Novavax initiates phase 2 combination COVID-19/flu vaccine study

Novavax has announced the initiation of a phase 2 trial for its combination COVID-19/influenza and stand-alone influenza vaccine candidates.

The randomised, observer-blind trial will evaluate the safety and effectiveness of different formulations of the company’s recombinant protein-based COVID-19 vaccine, quadrivalent influenza vaccine candidate and patented saponin-based Matrix-M adjuvant in adults aged 50 to 80 years.

Initial results from the trial, which is expected to enrol around 2,300 participants across sites in Australia and New Zealand, are expected towards the middle of the year. This data will inform the phase 3 trials for both influenza stand-alone and COVID-19/influenza combination candidates, the company said.

Stanley Erck, president and chief executive officer, Novavax, said: "We're encouraged by the initiation of this trial given the positive results shared [last] year from our phase 1/2 trial, the first of its kind to evaluate a combined COVID-19 and influenza vaccine.

"We believe that, like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID-19.”

Novavax announced positive phase 1/2 results for its combination COVID-19/influenza vaccine candidate in October 2022, which demonstrated the vaccine’s ability to generate immune responses against SARS-CoV-2 and homologous and heterologous influenza strains.

In November 2022, Pfizer and BioNTech also initiated a phase 1 study of their mRNA-based combination COVID-19/influenza vaccine.

The vaccine combines Pfizer’s quadrivalent modified RNA-based influenza vaccine candidate, currently in phase 3 clinical development, and the Pfizer/BioNTech-authorised Omicron-adapted bivalent COVID-19 vaccine, both of which are based on BioNTech’s proprietary mRNA platform technology.

The US-based study, sponsored by BioNTech, is designed to evaluate the safety, effectiveness and optimal dose level of the combination vaccine, and aims to enrol 180 healthy volunteers aged 18 to 64 years.

Using a combined vaccine approach has the potential to alleviate the impact of both viruses while offering a combined administration, potentially simplifying immunisation practices for healthcare providers as well as patients and leading to higher vaccine uptake.