Vaxelis Generic Name & Formulations
Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Protect from light. Do not use after expiration date shown on the label.
Mechanism of Action
Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C. tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A tetanus antitoxoid level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of Vaxelis is considered protective.
Pertussis (whooping cough) is a respiratory disease caused by B. pertussis. This Gram-negative coccobacillus produces a variety of biologically active omponents, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.
Polioviruses, of which there are 3 serotypes (Types 1, 2, and 3), are enteroviruses. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis.
Hepatitis B virus is one of several hepatitis viruses that cause systemic infection, with major pathology in the liver. Antibody concentrations of ≥10 mIU/mL against HBsAg correlate with protection against hepatitis B virus infection.
H. influenzae type b can cause invasive disease such as meningitis and sepsis. Anti-PRP antibody has been shown to correlate with protection against invasive disease due to H. influenzae type b. Data from an efficacy study with H. influenzae type b polysaccharide vaccine in Finland indicate that an anti-PRP level of ≥1.0 mcg/mL 3 weeks after vaccination predicts protection through a subsequent 1-year period. These levels have been used to evaluate the effectiveness of H. influenzae type b conjugate vaccines, including the PRP-OMPC component of Vaxelis.
Vaxelis Dosage and Administration
Each dose is 0.5 mL IM. For infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of administration.
Give as a 3 dose series at 2 months, 4 months, and 6 months of age. May give 1st dose as early as 6 weeks of age.
3 doses of Vaxelis constitutes primary immunization against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis. Vaxelis may be used to complete the hepatitis B immunization series.
A 3-dose series of Vaxelis does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.
Pertussis Vaccination following Vaxelis
After receiving a 3-dose series of Vaxelis, complete the primary and pertussis vaccination series with Pentacel, Quadracel, or Daptacel.
Administration of Vaxelis following previous doses of other DTaP-containing Vaccines
May use Vaxelis to complete the first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or Daptacel
Administration of Vaxelis following previous doses of any Hepatitis B Vaccine
May administer a 3-dose series of Vaxelis to infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at 1 month of age.
May use Vaxelis to complete the hepatitis B vaccination series after 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in Vaxelis.
Administration of Vaxelis following previous doses of Inactivated Polio Vaccine (IPV)
May administer Vaxelis to infants and children who have received 1 or 2 doses of H. influenzae type b Conjugate Vaccine and are also scheduled to receive the other antigens in Vaxelis.
Do not administer Vaxelis if a history of severe allergic reaction (eg, anaphylaxis) associated with a previous dose of Vaxelis or any other diphtheria toxoid, tetanus toxoi-, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.
Do not administer Vaxelis if a history of encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.
Progressive Neurologic Disorder
Do not administer Vaxelis if a history of progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy) until a treatment regimen has been established and the condition has stabilized.
Vaxelis Boxed Warnings
Management of Acute Allergic Reactions
Have epinephrine (1:1000) and other appropriate agents immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.
Review the patient’s immunization history for hypersensitivity prior to administration.
Adverse Reactions following Prior Pertussis Vaccination
Carefully consider the potential benefits and possible risks of administering Vaxelis if any of the following events occur after administration of a pertussis vaccine:
Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.
Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
Persistent, inconsolable crying lasting at least 3 hours within 48 hours.
Seizures with or without fever within 3 days.
Guillain-Barré Syndrome and Brachial Neuritis
Increased risk for Guillain-Barré Syndrome (GBS) after administering Vaxelis if GBS occurred within 6 weeks of a previous vaccine containing tetanus toxoid.
May get suboptimal immune response when Vaxelis is administered to immunocompromised persons, including persons receiving immunosuppressive therapy.
Apnea in Premature Infants
Risk of apnea has been observed in some infants born prematurely.
Consider the individual infant’s medical status and the potential benefits and risks of vaccination when deciding to administer Vaxelis to infants born prematurely.
Limitations of Vaccine Effectiveness
May not protect all individuals.
Interference with Laboratory Tests
May interfere with urine antigen detection in suspected H. influenzae type b disease after vaccination with Vaxelis.
Not approved for use in individuals 5 years of age and older.
Nursing Mother Considerations
Not approved for use in individuals 5 years of age and older.
- Safety and efficacy of Vaelis in infants less than 6 weeks of age and adolescents 5 through 17 years of age have not been established.
Vaxelis Adverse Reactions
Vaxelis Clinical Trials
Effectiveness of Vaxelis
The effectiveness of Vaxelis is based on the immunogenicity of the individual antigens compared to US licensed vaccines.
Immunogenicity – US Study 005
Infants were randomly assigned to receive 3 doses of Vaxelis at 2, 4, and 6 months of age and Daptacel and PedvaxHIB at 15 months of age, or Control group vaccines (3 doses of Pentacel vaccine at 2, 4, and 6 months of age + Recombivax HB at 2 and 6 months of age and Daptacel and ActHIB at 15 months of age). All subjects received concomitant vaccines: RotaTeq at 2, 4 and 6 months and Prevnar 13 at 2, 4, 6, and 15 months of age.
Vaxelis was non-inferior to Pentacel + Recombivax HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective levels of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and PRP antigens, and pertussis vaccine response rates and GMCs (except FHA), following 3 doses of the vaccine.
To complete the 4-dose pertussis primary vaccination series, participants in both groups received Daptacel at 15 months of age and were evaluated for immune responses to pertussis antigens one month later. The non-inferiority criteria for vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose.
Concomitantly Administered Vaccines – US Study 006
In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received Vaxelis relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [Vaxelis group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67).
Vaxelis Patient Counseling
Inform the parent or guardian of the following:
The potential benefits and risks of immunization with Vaxelis.
The common adverse reactions that have occurred following administration of Vaxelis or other vaccines containing similar ingredients.
Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.