U.S. clinical trial results show Novavax vaccine is safe and prevents COVID-19
Results from a Phase 3 clinical trial registering 29,960 adult volunteers from the USA and Mexico demonstrate that the investigational vaccine called NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. The offender showed 100% protection against severe and moderate illness. In individuals at high risk of developing complications in COVID-19 (individuals 65 decades or older and individuals under age 65 with particular comorbidities or with probably regular vulnerability to COVID-19), the vaccine demonstrated 91.0% efficacy in preventing symptomatic COVID-19 disease.
Safety statistics indicate that the investigational vaccine was normally well-tolerated. Mild-to-moderate injection site tenderness and pain were the most popular regional symptoms of participants, and exhaustion, headache and muscular pain lasting less than two times would be the most common systemic symptoms.
Novavax, Inc., of Gaithersburg, Maryland, developed the investigational vaccine and led the clinical trial called PREVENT-19(connection is outside ). The Biomedical Advanced Research and Development Authority (BARDA), a Part of the HHS Office of the Assistant Secretary for Preparedness and Response, along with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, provided funding support to the trial as part of the National COVID-19 response.
The PREVENT-19 trial started in late December 2020 and registered adult volunteers in 119 research websites, including those from the NIAID-supported COVID-19 Prevention Network (CoVPN)(connection is outside ). Participants were randomly assigned to get two shots, 21 days apart, of either the investigational vaccine or a saline placebo. Randomization happened in a 2:1 ratio with just two volunteers getting NVX-CoV2373 for every person who received placebo. Since the trial was blinded, neither researchers nor participants knew that they obtained that the candidate vaccine.
PREVENT-19 was created to assess whether NVX-CoV2373 can stop symptomatic COVID-19 disease seven or more times following the second shot relative to placebo. The outcomes shared now derive from 77 cases of symptomatic COVID-19 that researchers detected one trial participants from January 25 through April 30, 2021. Researchers recorded 63 cases one of the roughly 10,000 participants that received placebo and 14 cases one of the roughly 20,000 participants that received the investigational vaccine. Of the 63 COVID-19 instances in the placebo group, researchers classified 10 as four and moderate as acute. There were no instances of mild or severe disease from the investigational vaccine collection.
NVX-CoV2373 is a subunit vaccine created by a stabilized form of the coronavirus spike protein employing the organization's recombinant protein nanoparticle technology. The purified protein antigens from the vaccine can't replicate or cause COVID-19. The vaccine also includes a proprietary adjuvant, MatrixM™. Adjuvants are additives which improve desired immune system reactions to vaccine. NVX-CoV2373 is administered by injection in liquid form and may be stored, managed and dispersed in above-freezing temperatures (35° to 46°F.) A single embryo dose includes 5 micrograms (mcg) of protein and 50 mcg of adjuvant. The vaccine is administered as two intramuscular injections 21 days apart. The technology employed for this particular vaccine was designed under a longstanding contract with the Department of Defense.
Results from a Phase 3 clinical trial enrolling 15,000 adults from the United Kingdom revealed a two-dose routine of NVX-CoV2373 has been exceptionally effective(link is outside ) in preventing symptomatic COVID-19 general and also demonstrated high efficacy against the Alpha variant strain of SARS-CoV-2.