MV-012-968
- Generic Name
- MV-012-968
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• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the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.
RSV Treatment Landscape Expands with New Vaccines and Clinical Trials in 2024-2025
• Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market.
• The FDA has mandated new safety warnings for RSV vaccines regarding Guillain-Barré Syndrome risk, highlighting ongoing safety monitoring efforts in early 2025.
• Multiple pharmaceutical companies including Sanofi, GSK, and Pfizer are conducting advanced clinical trials in 2024, focusing on various patient populations and novel therapeutic approaches.
FDA Approves Abrysvo for RSV Prevention in Adults Aged 18-59 at Increased Risk
• The FDA has approved Abrysvo, Pfizer's RSV vaccine, for adults aged 18-59 at increased risk of RSV-associated lower respiratory tract disease.
• Abrysvo is the first RSV vaccine approved for adults younger than 50, addressing a crucial need for at-risk individuals in this age group.
• Data from the pivotal Phase 3 MONET clinical trial supported the approval, highlighting the vaccine's efficacy in preventing RSV-related illness.
• This approval marks a significant advancement in RSV prevention for younger adults with specific risk factors.
RSV Vaccine Safety Profile Monitored Across Age Groups and Populations
• Post-licensure data suggests a slightly increased risk of Guillain-Barré syndrome (GBS) following GSK and Pfizer RSV vaccination in adults 60 and older, with ongoing monitoring by the CDC and FDA.
• Clinical trials of Pfizer's RSV vaccine (Abrysvo) in pregnant individuals showed a non-statistically significant increase in preterm births, leading to its approval for use between 32 and 36 weeks of gestation.
• A Phase 3 trial indicates that the RSVpreF vaccine is safe and effective for adults aged 18-59 at high risk for severe RSV, with immunogenicity bridged to older adults from the RENOIR trial.
• Nirsevimab passive immunization for infants and young children has shown no significant safety concerns in clinical trials, although post-licensure reports indicate rare cases of serious hypersensitivity reactions.
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.
RSV Therapeutic Pipeline Shows Promise with Novel Therapies and Clinical Advancements
• Over 50 companies are actively developing more than 50 therapeutic options for Respiratory Syncytial Virus (RSV) treatment, indicating a robust pipeline.
• GSK's Arexvy vaccine demonstrated encouraging Phase III results, preventing lower respiratory tract disease (LRTD) in older adults across three RSV seasons.
• Merck's clesrovimab showed positive topline results in a Phase IIb/III trial as a preventive treatment for RSV in infants, highlighting potential for vulnerable populations.
FDA Approves Pfizer's Abrysvo RSV Vaccine for Adults 18-59 at Increased Risk
• The FDA has approved Pfizer's Abrysvo vaccine for adults aged 18-59 at increased risk of RSV-related lower respiratory tract disease (LRTD).
• Abrysvo is now the only RSV vaccine approved for this younger adult population, expanding its existing indications for older adults and pregnant women.
• The approval was based on data from the Phase 3 MONeT trial, which demonstrated the vaccine's safety, tolerability, and immunogenicity in at-risk adults.
• Common side effects in adults aged 18-59 include pain at the injection site, muscle pain, joint pain, and nausea, consistent with previous studies.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath