Biotech
Monday, June 10th, 2024 2:10 pm EDT
Key Points
- Moderna’s Combination Vaccine Success: Moderna announced that its combination vaccine targeting both Covid-19 and the flu proved more effective than existing standalone shots in a late-stage trial. The vaccine, mRNA-1083, demonstrated significantly higher immune responses and acceptable safety and tolerability in 8,000 patients.
- Regulatory and Market Plans: Moderna plans to file for regulatory approval in the U.S. this summer, with hopes of market entry by 2025. The company aims to simplify protection against respiratory viruses and reduce the burden on the U.S. healthcare system.
- Competition and Development: Moderna is the first to release positive phase three data for a Covid and flu combination shot, potentially leading over Pfizer and Novavax. Both rivals are also developing combination vaccines, with Pfizer and BioNTech conducting late-stage trials and Novavax using protein-based technology.
Moderna announced that its combination vaccine targeting both Covid-19 and the flu proved more effective than existing standalone shots in a late-stage trial. This marks the first instance of positive phase three data for a Covid and flu combination shot, potentially giving Moderna an edge over rivals Pfizer and Novavax. Moderna plans to seek regulatory approval in the U.S. this summer, with hopes of market entry by 2025. The combination shot, mRNA-1083, merges Moderna’s seasonal influenza vaccine candidate and a new version of its Covid shot. In the ongoing late-stage trial involving 8,000 participants, the combination vaccine demonstrated significantly higher immune responses against three influenza strains and the Covid omicron variant XBB.1.5 compared to existing vaccines.
The study divided participants into two age groups: those 65 and above, and those between 50 and 64. In the older group, Moderna’s combination shot was compared with an enhanced flu vaccine, Fluzone HD, and Moderna’s licensed Covid shot, Spikevax. In the younger group, it was compared with the standard flu shot, Fluarix, and Spikevax. In both groups, the combination vaccine produced superior immune responses. Safety and tolerability of the combination shot were deemed acceptable, with common side effects including injection site pain, fatigue, muscle pain, and headache, mostly mild to moderate in severity.
The development of combination shots aims to simplify protection against respiratory viruses that surge simultaneously, addressing the declining vaccination rates for Covid. Stephane Bancel, Moderna’s CEO, highlighted that combination shots could also alleviate the burden on pharmacists and the U.S. health-care system, which faces labor shortages. Besides the Covid and flu combination shot, Moderna is working on vaccines combining flu and RSV, as well as a triple vaccine for Covid, flu, and RSV.
In parallel, Pfizer and BioNTech are conducting a late-stage trial for a Covid and flu combination vaccine, while Novavax is developing a similar vaccine using protein-based technology. These combination vaccines could represent a significant advancement in managing respiratory virus outbreaks, offering enhanced convenience and protection, particularly crucial during periods when these viruses are most prevalent.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/06/10/moderna-combination-covid-flu-vaccine-shows-positive-late-stage-data.html
