Vaxneuvance

Active immunization for prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F & 33F in infants, childn & adolescents from 6 wk to 17 yr. Active immunization for prevention of invasive disease & pneumonia caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F & 33F in adults ≥18 yr.

IM Adult 0.5 mL single dose. Routine vaccination schedule Toddler & infant Recommended: 4-dose regimen (3-dose primary series followed by toddler dose): Administer 1st dose as early as 6-12 wk of age w/ 4- to 8-wk interval. Administer 4th dose at approx 11-15 mth of age & at least 2 mth after 3rd dose. Alternative: 3-dose regimen (2-dose primary series followed by toddler dose): Administer 1st dose as early as 6 wk of age & administer 2nd dose after 8 wk. Administer 3rd dose at approx 11-15 mth of age. Preterm infant <37 wk gestation at birth 4-dose regimen (3-dose primary series followed by toddler dose): Administer 1st dose as early as 6-12 wk of age w/ 4- to 8-wk interval. Administer 4th dose at approx 11-15 mth of age & at least 2 mth after 3rd dose. Catch-up vaccination schedule Adolescent & childn 2-17 yr 0.5 mL single dose. Childn 12-23 mth 2 doses w/ 2-mth interval. Infant 7-11 mth 3 doses; administer 1st 2 doses at least 4 wk apart. Administer 3rd dose after 12 mth of age, separated from the 2nd dose by at least 2 mth. Patient previously administered w/ another pneumococcal conjugate vaccine Administer Vaxneuvance after at least 2 mth.

History of severe hypersensitivity to pneumococcal 15-valent conjugate vaccine or any diphtheria toxoid-containing vaccine.

Appropriate medical treatment & supervision must be available in case of rare anaphylactic event following vaccination. Do not inj intravascularly. Possible reduced immune response to Vaxneuvance in individuals w/ altered immunocompetence including those receiving immunosuppressive therapy. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Possible bleeding or bruising in individuals receiving anticoagulants or those w/ thrombocytopenia or any coagulation disorder (eg, hemophilia). Possible reduced Ab response to active immunization in individuals w/ impaired immune responsiveness due to immunosuppressive therapy, genetic defect, HIV or other causes. May not protect all vaccine recipients. May not prevent disease caused by Strep pneumoniae serotypes that are not contained in Vaxneuvance. Not to be diluted or mixed w/ other vaccines. Not to be used if particulate matter or discoloration is found. For single use only; not to be used for >1 individual. May temporarily affect ability to drive or use machines. Pregnancy & lactation. Childn <6 wk. Potential risk of apnea in premature infants.

Pain, erythema, swelling, induration; decreased appetite, irritability, somnolence, urticaria, elevated body temp. Adult, adolescent & childn 2-17 yr: Fatigue, headache, myalgia. Adult: Arthralgia.

Concomitant administration w/ other vaccines in adults, adolescents & childn 2-17 yr. May reduce immune responses to vaccines when used concomitantly w/ immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids, therapeutic proteins & targeted immunomodulators.

Vaccines, Antisera & Immunologicals

J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.

POM