Stay informed with our
free newsletters

Merck Receives Positive CHMP Opinion for VAXNEUVANCE

Merck  known as MSD outside the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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 CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected by the end of the year.

The CHMP opinion was based on data from seven randomized, double-blind clinical studies evaluating VAXNEUVANCE in 7,438 individuals from a variety of adult populations and clinical circumstances. 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 Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years and older.

Pharmaceutical Drug Delivery Market - Global Forecast to 2026

Pharmaceutical Drug Delivery Market - Global Forecast to 2026

by Route of Administration (Oral, Injectors, Implantable, Syrups, Gels, Pulmonary, Solutions, Tablets, Syringes), Application (Cancer, Diabetes), Facility of Use (Hospitals), COVID-19 Impact

Download free sample pages

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.

About VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
VAXNEUVANCE, Merck’s 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.

VAXNEUVANCE is indicated in the U.S. for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine.

U.S. Select Safety Information for VAXNEUVANCE in Adults 18 Years of Age and Older
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.

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. 

Source: Merck & Co.
Date: Oct 15, 2021


Share this news: