Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
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Heath Paul T, Galiza Eva P, Baxter David N, Boffito Marta, Browne Duncan, Burns Fiona, Chadwick David R, Clark Rebecca, Cosgrove Catherine, Galloway James, Goodman Anna L, Heer Amardeep, Higham Andrew, Iyengar Shalini, Jamal Arham, Jeanes Christopher, Kalra Philip A, Kyriakidou Christina, McAuley Daniel F, Meyrick Agnieszka, Minassian Angela M, Minton Jane, Moore Patrick, Munsoor Imrozia, Nicholls Helen, Osanlou Orod, Packham Jonathan, Pretswell Carol H, San Francisco Ramos Alberto, Saralaya Dinesh, Sheridan Ray P, Smith Richard, Soiza Roy L, Swift Pauline A, Thomson Emma C, Turner Jeremy, Viljoen Marianne E, Albert Gary, Cho Iksung, Dubovsky Filip, Glenn Greg, Rivers Joy, Robertson Andreana, Smith Kathy, Toback Seth, 2019nCoV-302 Study Group
Аннотация
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.).