Maryland-based Novavax NVAX is engaged in developing innovative vaccines to prevent serious infectious diseases. Although the company is yet to generate revenues from product sales, the vaccine pipeline development shows promise.
It mainly generates revenues via performing services under the agreement with the Coalition for Epidemic Preparedness Innovations and participation in the U.S. government’s Operation Warp Speed in relation to the clinical development of the company’s COVID vaccine, NVX-CoV2373.
Currently, it is evaluating vaccine candidates in late-stage studies for three different indications - COVID-19, seasonal influenza and respiratory syncytial virus (“RSV”).
In June, the company announced data from the phase III PREVENT-19 study, which evaluated its COVID vaccine, NVX-CoV2373, in the United States and Mexico. The study met its primary endpoint by demonstrating an overall vaccine efficacy of 90.4%. It also demonstrated 100% protection against moderate and severe disease, which indicates a key secondary endpoint.
The vaccine has shown to be effective against strains of the coronavirus first found in the U.K. (Alpha), Brazil (Gamma), South Africa (Beta) and India (Delta).
The company filed a regulatory application to the World Health Organization (“WHO”) for the emergency use listing (EUL) of its COVID-19 vaccine to nations participating in the COVAX facility in September. Currently, WHO has granted EUL to the COVID vaccines developed by AstraZeneca AZN, Moderna MRNA and Pfizer PFE/BioNTech, which supplied millions of doses across the world.
The company has also partnered with Serum Institute of India, the world’s largest vaccine producer, to jointly supply 1.1 billion doses of NVX-CoV2373 to countries participating through the COVAX facility. Novavax also filed regulatory filings for the emergency use of its vaccine in multiple markets including India, Indonesia and the Philippines.
Yet, Novavax is delaying its regulatory filings for the COVID vaccine in both the United States and EU. While the company has already delayed its filings in the United States twice to fourth-quarter 2021, it is yet to announce plans for filings in the U.K. and the EU following a delay from its original scheduled timeline in third-quarter 2021.
In March 2020, Novavax announced positive top-line data from a pivotal phase III study, which demonstrated both efficacy and safety of its seasonal influenza vaccine, NanoFlu. The study met all primary goals and achieved a statistical significance with key secondary endpoints. The company will file a regulatory application in the United States shortly.
Last month, it initiated patient enrollment in a phase I/II study to evaluate a combination of its COVID-19 vaccine candidate and the seasonal influenza vaccine candidate.
ResVax, the potential RSV vaccine developed by the company, is being evaluated in a phase III study to protect infants by immunizing their mothers against the disease. It is also being investigated in phase II and phase I studies to address older adults and the pediatric patient population, respectively, for the given indication.
While the lack of any marketable drug in the company’s portfolio remains a woe, Novavax’s pipeline progress keeps the stock afloat. Potential approval of any of the pipeline candidates will boost both the stock price and revenue prospects of Novavax.
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