13.03.2021 – 04:39
Gaithesburg, Maryland (ots / PRNewswire)
– 100% protection against serious diseases
– Final analysis in a British study confirms 96% efficacy against the original strain of COVID-19
– Performance against variations in Great Britain and South Africa was confirmed
Novavox, Inc., a biotechnology company that develops next-generation vaccines for serious infectious diseases. (Nasdaq: NVX), the company announced today the final efficacy of its vaccine candidate NVX-Cowie 2373, in a major phase study known in the UK at 96.4%. Against mild, moderate and severe diseases caused by the original COVID-19 strain. The company also announced the full analysis of its second phase study in South Africa. The efficacy among participants in the HIV-negative study was 55.4%, where the majority of strains were B1.351 escape types. In both studies, NVX-Cowie 2373 demonstrated 100 percent protection from serious illness, including all hospitalizations and deaths. Both studies met their statistical success criteria. Today’s final analysis generates successful interim results obtained in January 2021 Announced, Add more COVID-19 cases and statistical power.
“We are very encouraged by the data that NVX-Cowie 2373 not only provides complete protection against the most severe forms of the disease, but also dramatically reduces mild and moderate disease in both studies. Importantly, both studies are effective against.” Stanley C., President and CEO of NovaVox. Said Erk. “It’s been a year since the WHO officially declared the COVID – 19 epidemic, and with this data at hand, we are still motivated to develop our vaccine as a viable weapon in the fight against the effects of COVID – 19.”
UK Phase III Study
More than 15,000 participants between the ages of 18 and 84 participated in the study, 27% of whom were over 65 years of age. The primary point of the third phase clinical trial in the UK is based on the first occurrence of PCR-confirmed symptom (mild, moderate or severe) COVID-19, the second study is at least 7 days after vaccination with serological negative (based on SARS) -COV-2) Adult participants at the beginning of their study.
Efficiency against the original virus strain was 96.4% (95% CI: 73.8, 99.5) and against variant B. 1.1.7 / 501Y.V1 (Post Hog) 86.3% (95% CI: 71.3, 93.5). The primary performance endpoint showed an overall vaccine efficacy of 89.7% (95% CI: 80.2, 94.6). 106 cases were found, 10 in the vaccine group and 96 in the placebo group. NVX-CoV2373 was effective against acute disease: five acute 1 cases were found in the study and all occurred in the placebo group. Four of the five severe cases were diagnosed from the B.1.1.7 / 501Y.V1 variant. Fourteen days after dose 1, the vaccine efficacy was 83.4% (95% CI: 73.6, 89.5).
10 cases of COVID-19 were found in subjects 65 years of age and older, of which 90% of cases occur in the placebo group. Older adults and groups with a higher risk of developing COVID-19 have a higher risk of complications.
Novavox expects the data to serve as a basis for submitting regulatory applications to various regulatory agencies around the world.
South African Phase IIb Study
The South African study was a randomized, observer-blind, placebo-controlled clinical phase IIb study with NVX-CoV2373. A partner surveyed the efficacy, safety, and immunity of approximately 2,665 healthy adults. The second partner studied the safety and immunity of approximately 240 clinically stable, HIV-positive adults.
The full efficacy analysis of the vaccine in 147 PCR positive cases (51 cases in the vaccine group and 96 cases in the placebo group) showed an overall efficacy of 48.6% against mainly different strains (95% CI: 28.4, 63.1). Most of the cases that spread during performance analysis were due to the variant B.1.351 / 501Y.V2 circulating in South Africa. All five cases of acute illness found in the study occurred in the placebo group. Among HIV-negative participants, 55.4% performance was observed (95% CI: 35.9, 68.9). The full analysis showed that vaccine-induced protection began 4 days after dose 1 (42.7% 95% CI: 25.0, 56.3), although increased efficacy was observed 7 days after dose 2, which was the primary focus of the study.
The initial report of the study 60 days ago suggested that a previous infection with the original COVID-19 strain may not fully protect against subsequent infections with the variant spreading widely in South Africa. However, a full analysis of the South African study suggests that a delayed protective effect may have occurred prior to exposure to the original COVID-19 strain. Among placebo recipients, the incidence rate after 90 days was 7.9% in seronegative subjects and 4.4% in seropositive subjects.
In both UK and South African studies, these analyzes showed that the vaccine was well tolerated, with a low rate of acute, chronic, acute (SAEs) and clinically related adverse events on day 35, balancing between vaccine and placebo groups.
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Information about NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate, derived from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-Covey 2373 was developed using novovax reconstitution nanoparticle technology to develop an antigen derived from the corona virus spike (S) protein, and is based on the novax vaccine-based saponin-binding (novax) patented to enhance immunity and induce high levels of neutral antibodies. . NVX-CoV2373 contains purified protein antigen and cannot duplicate or cause COVID-19. In preliminary studies, NVX-Cowie induced 2373 antibodies that inhibit the binding of spike protein to cellular receptors and provide protection against infections and diseases. It is generally well tolerated and exhibits a strong antibody response, which is better in number on stage I / II clinical trials than those found in human curing sera. NVX-CoV2373 is being explored in two major phase studies, with one study in the UK showing 96.4% efficacy against the original virus strain and 89.7% overall, and the PREVENT-19 study in the United States and Mexico, launched in December 2020. In addition, it is being tested in two phase studies beginning in August: a phase II study in South Africa, which showed a 48.65% efficacy against the variance of the growing escape, and a phase II study in South Africa. I / II series in the United States and Australia.
NVX-CoV2373 is stored at 2 ° – 8 C and is stable so that the current channels of the vaccine supply chain can be used for distribution. It is packaged in ready-to-use liquid formulations in 10-dose vials.
Information about Matrix-M (TM)
NovaVox’s patented saponin-based Matrix-M (TM) supplement has shown a powerful and well-tolerated effect by stimulating the entry of antigen-delivering cells into the injection site and increasing antigen presentation at local lymph nodes.
Information about Novavox
Novavox, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health worldwide through the invention, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s own restorative technology platform combines the energy and speed of genetic engineering to effectively produce highly immune nanoparticles that address urgent global health needs. NovaVox is currently undergoing late clinical trials for NVX-CV2373, a vaccine candidate for the virus SARS-CoV-2, which causes the COVID-19 virus. The nanoflu (TM), a four-fold nanoparticle-based flu vaccine, has achieved all the primary goals in a major tertiary clinical trial in the elderly and is preparing to file for regulation. Both vaccine candidates have a subgroup based on NovaVox’s proprietary matrix-M (TM) saponin, which enhances immunity and induces high levels of neutral antibodies.
Forward-looking reports from NovaVox
The reports in this document regarding the future of NovaVox and the current development of its vaccine and by-products are perspective statements. Novak warns that these perspective statements are subject to numerous risks and uncertainties, which may or may not differ from the actual results revealed in these statements. These risks and uncertainties are set out in NovaVox’s annual report on Form 10-K for the year ending 31 December 2020 under the heading “Risk Factors” and are filed with the Securities and Exchange Commission (SEC). We warn investors not to place unnecessary credibility in the perspective statements in this press release. We encourage you to read our SEC filings available at sec.gov to learn about these and other risks and uncertainties. The forward-looking statements in this press release speak only from the date of this document, and we consider that there is no obligation to update or edit these statements. Our business is subject to significant risks and uncertainties, including the above. Investors, potential investors and others should carefully consider these risks and uncertainties.
The final point definitions for the severity of COVID-19 can be found in the study protocols https://www.novavax.com/resources#protocols
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