Initial U.S. Approval: 2021
VAXNEUVANCE is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae… in individuals 6 weeks of age and older.
[S]erious adverse events up to 6 months following vaccination with the 4-dose series were reported by 9.6% of VAXNEUVANCE recipients…
Up to 30 days following completion of Doses 1 through 3, serious adverse events were reported by 4.8% of VAXNEUVANCE recipients… febrile seizure was reported in a 9 week old female… one day after receiving VAXNEUVANCE… and recommended infant vaccines.
The final vaccine is prepared by blending… with aluminum phosphate adjuvant in a final buffer containing histidine, polysorbate 20…
Each 0.5 mL dose contains… 1 mg of polysorbate 20… and 125 mcg of aluminum as aluminum phosphate adjuvant.
VAXNEUVANCE has not been evaluated for carcinogenic or mutagenic potential or for impairment of male fertility in animals.