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GAITHERSBURG, MD., August 30, 2021 / PRNewswire / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company that develops next-generation vaccines against serious infectious diseases, today announced that the state Centers for Disease Control and Prevention (CDC) United have provided updated guidance to those who have been vaccinated in a clinical trial in the United States CDC guidance indicates that participants in the Novavax PREVENT-19 phase 3 clinical trial meet the criteria for be considered fully vaccinated two weeks after completing the vaccination series.
“Novavax commends the CDC for its continued support of volunteers in the COVID-19 clinical trials, with this update providing clarification and guidance to participants in our PREVENT-19 Phase 3 clinical trial,” said Gregory M. Glenn, MD, president of research and development, Novavax. “We are grateful to all of our clinical trial participants who have helped create a safer future for all.”
As part of its general guidelines for COVID-19 vaccines, the CDC’s website has been updated to include the following section, which is aimed specifically at participants in the Novavax PREVENT-19 trial:
“People vaccinated against COVID-19 as part of a clinical trial in United States
Some people in United States have completed a series of COVID-19 vaccinations in a US-based clinical trial involving a COVID-19 vaccine that is not currently cleared by the FDA.
People who have received the full set of an active COVID-19 vaccine candidate in a US-based clinical trial of a COVID-19 vaccine that is neither FDA cleared nor listed for use emergency by WHO
If it has been proven that a participant in a US-based clinical trial has received the full set of an “active” COVID-19 vaccine candidate (not a placebo) and the vaccine’s efficacy has been confirmed independently (for example, through a data and safety chart check), the participant can be considered fully vaccinated 2 weeks after completing the series of vaccines. Currently, the Novavax COVID-19 vaccine meets these criteria. This does not mean that the vaccine has been cleared by the FDA or that it is recommended by the CDC or ACIP.
Participants in the Novavax clinical trial who have not received the full 2-dose series of the active COVID-19 vaccine candidate should be advised by trial investigators to follow current prevention measures to protect against COVID-19 and offered a series of COVID-19 vaccines cleared by the FDA. “
PREVENT-19, the Novavax study to evaluate the safety and efficacy of the company’s recombinant nanoparticle protein vaccine, NVX-CoV2373 with Matrix-M ™ adjuvant, demonstrated an overall efficacy of 90% and 100% protection against moderate and severe disease.
For more information, please see “Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in United States’ page here or Novavax.com.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with the patented Matrix-M ™ adjuvant based on saponin from Novavax to improve the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate or cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of the spike protein to cell receptors and provided protection against infection and disease. It was generally well tolerated and elicited a strong antibody response in phase 1/2 clinical trials.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a UK trial that demonstrated 96.4% efficacy against the original viral strain, 86.3% against the Alpha variant (B.1.1 .7) and an overall efficiency of 89.7%; and the PREVENT-19 trial in the United States and Mexico which demonstrated 100% protection against moderate and severe disease and an overall efficacy of 90.4%. It is also being tested in two ongoing phase 2 studies that began in August 2020: a phase 2b in South Africa which demonstrated an overall efficacy of 55% in HIV-negative participants and an efficacy of 48.6% against a newly emerging escape variant first described in South Africa, and a continuation of phase 1 / 2 in the United States and Australia.
NVX-CoV2373 is stored and stable at 2 ° to 8 ° C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10 dose vials.
About Matrix-M ™ Adjuvant
Novavax’s patented saponin-based Matrix-M ™ adjuvant has been shown to have a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and improving antigen presentation in the injection site. local lymph nodes, thereby strengthening the immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. Novavax is conducting advanced clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, its quadrivalent nanoparticle influenza vaccine, has met all of the primary goals of its pivotal Phase 3 clinical trial in the elderly and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
Forward-looking statements
The following statements concerning the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and its partnerships, and other Novavax vaccine candidates, the timing of future filings and regulatory actions , and the role Novavax can play in helping control the COVID-19 pandemic 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 these statements. These risks and uncertainties include the challenges of meeting, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and test validation, necessary to meet applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to follow planned regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government and other entities; and the other risk factors identified in the “Risk factors” and “Management’s analysis and analysis of the financial position and operating results” sections of Novavax’s annual report on Form 10-K for the financial year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on any forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this document, and we assume no obligation to update or revise any such statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
[email protected]
Solebury Trout
Alexandra Roy | 617-221-9197
[email protected]
Media
Laura Keenan | 202-709-7521
Ali Chartan | 202-720-7804
[email protected]
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SOURCE Novavax, Inc.
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