Initial U.S. Approval: 2018
VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.
Non-fatal Serious Adverse Events
[W]ithin 30 days… (2.0%) who received VAXELIS… experienced a serious adverse event.
Deaths
[D]eath was reported in 6 participants (0.2%) who received VAXELIS and in 1 participant (0.1%) who received Pentacel + RECOMBIVAX HB vaccines… Causes of death among infants who received VAXELIS were asphyxia, hydrocephalus, unknown cause, sepsis and 2 cases of Sudden Infant Death Syndrome (occurring 1, 2, 10, 42, 44 and 49 days post-vaccination, respectively).
Postmarketing Experience
– Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
– Extensive swelling of injected limb (including swelling that involves adjacent joints).
– Seizure, febrile seizure, hypotonic-hyporesponsive episode (HHE).
Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants.
[P]olioviruses are individually grown in Vero cells [a continuous line of monkey kidney cells].
VAXELIS has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
What is in VAXELIS?
– Active ingredients: inactivated bacteria of diphtheria, tetanus, pertussis, Hib, and inactivated hepatitis B and polio viruses.
– Other ingredients: aluminum salts, polysorbate 80, glutaraldehyde, formaldehyde, bovine serum albumin, neomycin, streptomycin, polymyxin B, ammonium thiocyanate, yeast protein, and water.