Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

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Dangosydd eitem ddigidol (DOI)

  • Paul T. Heath
  • Eva P. Galiza
  • David N. Baxter
  • Marta Boffito
  • Duncan Browne
  • Fiona Burns
  • Rebecca Clark
  • Catherine Cosgrove
  • James Galloway
  • Anna L. Goodman
  • Amardeep Heer
  • Andrew Higham
  • Shalini Iyengar
  • Arham Jamal
  • Christopher Jeanes
  • Philip A. Kalra
  • Christina Kyriakidou
  • Daniel F. McAuley
  • Agnieszka Meyrick
  • Angela M. Minassian
  • Jane Minton
  • Patrick Moore
  • Imrozia Munsoor
  • Helen Nicholls
  • Orod Osanlou
  • Jonathan Packham
  • Carol H. Pretswell
  • Alberto San Francisco Ramos
  • Dinesh Saralaya
  • Ray P. Sheridan
  • Richard Smith
  • Roy L. Soiza
  • Pauline A. Swift
  • Emma C. Thomson
  • Jeremy Turner
  • Marianne E. Viljoen
  • Gary Albert
  • Iksung Cho
  • Filip Dubovsky
  • Greg Glenn
  • Joy Rivers
  • Andreana Robertson
  • Kathy Smith
  • Seth Toback
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. opens in new tab.)
Iaith wreiddiolSaesneg
Tudalennau (o-i)1172-1183
CyfnodolynNew England Journal of Medicine
Cyfrol385
Rhif y cyfnodolyn13
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsCyhoeddwyd - 23 Medi 2021
Gweld graff cysylltiadau