daniel F McAuley[SUP] 1 [/SUP], Agnieszka Meyrick[SUP] 1 [/SUP], Angela M Minassian[SUP] 1 [/SUP], Jane Minton[SUP] 1 [/SUP], Patrick Moore[SUP] 1 [/SUP], Imrozia Munsoor[SUP] 1 [/SUP], Helen Nicholls[SUP] 1 [/SUP], Orod Osanlou[SUP] 1 [/SUP], Jonathan Packham[SUP] 1 [/SUP], Carol H Pretswell[SUP] 1 [/SUP], Alberto San Francisco Ramos[SUP] 1 [/SUP], Dinesh Saralaya[SUP] 1 [/SUP], Ray P Sheridan[SUP] 1 [/SUP], Richard Smith[SUP] 1 [/SUP], Roy L Soiza[SUP] 1 [/SUP], Pauline A Swift[SUP] 1 [/SUP], Emma C Thomson[SUP] 1 [/SUP], Jeremy Turner[SUP] 1 [/SUP], Marianne E Viljoen[SUP] 1 [/SUP], Gary Albert[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Filip Dubovsky[SUP] 1 [/SUP], Greg Glenn[SUP] 1 [/SUP], Joy Rivers[SUP] 1 [/SUP], Andreana Robertson[SUP] 1 [/SUP], Kathy Smith[SUP] 1 [/SUP], Seth Toback[SUP] 1 [/SUP], 2019nCoV-302 Study Group
Affiliations
Abstract
Background: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population.
Methods: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline.
Results: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups.
Conclusions: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).
. 2021 Jun 30.
doi: 10.1056/NEJMoa2107659. Online ahead of print.
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
Paul T Heath[SUP] 1 [/SUP], Eva P Galiza[SUP] 1 [/SUP], David N Baxter[SUP] 1 [/SUP], Marta Boffito[SUP] 1 [/SUP], Duncan Browne[SUP] 1 [/SUP], Fiona Burns[SUP] 1 [/SUP], David R Chadwick[SUP] 1 [/SUP], Rebecca Clark[SUP] 1 [/SUP], Catherine Cosgrove[SUP] 1 [/SUP], James Galloway[SUP] 1 [/SUP], Anna L Goodman[SUP] 1 [/SUP], Amardeep Heer[SUP] 1 [/SUP], Andrew Higham[SUP] 1 [/SUP], Shalini Iyengar[SUP] 1 [/SUP], Arham Jamal[SUP] 1 [/SUP], Christopher Jeanes[SUP] 1 [/SUP], Philip A Kalra[SUP] 1 [/SUP], Christina Kyriakidou[SUP] 1 [/SUP], Daniel F McAuley[SUP] 1 [/SUP], Agnieszka Meyrick[SUP] 1 [/SUP], Angela M Minassian[SUP] 1 [/SUP], Jane Minton[SUP] 1 [/SUP], Patrick Moore[SUP] 1 [/SUP], Imrozia Munsoor[SUP] 1 [/SUP], Helen Nicholls[SUP] 1 [/SUP], Orod Osanlou[SUP] 1 [/SUP], Jonathan Packham[SUP] 1 [/SUP], Carol H Pretswell[SUP] 1 [/SUP], Alberto San Francisco Ramos[SUP] 1 [/SUP], Dinesh Saralaya[SUP] 1 [/SUP], Ray P Sheridan[SUP] 1 [/SUP], Richard Smith[SUP] 1 [/SUP], Roy L Soiza[SUP] 1 [/SUP], Pauline A Swift[SUP] 1 [/SUP], Emma C Thomson[SUP] 1 [/SUP], Jeremy Turner[SUP] 1 [/SUP], Marianne E Viljoen[SUP] 1 [/SUP], Gary Albert[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Filip Dubovsky[SUP] 1 [/SUP], Greg Glenn[SUP] 1 [/SUP], Joy Rivers[SUP] 1 [/SUP], Andreana Robertson[SUP] 1 [/SUP], Kathy Smith[SUP] 1 [/SUP], Seth Toback[SUP] 1 [/SUP], 2019nCoV-302 Study Group
Affiliations
- PMID: 34192426
- DOI: 10.1056/NEJMoa2107659
Abstract
Background: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population.
Methods: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline.
Results: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups.
Conclusions: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).