Merck known as MSD outside the United States and Canada, announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously recommended CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for adults 65 years and older for pneumococcal vaccination.
The ACIP specifically recommends a single dose of CAPVAXIVE for:
- Adults 65 and older who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown.
- Adults 19-64 with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown.
- Adults 19 and older who started their pneumococcal vaccine series with PCV13 but have not received all recommended PPSV23 doses.
Additionally, shared clinical decision-making is recommended for a supplemental dose of CAPVAXIVE for adults 65 and older who have completed their vaccine series with both PCV13 and PPSV23.
CAPVAXIVE is indicated for active immunization to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in adults 18 and older.
Do not administer CAPVAXIVE to individuals with a severe allergic reaction to any component of the vaccine or diphtheria toxoid. Individuals with altered immunocompetence, including those on immunosuppressive therapy, may have a reduced immune response.
The most commonly reported (>10%) adverse reactions in individuals 18-49 years old receiving CAPVAXIVE were injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). For those 50 and older, the most commonly reported adverse reactions were injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
These provisional recommendations will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services.
“CAPVAXIVE represents an innovative approach to preventing invasive pneumococcal disease in adults, specifically designed to protect against the strains causing the majority of severe disease in those 65 and older,” said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories. “The ACIP vote recognizes the clinical profile of CAPVAXIVE for adults in the U.S., and we look forward to the CDC’s final, published recommendations.”
At Merck, known as MSD outside the United States and Canada, we are unified around our purpose: using leading-edge science to save and improve lives worldwide. For over 130 years, we have developed important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company globally, delivering innovative health solutions for disease prevention and treatment in people and animals. We foster a diverse, inclusive workforce and operate responsibly to ensure a safe, sustainable, and healthy future for all communities. For more information, visit Merck’s website.
