European Commission Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Individuals 18 Years of Age and Older

KENILWORTH, NJ, USA I December 15, 2021 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today the European Commission (EC) has approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The approval allows marketing of VAXNEUVANCE in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. The use of VAXNEUVANCE in the EU should be in accordance with official recommendations.

The EC’s decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products on Human Use (CHMP), which reviewed data from seven randomized, double-blind clinical studies evaluating VAXNEUVANCE in 7,438 individuals from a variety of adult populations and clinical circumstances. These included healthy adults ages 50 years and older, adults ages 18 to 49 with risk factors for pneumococcal disease, and immunocompromised adults living with HIV. In the pivotal, double blind, active-comparator controlled study in 1,205 immunocompetent pneumococcal vaccine-naïve adults ages 50 and older, immune responses elicited by VAXNEUVANCE were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes, as assessed by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days post-vaccination. Additionally, immune responses for VAXNEUVANCE were superior to PCV13 for shared serotype 3 and for the two serotypes unique to VAXNEUVANCE, 22F and 33F. Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.

“At Merck, we are committed to helping protect more people from invasive pneumococcal disease (IPD), as well as from pneumococcal pneumonia, the most common form of pneumococcal disease in adults,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “With VAXNEUVANCE, we developed a conjugate vaccine that elicits a strong immune response to pneumococcal serotypes that contribute substantially to the burden of disease, including serotype 3, a leading cause of IPD in the EU. This approval provides physicians and patients in the European Union with a new option that can help protect against pneumococcal serotypes responsible for around 40 percent of IPD cases in adults over 65 in the largest EU member countries.”

In July 2021, VAXNEUVANCE received approval from the U.S. Food and Drug Administration (FDA) for active immunization for the prevention of invasive disease caused by sand 33F in adults 18 years and older.

Select Safety Information for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) in Adults 18 Years of Age and Older in the U.S.

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

About Pneumococcal Disease

The global prevalence of pneumococcal disease, an infection caused by bacteria called Streptococcus pneumoniae, is evolving. Highly aggressive strains, or serotypes, threaten to put more people at risk for invasive pneumococcal illnesses such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs). While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults such as those 65 years of age and older, people with HIV, and those with certain chronic health conditions.

Merck’s Commitment to Infectious Diseases

For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

SOURCE: Merck

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