Vaxneuvance FDA Approval History
Last updated by Judith Stewart, BPharm on June 23, 2022.
FDA Approved: Yes (First approved July 16, 2021)
Brand name: Vaxneuvance
Generic name: pneumococcal 15-valent conjugate vaccine
Dosage form: Injection
Treatment for: Pneumococcal Disease Prophylaxis
Vaxneuvance (pneumococcal 15-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.
- Vaxneuvance contains capsular polysaccharide conjugates for the 13 serotypes contained in the currently available 13-valent pneumococcal conjugate vaccine (PCV13) with two additional serotypes, 22F annd 33F which are associated with a high degree of invasiveness and antibiotic resistance.
- Vaxneuvance is administered as an intramuscular injection:
- Children- 4-dose series at 2, 4, 6 and 12 through 15 months of age.
- Adults- single dose 18 years of age and older.
- Common adverse reactions:
- in children less than 2 years of age include irritability, somnolence, injection-site pain, fever, decreased appetite, injection-site induration, injection-site erythema, and injection-site swelling;
- in children and adolescents 2 through 17 years of age include myalgia, injection-site swelling, injection-site erythema, fatigue, headache, and injection-site induration;
- in adults 18 through 49 years of age include injection-site pain, fatigue, myalgia, headache, injection-site swelling, injection-site erythema, and arthralgia;
- in adults 50 years of age and older include injection-site pain, myalgia, fatigue, headache, injection-site swelling, injection-site erythema, and arthralgia.
Development timeline for Vaxneuvance
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