Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, has announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) has voted to update the pneumococcal vaccination guidelines for adults. The committee recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for adults aged 50 and older.
The updated guidelines advise a single dose of CAPVAXIVE for:
- Adults 50 years and older who haven’t received a pneumococcal conjugate vaccine or whose vaccination history is unknown.
- Adults aged 19-49 with certain medical conditions or risk factors who haven’t received a pneumococcal conjugate vaccine.
- Adults 19 and older who began their vaccination with PCV13 (pneumococcal 13-valent conjugate vaccine) but haven’t completed the recommended PPSV23 (pneumococcal 23-valent polysaccharide vaccine) doses.
Shared decision-making is also recommended for a supplemental dose of CAPVAXIVE for adults aged 65 and older who have completed their vaccination series with both PCV13 and PPSV23.
CAPVAXIVE is indicated for:
- Active immunization against invasive disease and pneumonia caused by specific Streptococcus pneumoniae serotypes in individuals 18 years and older.
- Prevention of pneumonia from the same serotypes in individuals 18 years and older.
The vaccine should not be given to individuals with a history of severe allergic reactions to any component of CAPVAXIVE or to diphtheria toxoid. The indication for pneumonia prevention is approved under accelerated approval based on immune response data, with continued approval contingent upon further clinical verification.
Dr. Eliav Barr, Merck’s Chief Medical Officer, remarked, “The CDC’s decision to lower the vaccination age to 50 is a potential practice-changing milestone that may enhance access and improve vaccination rates. We appreciate the CDC’s commitment to combating invasive pneumococcal disease and pneumococcal pneumonia in adults.”
According to CDC data from 2018-2022, CAPVAXIVE covers serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) cases in adults 50 and older, compared to about 52% covered by PCV20 (pneumococcal 20-valent conjugate vaccine). It’s important to note that there are no studies comparing the efficacy of CAPVAXIVE and PCV20.
These provisional recommendations will be published on the CDC website and will become official after review by the CDC director and the Department of Health and Human Services.
Select Safety Information for CAPVAXIVE
- CAPVAXIVE should not be given to those with a history of severe allergic reactions to any component of the vaccine or to diphtheria toxoid.
- Individuals with altered immune systems may have a reduced immune response to the vaccine.
- Common adverse reactions include injection-site pain, fatigue, headache, and myalgia. For adults 50 and older, the most common reactions reported were injection-site pain (41.2%) and fatigue (19.7%).
About CAPVAXIVE
CAPVAXIVE is Merck’s 21-valent pneumococcal conjugate vaccine, approved for adults 18 and older to prevent invasive disease and pneumonia caused by specific serotypes of Streptococcus pneumoniae. It is administered as a single dose.
About Pneumococcal Disease
Pneumococcal disease is caused by the bacteria Streptococcus pneumoniae, which has over 100 serotypes. This disease can manifest as either invasive or non-invasive illnesses. Non-invasive forms include pneumonia, while invasive forms involve bacteremia, bacteremic pneumonia, and meningitis. Pneumococcal pneumonia is the most common presentation among adults, with over 150,000 hospitalizations each year in the U.S.
