The company is also evaluating its standalone seasonal influenza vaccine.


RT’s Three Key Takeaways:

  1. Novavax has begun a phase 3 trial evaluating both its COVID-19-influenza combination vaccine and a standalone seasonal influenza vaccine in adults aged 65 and older.
  2. The trial aims to assess the immunogenicity and safety of the vaccine candidates compared to Novavax’s updated COVID-19 vaccine and a licensed seasonal influenza vaccine.
  3. Novavax is working with the FDA to explore the possibility of an accelerated approval pathway, with an initial cohort of 2,000 participants being recruited for the trial.

Novavax Inc announced that the first participants have been dosed in its COVID-19-influenza combination and standalone seasonal influenza phase 3 trial. 

The trial will evaluate the immunogenicity and safety of the COVID-19-influenza combination and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

“A combination vaccine for two vaccine-preventable diseases is an important step forward for public health, and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships,” says Ruxandra Draghia-Akli, MD, PhD, executive vice president and head of research and development at Novavax, in a release. “Our goal is to get these assets to market as soon as possible, and we will work with the US FDA to assess the possibility of an accelerated approval pathway.”

Seeking Accelerated Approval

The company is working with the US Food and Drug Administration (FDA) to determine the potential of the current COVID-19-influenza combination and stand-alone influenza trial to support accelerated approval. While in the process of seeking alignment on accelerated approval criteria with the FDA, Novavax has decided to recruit an initial cohort of approximately 2,000 participants while continuing this dialogue. 

Novavax anticipates being able to provide more clarity and information on potential next steps by Q2 2025, including if additional clinical work would be needed to achieve registration for these assets.

The randomized phase 3 trial builds on positive phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax’s updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant relative to separate administrations of Novavax’s updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine comparator. 

In addition, the trial also aims to further evaluate the immunogenicity and safety of Novavax’s stand-alone influenza vaccine, also containing Matrix-M.

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