Search This Blog

Thursday, July 1, 2021

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

 

  • Paul T. Heath, F.R.C.P.C.H., 
  • Eva P. Galiza, M.B., B.S., 
  • David N. Baxter, M.D., Ph.D., 
  • Marta Boffito, M.D., Ph.D., 
  • Duncan Browne, M.D., 
  • Fiona Burns, Ph.D., 
  • David R. Chadwick, Ph.D., 
  • Rebecca Clark, M.B., Ch.B., 
  • Catherine Cosgrove, Ph.D., 
  • James Galloway, Ph.D., 
  • Anna L. Goodman, D.Phil., 
  • Amardeep Heer, M.B., Ch.B., 
  •  for the 2019nCoV-302 Study Group*

  • DOI: 10.1056/NEJMoa2107659

  • PDF: 
  • https://www.nejm.org/doi/pdf/10.1056/NEJMoa2107659?articleTools=true

  • Abstract

    BACKGROUND

    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.)


  • https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

  • No comments:

    Post a Comment

    Note: Only a member of this blog may post a comment.