FDA Approves Merck's Capvaxive (V116) Vaccine to Combat Pneumococcal Disease in Adults

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Tailored for adults, V116's effectiveness covers serotypes linked to 84% of invasive pneumococcal disease in those 50+, outperforming existing vaccines in immune response rates.

Merck has achieved a significant milestone with the approval of its investigational 21-valent pneumococcal conjugate vaccine, V116, by the US Food and Drug Administration (FDA). This groundbreaking decision follows four compelling Phase 3 trials results underscoring V116’s efficacy in preventing responsible for approximately 84% of invasive pneumococcal disease in adults 50 and older.

Heather Platt, DMD, a part of Merck's global clinical development for vaccines, emphasized the significance of this achievement, "One important reason we are so invested in the pneumococcal vaccine space is that we truly understand the burden of disease in adults. The burden of this disease has prompted many vaccine manufacturers to invest in the disease. They are the keyway to preventing disease, morbidity, and mortality."

The Phase 3 trial, STRIDE-10, demonstrated V116’s superiority over the existing PPSV23 vaccine across multiple metrics. V116 elicited robust immune responses for 12 shared serotypes and significantly outperformed PPSV23 in immune response rates for nine unique serotypes not covered by the older vaccine. The safety profile of V116 was comparable to PPSV23, reinforcing its suitability for widespread use.

“PPSV23 is a vaccine that has been used for close to 40 years. There are newer conjugate vaccines that have been introduced into the vaccination guidelines. Our clinical development program evaluated V116 compared to PCV20 and also compared to PPSV23,” Platt notes. “We looked at surveillance data over time and picked the serotypes, selected these serotypes that are the ones circulating in adults, really the ones causing disease. We have serotypes that are in currently licensed vaccines, and then we have unique serotypes that are not in any currently licensed vaccine.”

Merck also presented data suggesting that V116 could reduce the health and economic burden of pneumococcal disease across multiple European countries, underscoring its potential impact in real-world settings.

“When you prevent morbidity, you're also preventing fatalities, death, you're preventing hospitalizations, loss of work, you're limiting caregiver burden. So all of those are incredibly important because that's healthcare utilization, that's strain on the healthcare system. If we can prevent the disease from happening, we have an overall positive benefit on public health.”

Merck, a leading global biopharmaceutical company, leverages the power of cutting-edge science to improve lives worldwide. With a legacy of over 130 years, Merck continues to innovate through breakthroughs in medicine and vaccines to create a healthier future.

“As it relates to pneumococcal disease, we remain invested. Invested in evaluating the right approach. Right now, V116 is taking an adult-specific approach, which will complement our pediatric vaccines. We remain invested in understanding the serotype epidemiology, the trend of what's happening with vaccination uptake and impact, and looking for ways to improve.”

The FDA's approval of Merck's 21-valent pneumococcal conjugate vaccine, V116, is a significant milestone in adult pneumococcal vaccination. Supported by Phase 3 trial data, V116 demonstrates efficacy and safety comparable to existing vaccines, offering new options against pneumococcal disease. Merck's commitment to V116 underscores its dedication to global health. As V116 prepares for widespread use, its potential to reduce disease burden and improve public health outcomes is promising.

Reference
1. MERCK. U.S. FDA Approves CFDA Approves Merck's Capvaxive (V116) Vaccine to Combat Pneumococcal Disease in Adults (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults. Published June 17, 2024. Accessed June 17, 2024. https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/
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