Capvaxive FDA Approval History
Last updated by Judith Stewart, BPharm on June 18, 2024.
FDA Approved: Yes (First approved June 17, 2024)
Brand name: Capvaxive
Generic name: pneumococcal 21-valent conjugate vaccine
Dosage form: Injection
Previous Name: V116
Company: Merck
Treatment for: Pneumococcal Disease Prophylaxis
Capvaxive (pneumococcal 21-valent conjugate vaccine) is a 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older.
- Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different serotypes of pneumococcal bacteria, and certain serotypes put more people at risk for invasive pneumococcal illnesses, such as bacteremia, bacteremic pneumonia, and meningitis, as well as non-invasive pneumonia.
- Capvaxive is indicated for:
- active immunization for the prevention of invasive disease 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 individuals 18 years of age and older.
- active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - Capvaxive is a single dose administered by intramuscular injection.
- Common adverse reactions in individuals 18 through 49 years of age include 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%).
Common adverse reactions in individuals 50 years of age and older include injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
Development timeline for Capvaxive
Further information
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