Novavax, Inc. NVAX announced that it has initiated the first phase III study in the United Kingdom evaluating the safety, efficacy and immunogenicity of its COVID-19 vaccine candidate NVX-CoV2373.
It is being conducted in partnership with the UK Government’s Vaccines Taskforce and is expected to enroll around 10,000 individuals aged between 18 years and 84 years regardless of any relevant comorbidity over the next four to six weeks.
Data from this study is likely to support the regulatory submissions for licensure of the vaccine in the United Kingdom, the EU and other countries.
Shares of Novavax were up 7.3% in after-hours trading on Thursday following the aforementioned news. In fact, the stock has skyrocketed 2473.8% so far this year against the industry’s decrease of 0.1%.
We note that NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix M adjuvant. The vaccine candidate is currently being evaluated in several phase II studies. Data from an early-stage study showed that NVX-CoV2373 was generally well tolerated and produced high levels of antibodies against the novel coronavirus.
Notably, in August 2020, Novavax signed a Heads of Terms (Term Sheet) with the government of the United Kingdom to supply 60 million doses of NVX-CoV2373. The company also reached an agreement in principle with the Canadian government, which is looking to purchase up to 76 million doses of its COVID-19 vaccine candidate.
Meanwhile, in the same month, Novavax enrolled the first volunteer in the phase II portion of its ongoing phase I/II study, which is evaluating the immunogenicity and safety of NVX-CoV2373. The study will recruit up to 1,500 healthy volunteers in the United States and Australia with approximately 50% patients aged between 60 years and 84 years.
Novavax is one of the dozen companies developing a vaccine for the deadly coronavirus disease. Several big companies, such as AstraZeneca AZN /Oxford University, Pfizer PFE along with its Germany-based partner BioNTech and Moderna MRNA already initiated their phase III studies on their respective COVID-19 vaccine candidates. Against the current backdrop, we expect this rush to get a regulatory nod approval for a potential COVID-19 vaccine to intensify in the upcoming months.
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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