influenza vaccine
- Generic Name
- influenza vaccine
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the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.
Sanofi Accelerates Flu Vaccine Production for 2025-26 Season Amid Severe Current Outbreak
• Sanofi has begun manufacturing influenza vaccines for the 2025-26 season, adopting strains recently selected by the FDA that match those already in production.
• The US is experiencing one of its worst flu seasons in decades with 40 million illnesses, 520,000 hospitalizations, and 22,000 deaths reported through early March 2025.
• Sanofi plans to ship its vaccine portfolio, including FLUZONE High-Dose, FLUBLOK, and FLUZONE, to healthcare facilities this summer to ensure timely administration at the onset of the next flu season.
Real-World Study Confirms High Effectiveness of RSV Vaccines in Older Adults
• A real-world study among older US veterans showed RSV vaccines are highly effective against infection, ED/UC visits, and hospitalization.
• The study found vaccine effectiveness of 78% against RSV infection, 79% against ED/UC visits, and 80% against hospital admissions.
• Vaccine effectiveness against RSV infection was 72.3% in veterans aged 80 years and older and 71.6% in those with weakened immune systems.
• The findings support current recommendations for RSV vaccination in adults aged 60 years and older, with updated CDC guidance for the 2024-2025 season.
Sanofi's Combination Flu and COVID-19 Vaccines Receive FDA Fast Track Designation
• The FDA has granted Fast Track designation to Sanofi's two combination vaccine candidates for influenza and COVID-19 in adults aged 50 and older.
• The vaccine candidates combine already licensed vaccines, Fluzone High-Dose or Flublok with Novavax's COVID-19 vaccine, aiming for simplified immunization schedules.
• Phase 1/2 trials (NCT06695117 and NCT06695130) are underway to assess the safety and immune response of the combination vaccines.
• The Fast Track designation recognizes the potential of these vaccines to reduce the burden of both influenza and COVID-19, especially in older adults.
Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines
• Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety.
• The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older.
• Novavax is collaborating with the FDA to explore potential accelerated approval pathways for both vaccine candidates, aiming for clarity by Q2 2025.
• The Phase 3 trial includes approximately 2,000 participants and builds upon positive Phase 2 data, with initial results expected by mid-2025.
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