Phase 3 clinical results of recombinant protein new crown vaccine candidate are positive

On June 14, 2021, Novavax announced that its recombinant protein-based nanoparticle new crown vaccine candidate NVX-CoV2373 has reached the primary endpoint in a pivotal phase 3 clinical trial, with an overall protective efficacy of 90.

NVX-CoV2373 is a recombinant protein candidate vaccine produced using Novavax’s recombinant nanoparticle technology.
In addition to containing the new coronavirus spike protein (S protein), it also contains Novavax’s proprietary saponin-based Matrix-M adjuvant, which can By stimulating antigen-presenting cells to enter the injection site, the antigen presentation in the local lymph nodes is enhanced, thereby enhancing the immune response and stimulating the production of high levels of neutralizing antibodies
.
NVX-CoV2373 can be stored and kept stable at 2°C-8°C
.

PREVENT-19, conducted in the United States and Mexico, is a randomized, double-blind, placebo-controlled, pivotal phase 3 clinical trial.
A total of 29,960 adult volunteers over 18 years old were enrolled in a 2:1 ratio of vaccination or comfort.
Agent
.

77 symptomatic COVID-19 cases were observed in the trial, of which 63 were observed in the placebo group and 14 cases were observed in the NVX-CoV2373 group.
The converted overall protective efficacy was 90.
4% (95% CI: 82.
9, 94.
6)
.
The 10 moderate and 4 severe COVID-19 cases observed in the trial were all in the placebo group, and the effectiveness of the conversion to moderate or severe COVID-19 was 100% (95% CI: 87, 100)
.

The effectiveness of NVX-CoV2373 in the "high-risk" population was 91.
0% (95% CI: 83.
6, 95.
0)
.
"High-risk" groups are defined as those over 65 years of age, those under 65 who have certain comorbidities or whose living environment is frequently exposed to COVID-19
.

Among 77 COVID-19 patients, 54 patients’ samples can provide new coronavirus genome sequence data
.
Sequencing data showed that 65% of the new coronavirus strains that infected these 54 patients belonged to VOC, 17% belonged to VOI, and 19% belonged to other mutant strains
.
Exploratory analysis showed that of the 44 patients who were confirmed to be infected by the VoC/VoI mutant through the genome sequence, 38 appeared in the control group and 6 appeared in the vaccine group
.
The validity of conversion based on these data is 93.
2% (95% CI: 83.
9, 97.
1)
.

Preliminary safety data of PREVENT-19 show that the vaccine is generally well tolerated, with a small number of serious adverse events, and a balance between the vaccine group and the placebo group
.
In assessing the reactogenicity of the first and second vaccines 7 days after vaccination, pain and tenderness at the injection site were the most common local symptoms, usually mild to moderate in severity and less than 3 days in duration
.
The most common systemic symptoms are fatigue, headache, and muscle pain, lasting less than 2 days
.
(WuXi AppTec)

Note: The original text has been deleted

Reference materials:

[1] PREVENT-19 Phase 3 TrialData Factsheet.
Retrieved June 14, 2021, from https://cdn.
filestackcontent.
com/fRM9l0gjQmKfUrWRf86M

[2] Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial.
Retrieved June 14, 2021, from https://novavax.
reportablenews.
com/pr/novavax -covid-19-vaccine-19-demonstrates-90-overall-efficacy-and-100-protection-against-moderate-and-severe-disease-in-prevent-19-phase-3-trial