23-valent pneumococcal polysaccharide vaccine
- Generic Name
- 23-valent pneumococcal polysaccharide vaccine
FDA Approves Capvaxive, First Adult-Specific 21-Valent Pneumococcal Vaccine
• MSD's Capvaxive, a groundbreaking 21-valent pneumococcal vaccine, receives FDA approval as the first shot specifically designed for adults, covering 84% of invasive pneumococcal disease cases in those over 50.
• The vaccine includes eight unique serotypes not found in any other approved pneumococcal vaccine, providing broader protection than Pfizer's Prevnar 20 which covers 52% of cases in adults.
• CDC's Advisory Committee on Immunization Practices will meet on June 27th to discuss recommendations for Capvaxive, potentially expanding vaccination guidelines for adults aged 50 and older.
Merck's CAPVAXIVE Receives Positive EU CHMP Opinion for Pneumococcal Vaccine
• The European Medicines Agency's CHMP recommended CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumonia in adults 18 and older.
• CAPVAXIVE is designed to protect against Streptococcus pneumoniae serotypes responsible for the majority of invasive pneumococcal disease cases.
• The recommendation is supported by Phase 3 STRIDE trial results, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults.
• If approved, this would be the fourth authorization of CAPVAXIVE, having already been approved in the U.S., Canada, and Australia.
Sanofi and SK bioscience's 21-Valent Pneumococcal Vaccine Enters Phase III Trials
• Sanofi and SK bioscience have initiated global Phase III trials for their 21-valent pneumococcal conjugate vaccine candidate, GBP410, targeting individuals aged six weeks to 17 years.
• The Phase III program will enroll over 7,700 participants across multiple regions, assessing the vaccine's safety and immunogenicity with varying doses based on age.
• This collaboration expands on their existing partnership, with Sanofi paying SK bioscience €50M upfront and potential milestone payments for developing next-generation pneumococcal vaccines.
• GBP410 demonstrated comparable immunogenicity and safety to Prevnar 13 in Phase II trials, suggesting its potential to minimize invasive pneumococcal disease in young children.
Merck's CAPVAXIVE Shows Promise Against Pneumococcal Disease in Adults
• Merck's CAPVAXIVE, a 21-valent pneumococcal conjugate vaccine, has demonstrated robust immune responses in adults, particularly those with increased risk factors for pneumococcal disease.
• STRIDE-8 trial results indicate CAPVAXIVE's immunogenicity across all 21 serotypes, with comparable or higher immune responses compared to existing vaccines for pneumococcal disease.
• CAPVAXIVE covers serotypes responsible for approximately 84% of invasive pneumococcal disease cases in adults 50 and older, offering broader protection than PCV20.
• Modeling studies suggest CAPVAXIVE could reduce invasive pneumococcal disease incidence by 33.9% in the U.S. after 10 years, potentially preventing 14,000 more cases than PCV20.
AIM Vaccine's Serum-Free Rabies Vaccine Achieves Phase III Goals, Paving Way for Market Launch
• AIM Vaccine's iterative serum-free rabies vaccine demonstrated strong immunogenicity and safety in Phase III trials, meeting all pre-set clinical objectives.
• The vaccine is poised to become the world's first serum-free rabies vaccine, potentially reducing adverse reactions associated with animal serum residues.
• With GMP workshop process verification complete, AIM Vaccine plans to promptly submit the marketing registration application to the NMPA.
• The serum-free rabies vaccine market is projected to reach RMB22.0 billion by 2030, driven by increased safety and technological advancements.
CDC Recommends 21-Valent Pneumococcal Conjugate Vaccine (PCV21) for Adults
• The CDC recommends the 21-valent pneumococcal conjugate vaccine (PCV21) for adults, particularly those at higher risk of pneumococcal disease, to broaden protection against invasive strains.
• Clinical trials demonstrate PCV21's non-inferior immunogenicity compared to existing vaccines like PCV15, PCV20, and PPSV23, with statistically significant improvements against unique serotypes.
• Safety data from trials indicate that PCV21 has a similar safety profile to comparator vaccines, with mostly mild to moderate adverse events like injection site pain and fatigue.
• Economic models suggest PCV21's cost-effectiveness varies, potentially being cost-saving compared to PCV20 in high-risk groups, but less favorable for universal vaccination in younger adults.
FDA Approves Merck's CAPVAXIVE: First 21-Serotype Pneumococcal Vaccine Designed Specifically for Adults
• The FDA has approved Merck's CAPVAXIVE, a novel 21-valent pneumococcal conjugate vaccine specifically designed to protect adults against serotypes causing the majority of invasive pneumococcal disease.
• CAPVAXIVE includes eight unique serotypes not covered by other approved pneumococcal vaccines, targeting approximately 84% of invasive pneumococcal disease cases in adults over 50, compared to 52% covered by PCV20.
• The single-dose vaccine demonstrated robust immunogenicity across various adult populations, with the CDC's Advisory Committee on Immunization Practices expected to make recommendations for its use later this month.
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