Novavax (NVAX) Stock Soars On Positive Vaccine Data

Novavax, Inc (NASDAQ: NVAX) is screaming for the top in the premarket hours this morning after the company released positive data from a Phase 3 trial of its COVID-19 vaccine candidate. Here’s what’s happening:

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NVAX Climbs On COVID-19 News

In the press release, Novavax said that its NVX-CoV2327 nanoparticle protein-based COVID-19 vaccine demonstrated some impressive results in Phase 3 studies. First and foremost, the vaccine proved to be 100% effective against moderate and severe disease. Moreover, the overall efficacy rate of the vaccine was 90.4%, meeting the primary endpoint of the PREVENT-19 clinical trial. 

The company went on to explain that there were 29,960 patients enrolled in the study across 119 sites in the United States and Mexico. The study was designed to evaluate efficacy, safety, and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the pandemic. 

Considering the overwhelmingly positive data, NVAX said that it plans on filing for regulatory authorizations in the third quarter. This will take place following the completion of the final phases of process qualification and assay validation needed to meet CMC requirements. 

The company also said that upon the approval of the vaccine, it remains on track to reach a manufacturing capacity of 100 million doses per month at the end of the third quarter and 150 million doses per month by the end of the fourth quarter of this year. 

Management Commentary

In a statement, Stanley C. Erck, President and CEO at NVAX, had the following to offer:

Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection. Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.

The above statement was followed up by Gregory M. Glenn, M.D., President of R&D at Novavax. Here’s what he had to say:

PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.

This Is Exciting News

Ultimately, the news released by NVAX is overwhelmingly exciting. First and foremost, there is still a very large portion of the global population that hasn’t received their first doses of any COVID-19 vaccine. As such, if approved, there will likely be high demand for the vaccine out of the gate. 

Moreover, experts suggest that current COVID-19 vaccines will have to be followed up with booster shots on an annual or semi-annual basis. As a result, demand for the vaccine may prove to be strong for the long haul. 

At the same time, Novavax is well positioned to take advantage of the strong demand, with plans to produce more than 100 million doses per month. As a result, should the vaccine be approved, the company has the potential to generate tremendous revenue and profitability. 

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The Bottom Line

The bottom line here is simple. With the results of the Phase 3 trial being so positive, the company is likely to realize the fruits of its labor relatively soon. As a result, investors can look forward to potentially significant revenue and profitability in the near future. All in all, NVAX is one for the watchlist. 

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