Biotechnology company Novavax Inc. (NVAX:NASDAQ), which is focused on developing next-generation vaccines to address serious infectious diseases, yesterday announced that "NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (U.K.)."
The firm advised that the study was conducted during the time when COVID-19 transmission was high and a new U.K. variant strain of the virus had emerged and begun to circulate widely. Novavax stated the Phase 3 trial was carried out in partnership with the U.K. Government's Vaccines Taskforce. The company added that it also obtained successful results in its Phase 2b study in South Africa.
The company's President and CEO Stanley C. Erck commented, "With today's results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants."
The firm stated that "NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax' recombinant nanoparticle technology and the company's proprietary saponin-based Matrix-M™ adjuvant." The company indicated that the purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is stable at 2°C to 8°C. It requires only standard refrigeration and is shipped in a ready-to-use liquid formulation.
The company explained that U.K. study enrolled more than 15,000 people ranging from the ages of 18 to 84 with 27% of them being over 65 years of age. The firm noted that the pre-determined primary endpoint in the UK Phase 3 clinical study was established as "the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline."
Novavax reported that the first interim analysis presented is based upon 62 participant cases. The data for these patients showed that 56 cases of COVID-19 were observed in the placebo group, compared to just 6 cases in the NVX-CoV2373 group. Based upon this data, the company stated that this demonstrates a point estimate of vaccine efficacy of 89.3%.
The firm noted that the preliminary analysis indicates that the UK variant strain was increasingly prevalent and detected in over 50% of the PCR-confirmed symptomatic cases, and pointed out that "based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain."
Clive Dix, chair of the U.K. Vaccine Taskforce, remarked, "These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging."
The company additionally discussed the results obtained in the South Africa Phase 2b clinical study. This trial, which began in August of last year, included more than 4,400 patients. During the course of this trial the firm noted that the triple mutant virus variant was widely circulating in South Africa. The company stated that the data from this study "suggests that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection."
Professor Shabir Maddi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits and principal investigator in the Novavax COVID-19 vaccine trial in South Africa, remarked, "The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa."
Novavax reported that it expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new U.K and South African strains in the coming days and plans to start testing them clinically in Q2/21.
Novavax' President of Research and Development Gregory M. Glenn, M.D., commented, "A primary benefit of our adjuvanted platform is that it uses a very small amount of antigen, enabling the rapid creation and large-scale production of combination vaccine candidates that could potentially address multiple circulating strains of COVID-19."
Novavax is a biotechnology company headquartered in Gaithersburg, Md. The firm states that it uses its proprietary recombinant nanoparticle vaccine technology to discover, develop and commercialize novel vaccines designed to prevent serious infectious diseases. The company's product pipeline includes clinical vaccine candidates for COVID-19, respiratory syncytial virus, seasonal influenza, Ebola virus, middle east respiratory syndrome, severe acute respiratory syndrome and other infectious diseases.
Novavax started off the day with a market capitalization of around $8.5 billion with approximately 63.66 million shares outstanding and a short interest of about 11.0%. NVAX shares opened more than 40% higher today at $191.05 (+$57.04, +42.56%) over yesterday's $134.01 closing price and reached a new 52-week high this morning of $235.50. The stock traded today between $172.00 and $235.50 per share and closed today at $220.94 (+$86.93, +64.87%).[NLINSERT]
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