GAITHERSBURG, Md. - Novavax , Inc. (NASDAQ:NVAX) has announced the availability of its new COVID-19 vaccine formulation, designed to target the JN.1 variant, at pharmacies nationwide. The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is now in stock at major pharmacy chains and thousands of independent pharmacies across the United States, providing a protein-based immunization option for individuals aged 12 and older.
This updated vaccine, which also offers protection against related strains such as KP.2.3, KP.3, KP.3.1.1, and LB.1.1, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on August 30, 2024. Novavax's President and CEO John C. Jacobs emphasized the company's efforts to improve accessibility by increasing the number of locations offering the vaccine and by providing it in a pre-filled syringe format.
The Novavax vaccine is the only protein-based COVID-19 vaccine available this fall in the U.S. Unlike mRNA vaccines, it uses a recombinant nanoparticle technology to create copies of the spike protein found on the surface of the SARS-CoV-2 virus, which causes COVID-19. The inclusion of Novavax's patented Matrix-M adjuvant aims to enhance the immune response.
While the vaccine has been authorized for emergency use, it has not yet received full FDA approval. It is indicated for active immunization against COVID-19 and is contraindicated for individuals with a history of severe allergic reactions to any component of the vaccine. The vaccine's safety information also includes warnings about increased risks of myocarditis and pericarditis, as well as precautions for immunocompromised individuals and those with altered immunocompetence.
Novavax's updated vaccine comes in a ready-to-use liquid formulation that can be stored at standard refrigeration temperatures, facilitating distribution using existing supply chains. Healthcare providers administering the vaccine are required to report any adverse events to the Vaccine Adverse Event Reporting System (VAERS).
The information in this article is based on a press release statement from Novavax, Inc.
In other recent news, Novavax, Inc. has received Emergency Use Authorization from the U.S. Food and Drug Administration for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 and older. This decision aligns with recommendations from the U.S. Centers for Disease Control and Prevention. The vaccine, targeting the JN.1 strain, will be available at various locations, including retail pharmacies and regional grocers.
In financial developments, Novavax reported Q2 2024 revenue of $415 million, largely due to a significant partnership with Sanofi (NASDAQ:SNY). The company plans cost reductions and a more efficient R&D model for 2025 and beyond, while preparing for the upcoming U.S. vaccination season with plans to launch its updated COVID-19 vaccine in select European markets.
Novavax is also renegotiating or exiting Advance Purchase Agreements for vaccine distribution and exploring the sale of its Czech Republic manufacturing facility to further reduce operating costs. The company anticipates total revenue of between $700 million and $800 million for the full year 2024, with the majority of product sales expected in Q4. These recent developments highlight Novavax's strategic focus on cost reduction, efficiency, and innovative partnerships.
InvestingPro Insights
As Novavax, Inc. (NASDAQ:NVAX) rolls out its new COVID-19 vaccine formulation targeting the JN.1 variant, the company's financial standing and market performance provide additional context for investors. With a market capitalization of $1.95 billion, Novavax is navigating a challenging period marked by a significant sales decline of 38.17% in the last twelve months as of Q2 2024.
An InvestingPro Tip worth noting is that Novavax holds more cash than debt on its balance sheet, which could provide a cushion against the current sales downturn. However, analysts have tempered their expectations, with two analysts revising their earnings downwards for the upcoming period and anticipating the company will not be profitable this year.
Despite these challenges, Novavax has experienced a large price uptick over the last six months, with a 127.05% total return, signaling potential investor confidence in the company's long-term prospects. Additionally, the stock's volatility could present opportunities for investors; the company's shares have seen a year-to-date price total return of 148.33%.
Investors should also take note of the company's price-to-earnings (P/E) ratio, which stands at -5.31, reflecting the market's current skepticism about future earnings. Moreover, Novavax does not pay a dividend, which may influence the investment strategies of income-focused shareholders.
For those seeking more in-depth analysis, InvestingPro provides a wealth of additional tips and metrics on Novavax, which can be found at https://www.investing.com/pro/NVAX.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.