Novavax says its vaccine shows 90.4% overall efficacy in Phase 3 trial

Novavax, an American biotechnology company, says its "on track" to manufacture about 100 million vaccine doses per month by the end of the third quarter this year

LINCOLN, Neb. (KLKN)- Novavax, an American biotechnology company, announced early Monday morning that its covid-19 vaccine was found to have an overall efficacy of 90.4% in a Phase 3 trial that was conducted across the U.S. and Mexico.

Novavax says there will be further analysis of the trial and the results will be submitted to peer-reviewed journals for publication.

Dr. Gregory Glenn, president of research and development for Novavax, told CNN that the trial’s results appear consistent with the efficacy and safety profile the vaccine previously showed in a Phase 3 trial conducted in the United Kingdom.

“Different continent, different population, different viruses floating around, and yet, we still see really good efficacy,” Glenn said. “This is what you want to have.”

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The study began in December 2020, enrolling 29,960 adults from 113 sites across the United States and six sites in Mexico. A portion of participants was given a placebo and a portion were given two doses of the Novavax vaccine 21 days apart.

Novavax says the vaccine was “generally well-tolerated” and the common side effects were pain at the injection site, lasting less than three days, and fatigue, headache, and muscle pain lasting less than two days.

According to the company, there were 77 cases of covid-19 that emerged among the patients during the trial. Out of those cases, 63 of them were in people in the placebo group and 14 in the vaccine group. Novavax says that all cases in the vaccine group were mild ones. 10 were con

sidered moderate and four were severe cases in the placebo group, showing a vaccine efficacy of 100% against moderate or severe disease, according to the vaccine manufacturer.

A majority of the covid-19 cases were in “high-risk” patients, those older than 65, or with certain comorbidities, or having frequent exposure to the virus. In “high-risk” populations, the company says its vaccine efficacy is 91%.

When it comes to variants of concern or of interest, Novavax reports its vaccine’s efficacy was 93.2%.

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The final analysis of Novavax’s UK Phase 3 trial results, released in March, showed that the vaccine had an overall efficacy of 89.7%, with an efficacy of 96.4% against the original virus strain and 86.3% against the B.1.1.7 variant first found in the UK.

The Novavax vaccine (NVX-CoV2373) has some differences from the three vaccines already available in the US. Novavax’s vaccine relies on what’s called recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response.

Pfizer/BioNTech’s and Moderna’s vaccines are both mRNA vaccines that were authorized in the US last year and both of them use genetic material to stimulate an immune response. The Johnson & Johnson vaccine–a single-shot dose authorized in February–uses a weakened common cold virus as a vector to carry the genetic instructions.

According to Novavax, the company intends on applying for emergency use authorization of its vaccine in the US 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.

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