Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

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Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. / Heath, Paul T.; Galiza, Eva P.; Baxter, David N. et al.
Yn: New England Journal of Medicine, Cyfrol 385, Rhif 13, 23.09.2021, t. 1172-1183.

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

HarvardHarvard

Heath, PT, Galiza, EP, Baxter, DN, Boffito, M, Browne, D, Burns, F, Clark, R, Cosgrove, C, Galloway, J, Goodman, AL, Heer, A, Higham, A, Iyengar, S, Jamal, A, Jeanes, C, Kalra, PA, Kyriakidou, C, McAuley, DF, Meyrick, A, Minassian, AM, Minton, J, Moore, P, Munsoor, I, Nicholls, H, Osanlou, O, Packham, J, Pretswell, CH, San Francisco Ramos, A, Saralaya, D, Sheridan, RP, Smith, R, Soiza, RL, Swift, PA, Thomson, EC, Turner, J, Viljoen, ME, Albert, G, Cho, I, Dubovsky, F, Glenn, G, Rivers, J, Robertson, A, Smith, K & Toback, S 2021, 'Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine', New England Journal of Medicine, cyfrol. 385, rhif 13, tt. 1172-1183. https://doi.org/10.1056/NEJMoa2107659

APA

Heath, P. T., Galiza, E. P., Baxter, D. N., Boffito, M., Browne, D., Burns, F., Clark, R., Cosgrove, C., Galloway, J., Goodman, A. L., Heer, A., Higham, A., Iyengar, S., Jamal, A., Jeanes, C., Kalra, P. A., Kyriakidou, C., McAuley, D. F., Meyrick, A., ... Toback, S. (2021). Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. New England Journal of Medicine, 385(13), 1172-1183. https://doi.org/10.1056/NEJMoa2107659

CBE

Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Clark R, Cosgrove C, Galloway J, Goodman AL, et al. 2021. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. New England Journal of Medicine. 385(13):1172-1183. https://doi.org/10.1056/NEJMoa2107659

MLA

Heath, Paul T. et al. "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine". New England Journal of Medicine. 2021, 385(13). 1172-1183. https://doi.org/10.1056/NEJMoa2107659

VancouverVancouver

Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. New England Journal of Medicine. 2021 Medi 23;385(13):1172-1183. doi: 10.1056/NEJMoa2107659

Author

Heath, Paul T. ; Galiza, Eva P. ; Baxter, David N. et al. / Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. Yn: New England Journal of Medicine. 2021 ; Cyfrol 385, Rhif 13. tt. 1172-1183.

RIS

TY - JOUR

T1 - Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

AU - Heath, Paul T.

AU - Galiza, Eva P.

AU - Baxter, David N.

AU - Boffito, Marta

AU - Browne, Duncan

AU - Burns, Fiona

AU - Clark, Rebecca

AU - Cosgrove, Catherine

AU - Galloway, James

AU - Goodman, Anna L.

AU - Heer, Amardeep

AU - Higham, Andrew

AU - Iyengar, Shalini

AU - Jamal, Arham

AU - Jeanes, Christopher

AU - Kalra, Philip A.

AU - Kyriakidou, Christina

AU - McAuley, Daniel F.

AU - Meyrick, Agnieszka

AU - Minassian, Angela M.

AU - Minton, Jane

AU - Moore, Patrick

AU - Munsoor, Imrozia

AU - Nicholls, Helen

AU - Osanlou, Orod

AU - Packham, Jonathan

AU - Pretswell, Carol H.

AU - San Francisco Ramos, Alberto

AU - Saralaya, Dinesh

AU - Sheridan, Ray P.

AU - Smith, Richard

AU - Soiza, Roy L.

AU - Swift, Pauline A.

AU - Thomson, Emma C.

AU - Turner, Jeremy

AU - Viljoen, Marianne E.

AU - Albert, Gary

AU - Cho, Iksung

AU - Dubovsky, Filip

AU - Glenn, Greg

AU - Rivers, Joy

AU - Robertson, Andreana

AU - Smith, Kathy

AU - Toback, Seth

PY - 2021/9/23

Y1 - 2021/9/23

N2 - 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.METHODSIn 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.RESULTSA 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.CONCLUSIONSA 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. opens in new tab.)

AB - 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.METHODSIn 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.RESULTSA 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.CONCLUSIONSA 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. opens in new tab.)

U2 - 10.1056/NEJMoa2107659

DO - 10.1056/NEJMoa2107659

M3 - Article

VL - 385

SP - 1172

EP - 1183

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 13

ER -