Moderna’s combination flu and COVID-19 vaccine showed promising results in a Phase 1/2 trial, the company announced Wednesday.
The vaccine, dubbed mRNA-1083, showed efficacy that was equal to or greater than both licensed quadrivalent flu vaccines that are currently available, Moderna said in a press release. The shot also achieved antibody levels similar to Moderna’s Spikevax bivalent COVID booster.
The results will buoy the candidate forward into a Phase 3 trial later this year, with the drugmaker hoping to gain approval from the Food and Drug Administration in 2025.
“With today’s positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline,” said Moderna CEO Stéphane Bancel in a statement.
He added that the combination shot offers an important opportunity to improve the experience for both consumers and providers, boost compliance with public health recommendations and deliver value for the nation’s healthcare systems.
“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies,” he continued. “We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”
In addition to the efficacy data, Moderna noted no new safety concerns were pinpointed in the Phase 1/2 trial.
The company did, however, note that rates of local and systemic adverse reactions after the shot were similar to those caused by its standalone COVID-19 vaccine, and most were grade 1 or 2 in severity. Fewer than 4% of participants aged 50 or up experienced grade 3 solicited local or systemic reactions, the company said.
The positive Phase 1/2 results for mRNA-1083 come after Moderna experienced some setbacks with its standalone flu vaccine mRNA-1010 earlier this year.
In April, Moderna announced disappointing Phase 3 trial results for mRNA-1010.
The pharma industry has experienced a dent in sales as COVID-19 vaccination rates have fallen. Still, Moderna is banking on flu and combination vaccines to help make up for some of that decrease and expects its respiratory business to reach between $8 billion and $15 billion in 2027.
Moderna is in the process of developing another combination flu and RSV vaccine, as well as a triple vaccine that targets flu, RSV and COVID-19.
This all comes against the backdrop of the fall booster push, with the Centers for Disease Control and Prevention recently recommending that everyone get an updated COVID shot this fall.
