Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update
- 5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the
- Study expanded to 15,000 participants
- Full enrollment expected by end of November
- Event-driven interim data expected as soon as early first quarter 2021
- U.S. pivotal Phase 3 clinical trial planned to begin by end of November
- Significant progress in large-scale manufacturing achieved with some delay from original timeline
- Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public
CDC Advisory Committee on Immunization Practices(ACIP) meeting on October 30
“We are pleased with the significant progress made in our Phase 3 clinical trial since it began in the
In alignment with Novavax’ commitment to transparency, the Company has posted the protocol for this trial on its website at https://www.novavax.com/resources#protocols.
U.S. Phase 3 Clinical Trial Update
Additional Phase 3 Clinical Trial Information
Novavax’ first pivotal Phase 3 clinical trial, begun in September in partnership with the
Novavax’ pivotal Phase 3 clinical trial is being conducted with support from the
Novavax’ Senior Vice President and Chief Medical Officer,
NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Source: Novavax, Inc.