Influenza virus vaccine (GlaxoSmithKline)

Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year

a day ago

• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA. • The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010. • Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.

Moderna Restructures Pipeline, Prioritizes Key Approvals, and Cuts R&D Spending

8 months ago

• Moderna is reducing its research and development expenses by 20%, aiming for $16 billion between 2025 and 2028, to focus on profitability. • The company is prioritizing ten product approvals by 2027, including vaccines for COVID-19, flu, and RSV, while streamlining its pipeline. • Positive Phase 3 results were announced for Moderna's RSV vaccine in high-risk adults under 60, with plans to seek expanded FDA approval. • Moderna is delaying its break-even goal to 2028 and anticipates 2025 sales between $2.5 billion and $3.5 billion amid shifting market dynamics.

Pfizer-BioNTech COVID-Flu Combo Vaccine Faces Setback Due to Influenza B Response

9 months ago

• Phase 3 trial of Pfizer-BioNTech's combined COVID-19 and influenza mRNA vaccine reveals suboptimal antibody response for influenza B component, necessitating formula adjustments. • The 8,000-subject study aimed to demonstrate non-inferiority to existing Comirnaty COVID-19 vaccine and standard flu vaccines, following promising phase 1/2 results. • Setback potentially opens opportunity for Moderna, whose competing COVID-flu combination vaccine showed superior immune responses in Phase 3 trials, targeting potential approval by 2025-2026.

Moderna's Combination Flu-COVID Vaccine Shows Superior Immune Response in Phase 3 Trial

a year ago

• Moderna's mRNA-1083 combination vaccine demonstrated significantly higher immune responses against influenza strains and SARS-CoV-2 compared to standard vaccines in adults 50 years and older. • The Phase 3 trial met all primary endpoints with particularly strong results in adults 65+ where the combination vaccine outperformed Fluzone HD for influenza and Spikevax for COVID-19 protection. • The vaccine showed an acceptable safety profile with mostly mild to moderate side effects, positioning Moderna as the first company with positive Phase 3 data for a combination respiratory vaccine.

Moderna's Combo COVID-19 and Flu Vaccine Shows Promising Results in Early Trial

2 years ago

• Moderna announced positive data from an early-stage study of its mRNA-based combination vaccine for COVID-19 and influenza, showing similar or stronger immune responses compared to standalone vaccines in older adults. • The company plans to begin Phase 3 trials of the combination vaccine later this year, with regulatory approval targeted for 2025, potentially simplifying the complicated vaccination schedule for respiratory diseases. • This development aligns with Moderna's broader respiratory franchise strategy, which expects $8-15 billion in sales by 2027 and includes successful Phase 3 results for standalone flu vaccine mRNA-1010.