Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
Allbwn ymchwil: Cyfraniad at gyfnodolyn › Erthygl › adolygiad gan gymheiriaid
StandardStandard
Yn: New England Journal of Medicine, Cyfrol 385, Rhif 13, 23.09.2021, t. 1172-1183.
Allbwn ymchwil: Cyfraniad at gyfnodolyn › Erthygl › adolygiad gan gymheiriaid
HarvardHarvard
APA
CBE
MLA
VancouverVancouver
Author
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 -