CDC ACIP Endorses Merck’s CAPVAXIVE™ for Adult Pneumococcal Vaccination

Merck, operating under the name MSD outside the United States and Canada, has announced a significant development for pneumococcal vaccination among adults. The U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the use of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for specific adult populations.

CAPVAXIVE is now recommended for adults 65 and older who have not previously received a pneumococcal conjugate vaccine or whose vaccination history is unknown. Additionally, adults aged 19 to 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, should also receive a single dose. Furthermore, adults 19 and older who began their pneumococcal vaccine series with PCV13 but haven't received all recommended doses of PPSV23 are included in this recommendation.

In addition, the ACIP suggests that shared clinical decision-making be used for a supplemental dose of CAPVAXIVE in adults 65 and older who have completed their vaccination series with both PCV13 and PPSV23.

The vaccine is designed for active immunization to prevent invasive disease and pneumonia caused by specific Streptococcus pneumoniae serotypes in adults aged 18 and older. The serotypes covered by CAPVAXIVE include 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

It is important to note that CAPVAXIVE should not be administered to individuals with a history of severe allergic reactions to any component of the vaccine or to diphtheria toxoid. Additionally, individuals with altered immunocompetence, including those on immunosuppressive therapy, may experience a reduced immune response to the vaccine.

According to Merck, the accelerated approval for CAPVAXIVE in preventing pneumonia is based on immune responses measured by opsonophagocytic activity (OPA). Continued approval may depend on the verification and description of clinical benefits in a confirmatory trial. The CDC and the Department of Health and Human Services are set to review and finalize these provisional recommendations.

Dr. Eliav Barr, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, highlighted that CAPVAXIVE represents an innovative approach to preventing invasive pneumococcal disease in adults. He emphasized that the ACIP’s unanimous vote signifies the clinical value of CAPVAXIVE and expressed anticipation for the CDC’s final recommendations.

The safety profile of CAPVAXIVE indicates that the most common adverse reactions reported among individuals aged 18 through 49 years who received the vaccine included injection-site pain, fatigue, headache, myalgia, injection-site erythema, and injection-site swelling. For those aged 50 and older, the most common adverse reactions were injection-site pain, fatigue, and headache. However, it is worth noting that vaccination may not protect all recipients.

Merck has a long-standing history of developing important medicines and vaccines, aiming to advance the prevention and treatment of diseases globally. The company’s commitment to innovative health solutions continues to place it at the forefront of research and development in the biopharmaceutical industry.