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FDA Approves Vaxelis

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine

BRIDGEWATER, N.J. and KENILWORTH, N.J. – December 26, 2018 –The U.S. Food and Drug Administration has approved Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). Vaxelis was developed as part of a joint-partnership between Sanofi and Merck (NYSE: MRK), known as MSD outside the United States and Canada.

Sanofi and Merck are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply will not be available prior to 2020.

Indication for Vaxelis

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. Vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Select Safety Information for Vaxelis

Vaxelis is contraindicated in children with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of Vaxelis, any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or
H. influenzae type b vaccine.

Do not administer Vaxelis to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), within 7 days of a pertussis-containing vaccine, that is not attributable to another identifiable cause.

Do not administer Vaxelis to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Vaccination with Vaxelis may not protect all individuals.

Carefully consider benefits and risks before administering Vaxelis to persons with a history of:

fever of ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine.
seizures within 3 days after a previous pertussis-containing vaccine.

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Vaxelis.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including Vaxelis, to an infant born prematurely should be based on considerations of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

Urine antigen detection may not have definitive diagnostic value in suspected H. influenza type b disease following vaccination with Vaxelis.

The solicited adverse reactions following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).

Please see the full Prescribing Information for Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine).

Dosage and Administration for Vaxelis

The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.

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.

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