Moderna eyes 2025 approval for COVID, flu combination jab

Moderna’s combined mRNA-based vaccine for COVID-19 and seasonal influenza has been shown to be at least as effective as jabs given separately in a phase 1/2 trial, setting up pivotal trials and a possible approval in 2025.

The mRNA-1083 generated an equivalent or better immunological response compared to current flu vaccines, matching GSK’s Fluarix Quadrivalent in adults aged 50 to 64 and outperforming Sanofi’s high-dose Fluzone HD in people aged 65 to 79. In both age groups, it was also found to be as effective as Moderna’s Spikevax COVID-19 booster, with a similar side-effect profile.

Moderna’s chief executive, Stéphane Bancel, said that the combination jab will be advanced into phase 3 testing in adults aged 50 and over later this year, adding that the company “looks forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”

The hope is that combining protection against multiple respiratory pathogens could produce savings to healthcare systems, with fewer vaccines needed and reduced administration, refrigeration, and transport costs.

“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems, and economies,” said Bancel.

“Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems.”

Moderna is looking to combination vaccines as one way to compensate for the fall in sales of COVID-19 vaccines that have followed the end of the pandemic, as governments stop paying for mass immunisation programmes and the market transitions to a conventional commercial model.

Sales of its COVID-19 vaccines were $19.2 billion in 2022, but are expected to fall to between $6 billion and $8 billion this year.

Rival mRNA developer BioNTech and partner Pfizer are also working on a combination COVID-19/flu shot, currently in a phase 1 trial in patients aged 18 to 64, while Novavax recently reported preliminary clinical data with its protein-based combined jab.

Last month, Moderna also reported phase 3 results with a quadrivalent flu shot, called mRNA-1010, which stimulated higher immune responses against four influenza A and B strains it targets than Fluarix, paving the way for regulatory filings.

Worldwide, flu leads to 3-5 million cases of severe diseases and 290,000-650,000 respiratory deaths annually, despite dosing with around 500-600 million doses of current vaccines every year, including 150 million in the US.