To date, 5,500 volunteers have participated in a key Phase 3 trial in the UK.
Extended to 15,000 participants
Full registration is expected until the end of November
Knowledge of the expected mid-term from the beginning of the first quarter of 2021
The Pivotal Phase 3 clinical trial in the US is expected to be in the UNITED States. U. S. Start until the end of November
Significant progress was made in large-scale production with some delays in the schedule
The company will provide knowledge of its ongoing Phase 1/2 clinical trial, adding new knowledge of phase 2 reactogenicity, at the cdc’s Advisory Committee on Immunization Practices (ACIP) public assembly on October 30
GAITHERSBURG, Maryland, October 27, 2020 (GLOBE NEWSWIRE) – Novavax, Inc. (Nasdaq: NVAX), a complex biogeneration company that will introduce next-generation vaccines for serious infectious diseases, has announced updates to its phase 3 clinical program of NVX-CoV2373 progression, its COVID-19 vaccine candidate. NVX-CoV2373 is a solid pre-fusion protein manufactured with Novavax nanoparticle generation and includes Novavax’s patented Matrix-M ™ adjuvant. The Company also announced that it will provide knowledge of its ongoing Phase 1/2 clinical trial, adding new knowledge of phase 2 reactogenicity, on Friday, October 30, on the Advisory Committee of the Center for Disease Control and Prevention. (CDC) Meeting on Immunization Practices (ACIP).
Phase 3 trial updated in the UK
To date, Novavax has recruited more than 5,500 trial participants in the UK, which has expanded to 15,000 volunteers. Increased recruitment is likely to facilitate the assessment of protection and effectiveness in a shorter period of time. which is fully recorded until the end of November and is based on the overall attack rate of COVID-19, provisional knowledge for this event-based trial in the early first quarter of 2021 is expected to serve as the basis for global authorization.
“We are pleased with the significant progress made in our Phase 3 clinical trial since its launch in the UK at the end of September,” Gregory M said. Glenn, MD, President of Research and Development at Novavax. “We are grateful for that of the UK Government Vaccine Working Group (VTF) and the National Institute for Health Research (NIHR) for our key trial Recognizing the recent and significant accumulation of COVID-19 cases in the UK, as well as immediate progress in recruiting participants in our trial, in consultation with VTF and NIHR , we have adjusted our plans and increased recruitment.
In accordance with Novavax’s commitment to transparency, the Company has published the protocol for this test in https://www. novavax. com/resources#protocols.
Update of the US phase clinical trial. But it’s not the first time
Lately, Novavax expects the critical clinical trial to begin in the United States and Mexico until the end of November. The company has made significant progress in large-scale manufacturing, with delays from the original calendar estimates.
Novavax has developed large-scale production processes in several centers around the world and plans to use the production of its production outsourced to FUJIFILM Diosynth Biotechnologies in Morrisville, North Carolina, as a component of this Phase 3 clinical trial.
Additional on the Phase 3 clinical trial
united kingdom
Novavax’s first critical Phase 3 clinical trial, to be conducted in September in partnership with the UK government’s Vaccine Working Group, will feature 10,000 to 15,000 volunteers, some of whom have been recruited through the National Health Service (NHS) Vaccine Registry. to give up knowledge once 152 participants have met mild, moderate or severe evaluation criteria. Two intermediate analyses are planned once 66 and 110 parameters have been reached.
United States / Mexico
Novavax’s fundamental Phase 3 clinical trial is being conducted with the US government. As a component of Operation Warp Speed. The test design is aligned with those of other giant corporations and requires the registration of up to 30,000 participants in the United States. and Mexico, with proportional representation among the various maximum populations vulnerable to COVID-19 divided by race/ethnicity, age and living population. The test protocol will be published on the Novavax online page at launch.
ACIP presentation Friday, October 30
Novavax Senior Vice President and Medical Director Filip Dubovsky, MD will provide an update at an ACIP CDC public assembly between 10:00 a. m. 12:30 p. m. ET Friday, October 30. For more information, visit www. cdc. gov/vaccines/acip/assemblys/index. html.
About NVX-CoV2373NVX-CoV2373 is a candidate vaccine designed from the genetic series of SARS-CoV-2, the virus responsible for the COVID-19 disease. NVX-CoV2373 was created using Novavax’s generation of recombinant nanoparticles to generate an antigen derived from the coronavirus spike protein (S) and comprises Novavax’s proprietary saponin-based Matrix-M ™ adjuvant for immune reaction and stimulating peak levels of neutralizing antibodies. NVX-CoV2373 comprises a purified protein antigen and cannot replicate or cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated the induction of antibodies that block the binding of the spike protein to targeted receptors throughout the virus, a critical facet for effective protection of the vaccine. In the Phase 1 portion of their Phase 1/2 clinical trial, NVX-CoV2373 was sometimes well tolerated and elicited physically powerful antibody reactions that were numerically staggering to those seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a phase 3 trial in the UK and two ongoing phase 2 studies that began in August; a phase 2b trial in South Africa and a continuation of phase 1/2 in the United States and Australia. Novavax has secured a $ 2 billion investment for its global coronavirus vaccine program, adding up to $ 388 million in investment from the Coalition for Innovations in Epidemic Preparedness (CEPI).
Novavax, Inc. (Nasdaq: NVAX) is a complex biogeneration company that promotes global fitness improvement through the discovery, progression and marketing of cutting-edge vaccines to prevent serious infectious diseases. Novavax is conducting clinical trials with NVX-CoV2373, its candidate vaccine for SARS-CoV-2, the culprit COVID-19 virus, NanoFlu ™, its tetravalent influenza vaccine, has achieved all the main objectives of its fundamental phase 3 clinical trial in the elderly. Both candidate vaccines incorporate Matrix-M ™ Patented by Novavax Immune Reaction Adjuvant and season the best grades of neutralizing antibodies. Novavax is one of the leading innovators of recombinant vaccines; its patented recombinant generation platform combines the strength and speed of genetic engineering to successfully produce superior immunogenic nanoparticles to meet urgent global fitness needs.
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Novavax Forward-Looking Statements
Statements herein relating to Novavax’s long term and continued progression of its vaccines and adjuvants are forward-looking statements. Novavax cautions that these forward-looking statements are subject to dangers and uncertainties, which may cause the actual effects to differ materially from those expressed or implied in those statements. These dangers and uncertainties come with those known under the heading “Risk Factors” in Novavax’s annual report on Form 10-K for the year ended December 31, 2019 and the quarterly report on Form 10-Q for the era that ended on June 30. 2020, as filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place significant reliance on the forward-looking statements contained in this press release. We inspire you to read our SEC filings, available at sec. gov, for a discussion of these and other dangers and uncertainties. The forward-looking statements in this press release speak only as of the date of this document and we do not assume any legal responsibility to update or revise any statement. Our business is subject to significant dangers and uncertainties, in addition to those mentioned above. Investors, potential investors, and others deserve to carefully consider these dangers and uncertainties.
Contacts: InvestorsErika Trahanir@novavax. com240-268-2022
MediaBrandzone / KOGS Communication Edna Kaplankaplan@kogspr. com 617-974-8659