N Engl J Med . Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

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N Engl J Med


. 2021 Jun 30.
doi: 10.1056/NEJMoa2107659. Online ahead of print.
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine


Paul T Heath ¹ , Eva P Galiza ¹ , David N Baxter ¹ , Marta Boffito ¹ , Duncan Browne ¹ , Fiona Burns ¹ , David R Chadwick ¹ , Rebecca Clark ¹ , Catherine Cosgrove ¹ , James Galloway ¹ , Anna L Goodman ¹ , Amardeep Heer ¹ , Andrew Higham ¹ , Shalini Iyengar ¹ , Arham Jamal ¹ , Christopher Jeanes ¹ , Philip A Kalra ¹ , Christina Kyriakidou ¹ , Daniel F McAuley ¹ , Agnieszka Meyrick ¹ , Angela M Minassian ¹ , Jane Minton ¹ , Patrick Moore ¹ , Imrozia Munsoor ¹ , Helen Nicholls ¹ , Orod Osanlou ¹ , Jonathan Packham ¹ , Carol H Pretswell ¹ , Alberto San Francisco Ramos ¹ , Dinesh Saralaya ¹ , Ray P Sheridan ¹ , Richard Smith ¹ , Roy L Soiza ¹ , Pauline A Swift ¹ , Emma C Thomson ¹ , Jeremy Turner ¹ , Marianne E Viljoen ¹ , Gary Albert ¹ , Iksung Cho ¹ , Filip Dubovsky ¹ , Greg Glenn ¹ , Joy Rivers ¹ , Andreana Robertson ¹ , Kathy Smith ¹ , Seth Toback ¹ , 2019nCoV-302 Study Group



Affiliations

• PMID: 34192426
• DOI: 10.1056/NEJMoa2107659

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.).