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Vaxelis (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2018

Specific Treatments:

diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b

General Information

Vaxelis is a hexavalent vaccine consisting of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine). 

Vaxelis is specifically indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. Vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Vaxelis is supplied as a suspension for intramuscular injection. The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Three doses of Vaxelis constitute a primary immunization course 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.

Clinical Results

FDA Approval

The effectiveness of Vaxelis is based on the immunogenicity of the individual antigens compared to US licensed vaccines. Serological correlates of protection exist for diphtheria, tetanus, hepatitis B, poliomyelitis, and invasive disease due to H. influenzae type b. The effectiveness against pertussis is based upon the pertussis immune responses following 3 doses of Vaxelis compared to 3 doses of Pentacel, as well as the pertussis immune responses following a subsequent dose of Daptacel in the same 2 groups of children. Vaxelis , Pentacel and Daptacel contain the same pertussis antigens, manufactured by the same processes.

 

Side Effects

Adverse effects associated with the use of Vaxelis may include, but are not limited to, the following:

irritability

crying

injection site pain

somnolence

injection site erythema

decreased appetite

fever ≥38.0°C

injection site swelling

vomiting

Mechanism of Action

Vaxelis is a hexavalent vaccine consisting of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine). 

Additional Information

For additional information regarding Vaxelis or the prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b, please visit https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf

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