| Drug Name |
CAPVAXIVE™ (pneumococcal 21-valent conjugate vaccine) Injection - formerly V116 |
| Active Ingredient |
pneumococcal 21-valent conjugate vaccine |
| Date of Approval |
June 17th, 2024 |
| Manufacturer |
Merck |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication: CAPVAXIVE™ is a vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. |
| Therapeutic Class |
Vaccine, pneumococcal 21-valent conjugate |
| Formulation |
Injectable Solution, for Intramuscular Use |
| MoA |
CAPVAXIVE™ vaccine protects against invasive pneumococcal disease by inducing opsonophagocytic killing of Streptococcus pneumoniae, targeting 22 serotypes including 15B and cross-reacting with 15C due to structural similarity. |
| Dosing and Administration |
For intramuscular use.
Administer a single dose (0.5 mL). |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
Pneumococcal disease is caused by Streptococcus pneumoniae, with around 100 different serotypes affecting adults and children differently. It can manifest as non-invasive pneumonia or invasive conditions such as bacteremia, bacteremic pneumonia, and meningitis. Pneumococcal pneumonia, a common form in adults, leads to significant hospitalizations annually, exceeding 150,000 in the U.S. CAPVAXIVE™ is the first pneumococcal vaccine specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease cases. |
| Expected Market Launch Date |
Availability is anticipated late July of 2024. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
$287 |
| Product Discontinuation |
N/A |
| Clinical Trials |
CAPVAXIVE™ was evaluated for safety across four clinical studies conducted in the Americas, Europe, and Asia Pacific, involving individuals aged 18 to 97 years. A total of 4,556 participants received CAPVAXIVE™, with 2,021 receiving an active comparator vaccine. Safety assessments included solicited injection-site and systemic adverse reactions from Day 1 to Day 5 post vaccination, and unsolicited adverse events from Day 1 to Day 30. Serious adverse events (SAEs) were monitored up to 6 months post vaccination. Study 1 (NCT05425732) focused on individuals aged 18 years and older who were vaccine-naive for pneumococcal disease, comparing CAPVAXIVE™ to Prevnar 20. It showed significant immune response for serotype 15B in older adults receiving CAPVAXIVE™, with 64.7% showing a ≥4-fold rise in opsonophagocytic assay (OPA) titers. The geometric mean titer (GMT) for serotype 15B OPA following CAPVAXIVE™ administration was 4,400.6, slightly lower than that after Prevnar 20 (GMT ratio 0.95, 95% CI: 0.84-1.07). Study 2 (NCT05464420) assessed CAPVAXIVE™ versus Pneumovax 23 in adults aged 18-49 years, demonstrating higher immune responses in the younger cohort across multiple serotypes. Study 3 (NCT05420961) evaluated CAPVAXIVE™ in individuals aged 50 years and older, showing consistent immunogenicity across different prior vaccination histories. Study 4 (NCT05526716) examined concomitant versus sequential administration of CAPVAXIVE™ with quadrivalent influenza vaccine (QIV) in adults aged 50 and older, finding comparable safety profiles and immune responses for most pneumococcal serotypes, though non-inferiority was not met for serotype 23B. Overall, the incidence of serious adverse events was low and comparable between CAPVAXIVE™ and active comparator groups within both 1-month and 6-month post vaccination periods, with notable adverse reactions including acute allergic reactions and injection-site cellulitis. |
| Sources |
U.S. Food and Drug Administration. FDA Approves
CAPVAXIVE, a Pneumococcal 21-Valent Conjugate Vaccine.
Available at: https://www.fda.gov/media/179426/download?
attachment. Published June 2023. Accessed June 21, 2024.
Merck & Co., Inc. U.S. FDA Approves CAPVAXIVE,
Pneumococcal 21-Valent Conjugate Vaccine for
Prevention of Invasive Pneumococcal Disease and
Pneumococcal Pneumonia in Adults. Available at: https://www.merck.com/news/u-s-fda-approves-
capvaxive-pneumococcal-21-valent-conjugate-
vaccine-for-prevention-of-invasive-
pneumococcal-disease-and-pneumococcal
-pneumonia-in-adults/. Published June 2023.
Accessed June 21, 2024.
Drugs.com. Capvaxive Approval History.
Available at: https://www.drugs.com/history/
capvaxive.html.
Accessed June 21, 2024.
Merck & Co., Inc. Capvaxive [package insert]. Available at: https://www.merck.com/product
/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf. Published June 2023. Accessed June 21, 2024.
Sherkow J. Merck’s Pneumococcal Vaccine Receives FDA Approval. BioPharma Dive. Available at: https://www.biopharmadive.com/news/merck-pneumococcal-vaccine-fda-approval-capvaxive/719227/. Published June 2023. Accessed June 21, 2024.
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