Novavax NVAX announced that it has started dosing participants in the phase III study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.

The study will compare the immunogenicity and safety of the CIC vaccine with separate administrations of Novavax’s currently authorized COVID-19 vaccine and a licensed seasonal influenza vaccine. Management will also assess the immunogenicity and safety of its standalone influenza vaccine.

Both experimental vaccines will utilize the company’s proprietary adjuvant technology, Matrix-M, to enhance the immune response. The study will focus on adults aged 65 and older.

Novavax is in active discussions with the FDA for accelerated approval for both vaccines. Though more clarity on these discussions is expected in the second quarter of 2025, management has decided to enroll nearly 2,000 study participants in an initial cohort of the study.

NVAX is also exploring strategic collaborations to finance the late-stage development and potential commercialization of both candidates.

This initiation is supported by data from a mid-stage study, which showed that both vaccines were well-tolerated and generated robust immune responses when compared with authorized comparators like Novavax’s own COVID-19 vaccine and influenza vaccines Fluzone HD and Fluad, marketed by Sanofi SNY and CSL Seqirus’ Fluad, respectively.

NVAX Stock Performance

Year to date, Novavax’s shares have soared 82.7% against the industry’s 7.3% decline.

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NVAX’s Recent Developments

The announcement was made just a month after the FDA lifted the clinical hold on the CIC and influenza vaccines. The agency had initially placed this hold in October after a study participant who took the CIC shot as part of a phase II study reported nerve damage.

In May, Novavax signed a multi-billion dollar deal with pharma giant Sanofifor its protein-based COVID-19 vaccine. Starting next year, Sanofi will market the company’s COVID-19 vaccine and use it to develop novel COVID-19-influenza combination vaccines. As part of this deal, NVAX received a payment of $570 million from SNY, including $70 million in equity investment. Novavax is also eligible to receive milestone payments of up to $700 million and royalties on sales of the COVID-19 vaccine from Sanofi.

The agreement permits both companies to develop their respective combined COVID-19-influenza combination vaccines and adjuvanted products at their own cost.

Other Players Developing COVID-Flu Combination Shots

Apart from Novavax, pharma giants like Pfizer PFE and Moderna MRNA are also developing their respective COVID/flu combination vaccines using mRNA technology. Both peers are way ahead of NVAX as their candidates are in late-stage development.

Moderna is ahead of all its competitors in the COVID/flu combination space. In June, MRNA reported positive results from a late-stage study on mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19, in older adults (50 years and above). This study met its primary endpoints, showing that mRNA-1083 elicited higher immune responses against influenza and COVID-19 than licensed standalone influenza and COVID-19 vaccines.

Based on these results, MRNA intends to submit a regulatory filing seeking approval for mRNA-1083 before the end of this year, subject to ongoing discussions with the FDA. It aims to market the vaccine next year.

Pfizer suffered a major setback in this space a few months back when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. PFE 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.

A recent entrant into this space is Sanofi, which is also developing its own COVID/flu combination vaccines. Earlier today, SNY announced that the FDA has granted fast-track designation to two of its experimental combination vaccines for COVID-19 and influenza, each being evaluated in separate phase I/II studies. While the first combination pairs the Fluzone HD vaccine with Novavax’s COVID-19 vaccine, the second combines Sanofi’s Flubok influenza vaccine with the NVAX COVID-19 vaccine.

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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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