The Phase 3 PREVENT-19 study also met the key secondary endpoint of 100% efficacy against variants not considered VoI or VoC
Novavax’ Covid-19 vaccine showed 90.4% overall efficacy in the Phase 3 trial. (Credit: pearson0612 from Pixabay.)
Novavax announced that its Covid-19 vaccine NVX-CoV2373 has showed 90.4% overall efficacy, achieving the primary endpoint in the Phase 3 PREVENT-19 trial.
Its recombinant protein-based vaccine also demonstrated 100% protection against moderate and severe Covid-19 disease in the trial.
The Phase 3 study in 29,960 participants across 119 sites in the US and Mexico evaluated the efficacy, safety and immunogenicity of the vaccine, compared with placebo.
The trial also met its key secondary endpoint of 100% efficacy against variants not considered Variants of Interest (VoI) or Variants of Concern (VoC).
NVX-CoV2373 showed 91% efficacy among high-risk populations, defined as over age 65, under age 65 with certain comorbidities or circumstances with frequent Covid-19 exposure.
Novavax president and chief executive officer Stanley Erck said: “Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”
Alongside PREVENT-19, NVX-CoV2373 is being evaluated in a Phase 3 UK trial that showed 96.4% efficacy against the original virus strain, and 86.3% against the B.1.1.7 (Alpha) variant and 89.7% overall.
Novavax intends to seek regulatory authorisations for the vaccine after completing the required process qualification and assay validation under the chemistry, manufacturing and controls (CMC) requirements.
Upon receiving regulatory approval, the company is expected to have a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter this year.
PREVENT-19 trial is being supported by the US government’s Department of Defence, the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID) through up to $1.75bn funding.
Novavax research and development president Gregory Glenn said: “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile.
“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent Covid-19 amid ongoing genetic evolution of the virus.
“Our vaccine will be a critical part of the solution to Covid-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.”