Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate

Merck & Co., a global leader in pharmaceutical development, has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of its innovative pneumococcal conjugate vaccine candidate, V114. The 15-valent vaccine is designed to help protect adults aged 18 and older from pneumococcal disease, which can lead to serious infections such as pneumonia, meningitis, and blood infections.

The vaccine’s approval could have a significant impact on public health, particularly for adults at higher risk of pneumococcal disease. Merck’s applications, currently under review by the FDA and EMA, are based on extensive data from Phase 2 and Phase 3 clinical trials, which involved diverse adult populations. These trials included healthy adults, as well as individuals at higher risk, such as those with chronic medical conditions, older adults aged 65 and above, and individuals living with HIV.

What Is the V114 Pneumococcal Conjugate Vaccine?

The V114 pneumococcal conjugate vaccine candidate is a 15-valent vaccine, meaning it targets pneumococcal polysaccharides from 15 different serotypes. These serotypes are responsible for a large proportion of invasive pneumococcal diseases globally, including the 22F and 33F strains, which are notably prevalent among older adults. Unlike existing pneumococcal vaccines, which do not contain these serotypes, V114 offers broader coverage by targeting these additional strains.

V114 contains pneumococcal polysaccharides from 15 serotypes, all conjugated to the CRM197 carrier protein. This advanced formulation is designed to boost the immune response, offering protection against a wide range of pneumococcal infections. The inclusion of serotypes 22F and 33F represents a significant step forward, as these are known to be associated with serious disease in older adults.

V114’s Role in Public Health

Pneumococcal disease remains a major cause of morbidity and mortality worldwide, particularly in vulnerable populations. For over a century, Merck has been at the forefront of developing vaccines that address significant public health challenges, and V114 is a continuation of this legacy. The company’s long-standing expertise in vaccine development is reflected in its comprehensive portfolio of pneumococcal vaccines, which have already made a measurable difference in preventing disease globally.

Dr. Roy Baynes, Merck Research Laboratories’ Senior Vice President and Head of Global Clinical Development, and Chief Medical Officer, highlighted the importance of the V114 submission, stating: “For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio. These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”

The Regulatory Process: What’s Next for V114?

The FDA and EMA’s reviews of Merck’s applications for V114 are based on promising Phase 2 and Phase 3 clinical study results. These trials evaluated the vaccine’s safety, efficacy, and immune response across various adult groups, including those with underlying health conditions who are at higher risk of pneumococcal disease. Given the extensive clinical data Merck has presented, the vaccine candidate is expected to meet the rigorous standards set by both regulatory bodies.

Moreover, Merck’s V114 pneumococcal vaccine candidate had already earned the FDA’s Breakthrough Therapy Designation for the prevention of invasive pneumococcal disease in both pediatric patients (six weeks to 18 years) and adults (18 years and older). This designation underscores the potential of V114 to address unmet medical needs and offer an advanced treatment option for those most vulnerable to pneumococcal disease.

V114’s Potential Impact on Global Pneumococcal Disease Prevention

If approved by the FDA and EMA, V114 could significantly expand the available options for pneumococcal disease prevention in adults, particularly among those at high risk. The inclusion of additional serotypes, including 22F and 33F, addresses a critical gap in existing pneumococcal vaccines and may help reduce the burden of disease in aging populations worldwide.

Merck’s submission for V114 represents a major milestone in the ongoing fight against pneumococcal disease. As global health authorities continue to evaluate the data, the pharmaceutical giant’s innovation could play a pivotal role in preventing invasive pneumococcal disease and improving health outcomes for adults globally.