Novavax will seek authorization of vaccine against covid-19 0:44
(CNN) -
US biotech company Novavax announced Monday that its coronavirus vaccine candidate has an overall efficacy of 90.4% in a phase 3 trial conducted in the United States and Mexico.
Additional analysis of the trial is underway, according to the company, and will be submitted to peer-reviewed journals for publication.
The trial results appear consistent with the efficacy and safety profile that the vaccine previously displayed in a phase 3 trial conducted in the United Kingdom, Dr. Gregory Glenn, Novavax president of research and development, told CNN.
"Different continent, different population, different viruses floating around and yet we still see really good efficacy," Glenn said.
"This is what you want."
The study began in December with the enrollment of 29,960 adults in 113 locations in the United States and six in Mexico.
Some of the participants were given a placebo and others were given two doses of the Novavax vaccine 21 days apart.
advertising
This is how the race for the covid-19 vaccine goes 1:52
The company said the vaccine was "generally well tolerated" and common side effects included injection site pain, lasting less than three days, and fatigue, headache and muscle pain, lasting less. two days.
There were 77 cases of Covid-19 that emerged among the participants during the study, according to Novavax.
Sixty-three of the cases occurred in people in the placebo group and 14 in the vaccine group.
The company noted that all cases in the vaccine group were mild.
There were 10 moderate and four severe cases in the placebo group, demonstrating 100% vaccine efficacy against moderate or severe disease, according to Novavax.
Most of the cases occurred in "high risk" people, such as those over 65 years of age, with certain comorbidities or with frequent exposure to COVID-19.
The company announced that the efficacy of the vaccine was 91% in "high risk" populations.
Most effective vaccines against covid-19 (so far) 0:46
The Novavax researchers also looked closely at the sequencing data for 54 of the 77 COVID-19 cases in the study.
Based on the sequencing of these cases, the company announced that the "vaccine efficacy was 93.2%" against variants of interest or concern.
A final analysis of the results of Novavax's phase 3 trial in the UK, announced in March, showed that the vaccine had an overall efficacy of 89.7%, and its efficacy was 96.4% against the coronavirus strain. original and 86.3% against variant B.1,1.7 first identified in the UK.
Novavax's coronavirus vaccine, called NVX-CoV2373, differs from the three vaccines already in use in the United States.
The vaccine is based on what is called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response.
The two mRNA vaccines that were licensed in the United States last year, from Pfizer / BioNTech and Moderna, use genetic material to stimulate an immune response.
Johnson & Johnson's single-shot vaccine, which was licensed in February, uses a weakened common cold virus as a vector to transmit genetic instructions.
Novavax said Monday that it plans to apply in the United States for emergency use authorization for its vaccine in the third quarter of this year and is "on track" to manufacture about 100 million doses per month by the end of the third quarter.
novavaxvaccine against covid-19
