Merck (MRK) Announces CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of VAXNEUVANCE as an Option for Pneumococcal Vaccination in Infants and Children

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) as a recommended option for vaccination in infants and children, including routine use in children under 2 years of age. Specifically, the ACIP voted to recommend that VAXNEUVANCE may be used as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children aged under 19 years according to currently recommended PCV13 dosing and schedules. Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.

These provisional recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services, and final recommendations will become official when published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid. See additional Select Safety Information for VAXNEUVANCE below.

“VAXNEUVANCE includes key serotypes that continue to cause serious disease in children under 5 years of age, specifically the 13 serotypes shared with PCV13, and the two unique serotypes, 22F and 33F. Serotypes 3, 22F and 33F are responsible for more than a quarter of all invasive pneumococcal disease cases in children. Today’s vote reinforces the importance of VAXNEUVANCE as an option to help reduce the burden of invasive disease in the pediatric population,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We applaud the ACIP and the CDC for their continued efforts to address invasive pneumococcal disease in children, and look forward to its final, published recommendations.”

Select Safety Information for VAXNEUVANCE for infants and children

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.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated with a four-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

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