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 -