Pediatric Hexavalent Combination Vaccine Approved by FDA

The US Food and Drug Administration has approved a hexavalent combination vaccine (Vaxelis) that is indicated for immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children younger than 5 years old.

The vaccine is approved as a 3-dose series, which consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.

Contraindicated in children with a history of anaphylaxis to any ingredient in the vaccine, health care officials are also advised not to administer Vaxelis to anyone with a history of encephalopathy, within 7 days of a pertussis-containing vaccine, that is not attributable to another identifiable cause. The vaccine is also not to be administered to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

A statement from Sanofi advised health care officials to "carefully consider benefits and risks before administering Vaxelis to persons with a history of:

• fever of 105°F or higher,
• hypotonic-hyporesponsive episode or persistent, inconsolable crying lasting 3 or more hours within 48 hours after a previous pertussis-containing vaccine,
• seizures within 3 days after a previous pertussis-containing vaccine.”

The 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%). This vaccine does not constitute a primary immunization series against pertussis.

Sanofi and Merck, who developed the vaccine as part of a joint partnership, are working to maximize production of the vaccine to allow for a sustainable supply to meet anticipated demand, but commercial supply is not expected until 2020.

An earlier version of this article was published as, "FDA OKs Pediatric Hexavalent Combination Vaccine," on PharmacyTimes.com.