Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.
Results showed that the CIC and flu vaccines generated “robust immune responses” across three flu strains (H1N1, H3N2 and B) and the SARS-CoV-2 strain in adults aged 65 and older. Per Novavax, these responses were similar to those seen with its own approved COVID-19 vaccine, Nuvaxovid, and Sanofi’s SNY influenza vaccine, Fluzone HD.
Novavax emphasized that this study was not designed to demonstrate statistical significance but to provide preliminary immunogenicity data. It intends to use these findings to design another late-stage study, which could potentially support regulatory submissions, if successful.
NVAX is also exploring strategic collaborations to finance further development and potential commercialization of both candidates. This is part of the company’s recent strategic shift focused on expanding its pipeline and exploring partnership opportunities for the same.
NVAX Stock Performance
Shares of Novavax have underperformed the industry year to date, as seen in the chart below.
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NVAX Stock: Recent Developments
The above announcement came just under a month after it received the long-awaited FDA approval for Nuvaxovid, albeit with a narrower label than initially expected. While the agency granted full approval to the vaccine for use in older adults aged 65 and above, it restricted the use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
This latest approval aligns with the FDA’s recently issued guidance for COVID-19 vaccine boosters. As part of this guidance, COVID vaccine makers will be required to conduct randomized, placebo-controlled clinical studies demonstrating the real-world benefit of yearly COVID vaccine boosters in individuals aged under 65 years.
Starting this year, Sanofi has acquired exclusive rights to market Nuvaxovid globally, except in certain territories where Novavax maintains existing partnership agreements. This arrangement is part of a multi-billion-dollar deal signed last year, wherein Sanofi assumed commercial responsibility for the vaccine. The company is also eligible for ongoing tiered royalties on future sales of COVID-19 vaccines.
Other Players Developing COVID-Flu Combination Shots
Apart from Novavax, Pfizer PFE and Moderna MRNA are also developing their respective COVID/flu combination vaccines using mRNA technology.
Despite the recent regulatory setback, Moderna remains ahead of its competitors with the development of its investigational COVID-19/flu vaccine candidate, mRNA-1083. Moderna had to voluntarily withdraw its FDA filing for mRNA-1083 to accommodate the agency’s request for additional efficacy data on the flu component of the vaccine. Moderna intends to resubmit the filing later this year.
Pfizer suffered a major setback in this space last year when it reported data from a phase III study on its investigational mRNA-based COVID-19/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. Pfizer is currently evaluating adjustments to its combination vaccine program to improve immune responses against influenza B and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.
Novavax’s deal with Sanofi also allows the latter to combine its own influenza vaccines with Nuvaxovid. Sanofi is currently testing multiple COVID-19/flu combination vaccine candidates under this arrangement. Last year, the FDA granted fast-track designation to two of Sanofi’s experimental combination vaccines, both being evaluated in separate phase I/II studies. While the first combination uses the Fluzone HD vaccine with Nuvaxovid, the second pairs Novavax’s COVID-19 shot with Flubok.
Novavax, Inc. Price
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NVAX’s Zacks Rank
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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This article originally published on Zacks Investment Research (zacks.com).
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