« G7 Cornwall Summit — Summit Meeting Agenda | Main | Bloomberg Philanthropies 2021 Mayors Challenge Names Top 50 Global Urban Innovations Emerging From Pandemic. »
June 14, 2021
Novavax says its COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial.
93% efficacy against predominantly circulating Variants of Concern and Variants of Interest.
91% efficacy in high-risk populations
100% efficacy against variants “not considered Variants of Concern/Interest.”
Photo: Novavax laboratory scientist. Image Credit: Patrick Seibert/ Novavax.
GAITHERSBURG, Md., June 14, 2021, — Novavax, Inc. today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity, emphasizing recruiting a representative population of communities and demographic groups most impacted by the disease.
“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,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax. “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.”
“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “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.”
In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6), achieving its primary endpoint, the company said.
According to Novavax, preliminary safety data from PREVENT-19 showed the vaccine to be generally well-tolerated. Severe and adverse events were low in number and balanced between vaccine and placebo groups. In assessing reactogenicity seven days after Dose 1 and Dose 2, injection site pain and tenderness, generally mild to moderate in severity, were the most common local symptoms, lasting less than three days. Fatigue, headache, and muscle pain were the most common systemic symptoms, lasting less than two days.
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded study. It evaluates the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in 29,960 participants 18 years of age and older in 119 locations in the United States and Mexico, compared with placebo.
Novavax said it is conducting PREVENT-19 with support from the U.S. government. The government agencies involved include the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. Its packaging comprises a ready-to-use liquid formulation in 10-dose vials.
Novavax expects to share further details of the PREVENT-19 trial results as additional data become available. Other analyses of the trial are ongoing. The company would submit them to peer-review journals for publication.
The company intends to file for regulatory authorizations in the third quarter to complete the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach 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 of 2021.
Source: Novavax, Inc.
|GlobalGiants.Com|
Edited & Posted by the Editor | 11:09 AM | Link to this Post
