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Phase 2b trial in collaboration with Professor Shabir Madhi and the University of Wits
The Bill Foundation
Mature infrastructure and significant degrees of seasonal transmission can enable immediate assessment of effectiveness.
GAITHERSBURG, Maryland, August 17, 2020 (GLOBE NEWSWIRE) – Novavax, Inc.(NASDAQ: NVAX), a complex biotechnology company that will present next-generation vaccines for serious infectious diseases, announced the start of a Phase 2b clinical trial in South Africa to compare the effectiveness of NVX-CoV2373, Novavax COVID-19.Dr’s candidate vaccine. Shabir Madhi, a professor of vaccination at the University of Wits, will lead the clinical trial, which is funded in one component through a $15 million grant from the Bill Foundation.
“Because South Africa is experiencing a winter outbreak of COVID-19 disease, this vital Phase 2b clinical trial has the potential to provide early indication of efficacy as well as increased protection and immunogenicity for NVX-CoV2373,” Gregory M said.GlennArray MD, President of Research and Development at Novavax.”We appreciate the continuation of the Bill Foundation
The randomized, blinded, placebo-controlled phase 2b clinical trial on NVX-CoV2373 will consist of two cohorts: one cohort will assess efficacy, protection, and immunogenicity in approximately 2,665 healthy adults, and the cohort for now will assess protection and immunogenicity in approximately 240 medically sound Adults with HIV. This allows the vaccine to be evaluated in a diverse and representative study population. Novavax anticipates that if approved in South Africa, its COVID-19 vaccine will be provided to South Africa through Novavax’s recently announced collaboration with the Serum Institute. from India.
“The main motivation for COVID-19 vaccines to be evaluated at an early level in South Africa is to generate evidence in the African context about how coVID-19 vaccines work in contexts like ours,” said Shabir Madhi, MBBCH, FCPaeds, Ph.Re.” I am very happy to work with Novavax as lead researcher in this clinical trial, following the knowledge of Phase 1 of the Novavax COVID-19 vaccine, which provides a solid justification for advancing progression in a wider subset of adults.”
In Phase 1 of the Phase 1/2 clinical trial in Australia, NVX-CoV2373 was well tolerated and provoked numerically amazing physically powerful antibody responses than those observed in convalescent human serums.This knowledge has been sent to the U.S. Food and Drug Administration.FDA and an independent protection oversight committee, and has also been peer-reviewed in a clinical journal and published online on the prepress server medRxiv.org.Novavax intends to launch Phase 2 of this trial in the United States and Australia in this trial will come with approximately 1,500 subjects and come with older adults.
The Coalition for Innovations in Epidemic Preparedness (CEPI) is investing in the manufacture of NVX-CoV2373 doses for this Phase 2b assay.
About NVX-CoV2373
NVX-CoV2373 is a candidate vaccine founded on the genetic series of SARS-CoV-2, the virus guilty of COVID-19 disease.NVX-CoV2373 was created using Novavax recombinant nanoparticle generation to generate an antigen derived from the coronavirus peak protein (S) and comprises the Matrix-M adjuvant ™ patented by Novavax saponin for immune reaction and stimulate maximum levels of neutralizing antibodies.In preclinical trials, NVX-CoV2373 demonstrated antibodies that block the link of complex protein with receptors directed through the virus, In its knowledge of Phase 1/2 clinical trial, NVX-CoV2373 was sometimes well tolerated and caused numerically amazing physically potent antibody reactions than those observed in convalescent human serums.2 clinical trials will begin in August. Novavax has secured a $2 billion investment for its global coronavirus vaccine program, totaling $388 million in investment from the Coalition for Innovations in Epidemic Preparedness (CEPI).
About Matrix-M ™
The patented Matrix-M adjuvant ™ based on Novavax’s saponin has demonstrated a powerful and well-tolerated effect by stimulating the access of antigen-presenting cells to the injection and editing the presentation of antigens in local lymph nodes, stimulating the immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a complex biogeneration company that promotes global fitness through the discovery, progression and commercialization of state-of-the-art vaccines to prevent serious infectious diseases. Novavax is in clinical trials with NVX-CoV2373, its candidate vaccine for SARS-CoV-2, the culprit virus of COVID-19, NVX-CoV2373 was sometimes well tolerated and provoked numerically amazing physically powerful antibody reactions that those observed in human convalescent serums in its knowledge of Phase 1 Phase 1/2 NanoFlu clinical ™, its tetravalent influenza vaccine, has achieved all the main objectives of its fundamental Phase 3 clinical trial in the elderly.Novavax neutralizing antibodies 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 premium immunogenic nanoparticles to meet urgent global fitness needs.
For more information, visit www.novavax.com and join us on Twitter and LinkedIn.
Novavax Forward-Looking Statements
The statements in this document relating to Novavax’s long term and continued progress 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 8-K 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 any 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:
Novavax
Investors Silvia Taylor and Erika Trahanir@novavax.com240-268-2022
MediaBrandzone / Speak Life ScienceAmy Speak amy@speaklifescence.com 617-420-2461