Biotech
Tuesday, June 18th, 2024 3:54 pm EDT
Key Points
- FDA approved Merck’s new pneumococcal vaccine, Capvaxive, designed for adults to protect against 21 strains of pneumococcus, preventing severe forms of pneumococcal disease including pneumonia.
- Capvaxive addresses a critical need for adults at risk, particularly older individuals and those with chronic health conditions prone to invasive pneumococcal disease, which can lead to meningitis and bacteremia.
- Merck anticipates Capvaxive to be a significant growth driver, potentially capturing majority market share among adult pneumococcal vaccines, distinguishing itself from Pfizer’s Prevnar 20 by targeting additional strains and demonstrating robust efficacy in clinical trials like STRIDE-3.
Merck has achieved a significant milestone with the FDA approval of Capvaxive, a novel pneumococcal conjugate vaccine designed specifically for adults. This vaccine targets 21 strains of pneumococcus bacteria, offering broader protection than existing shots and aiming to prevent severe forms of pneumococcal disease, including pneumonia. The approval marks the first of its kind tailored for adults, addressing a critical need, particularly for older adults and those with chronic health conditions who are at higher risk of invasive pneumococcal disease. This condition can lead to serious complications such as meningitis and bacteremia, contributing to hospitalizations and mortality among the elderly population.
Heather Platt from Merck highlighted the real-world impact of pneumococcal disease, emphasizing its toll on quality of life and healthcare resources, especially for individuals with chronic lung diseases. Annually, approximately 150,000 adults in the U.S. are hospitalized due to pneumococcal pneumonia, with fatalities disproportionately affecting those aged 50 and above. Despite FDA approval, Capvaxive’s availability hinges on recommendations from the CDC’s advisory panel meeting scheduled for late June, shaping eligibility criteria for its use.
Strategically, Capvaxive represents a pivotal growth opportunity for Merck amidst anticipated revenue declines from Keytruda. Analysts foresee the global market for pneumococcal vaccines, currently valued at $7 billion, expanding significantly to over $10 billion in the coming years. Merck anticipates gaining substantial market share with Capvaxive, positioning it against Pfizer’s Prevnar 20, the current leader in the adult pneumococcal vaccine market. Notably, Capvaxive covers eight strains not addressed by other vaccines, which collectively account for 30% of invasive pneumococcal disease cases in older adults, reinforcing its competitive advantage.
The FDA’s approval decision was bolstered by data from Merck’s rigorous STRIDE-3 trial, demonstrating Capvaxive’s efficacy in comparison to Prevnar 20 among adults who had not previously received a pneumococcal vaccine. Merck’s readiness to supply the vaccine by late summer underscores its commitment to addressing unmet medical needs and advancing public health outcomes. As Merck prepares to launch Capvaxive, the company is poised to reshape the landscape of adult pneumococcal vaccination, expecting rapid uptake supported by compelling clinical evidence that resonates with healthcare providers and policymakers alike.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/06/17/fda-approves-merck-pneumococcal-disease-vaccine-designed-for-adults.html
