Pneumococcal 21-valent Conjugate Vaccine (Merck Sharp & Dohme)
- Generic Name
- Pneumococcal 21-valent Conjugate Vaccine (Merck Sharp & Dohme)
Merck's WINREVAIR Shows Promising Phase 3 Results for Pulmonary Arterial Hypertension Treatment
• Merck's Phase 3 ZENITH trial for WINREVAIR demonstrated promising results for treating pulmonary arterial hypertension, adding to the company's growing therapeutic portfolio.
• Despite positive clinical developments including WINREVAIR's success and European Commission approval of CAPVAXIVE®, Merck's stock has declined 3.3% over the past month amid broader market uncertainty.
• The company continues to strengthen its position in oncology with KEYTRUDA while expanding into cardiometabolic disease areas, though recent performance has underperformed both the US market and pharmaceutical industry benchmarks.
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.
Vaxcyte's 31-Strain Pneumococcal Vaccine Shows Superior Immune Response Over Prevnar 20 in Phase 1/2 Trial
Vaxcyte's VAX-31 pneumococcal vaccine demonstrated stronger immune responses against 18 out of 20 serotypes compared to Pfizer's Prevnar 20 in Phase 1/2 trials. The promising results have prompted the company to advance to Phase 3 trials in 2025, potentially challenging Pfizer's dominance in the $10+ billion pneumococcal vaccine market.
Evorpacept Shows Promise in HER2-Positive Gastric Cancer: Updated ASPEN-06 Data
• ALX Oncology's ASPEN-06 Phase 2 trial evaluates evorpacept, a CD47-blocker, in HER2-positive advanced gastric cancer patients who have been previously treated.
• Updated data from the ASPEN-06 trial were presented at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI).
• The virtual event hosted by ALX Oncology on January 23, reviewed the ASPEN-06 data, focusing on evorpacept's potential in immuno-oncology.
• The ASPEN-06 trial is a phase 2/3 study of evorpacept in patients with HER2-overexpressing gastric/gastroesophageal cancer.
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.
FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions
• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity.
• Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors.
• Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors.
• Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.
Subcutaneous Keytruda Meets Primary Endpoint in Phase III NSCLC Trial
• Merck's subcutaneous formulation of Keytruda, combined with Alteogen's berahyaluronidase alfa, demonstrates comparable efficacy to intravenous Keytruda in treating first-line metastatic non-small cell lung cancer (NSCLC).
• The Phase III MK-3475A-D77 trial met its primary endpoint, indicating that subcutaneous Keytruda, administered every six weeks, performs as effectively as the intravenous infusion.
• The subcutaneous version offers potential benefits, including easier administration and expanded access in regions with limited infusion center availability, which could extend Keytruda's market presence.
• Analysts suggest FDA may approve the subcutaneous formulation across all indications currently approved for intravenous Keytruda, similar to Roche's Tecentriq.
Pharma Update: Regulatory Approvals, Clinical Data, and Strategic Moves
• The FDA has approved Pfizer's Abrysvo for RSV in adults under 60 at increased risk, making it the only RSV vaccine for this age group.
• Novo Nordisk's oral semaglutide (Rybelsus) demonstrated a 14% reduction in major adverse cardiovascular events in type 2 diabetes patients.
• Sanofi is in talks to sell a controlling stake in its consumer healthcare business, Opella, valuing it at approximately 16 billion euros.
• The EMA's CHMP recommended approval of AstraZeneca's Wainzua for hereditary transthyretin-mediated amyloidosis (ATTRv-PN).
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.
Merck Highlights Infectious Disease Advances at IDWeek 2024
• Merck will present Phase 2b/3 trial results for clesrovimab, a preventative monoclonal antibody against respiratory syncytial virus (RSV) in infants.
• Data from the Phase 3 STRIDE-8 trial of CAPVAXIVE, a pneumococcal 21-valent conjugate vaccine, in adults at increased risk of pneumococcal disease will be shared.
• Week 48 data from a Phase 2 study of a once-weekly oral combination of islatravir and lenacapavir for HIV-1 treatment will be presented.
• Merck's presentations at IDWeek 2024 underscore its commitment to addressing global health needs through innovative vaccines and infectious disease therapies.
FDA Updates: Approvals for RSV Vaccine, Pneumococcal Vaccine, and TB Drug Alongside Device Recalls
• The FDA granted traditional approval to Sirturo (bedaquiline) for treating rifampin- and isoniazid-resistant tuberculosis in adults and children, based on Phase 3 STREAM study data.
• mResvia, an mRNA-based vaccine, received FDA approval for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.
• Capvaxive, a pneumococcal 21-valent conjugate vaccine, was approved for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older.
• Several critical care medical devices, including infusion pumps and chest compression devices, were recalled due to potential for serious adverse health consequences.
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.
Drug Development Updates
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