Pediatric Hexavalent Combination Vaccine Granted FDA Approval

Published Online: Monday, December 31st, 2018
Officials with the US FDA have approved a vaccine for use in children younger than age 5 that is indicated for immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Vaxelis™).

Developed as part of a joint partnership between Sanofi and Merck, the companies 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. The vaccine is approved for use as a 3-dose series, which consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. This vaccine does not constitute a primary immunization series against pertussis. 

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 press release from Sanofi advises health care officials to "carefully consider benefits and risks before administering Vaxelis to persons with a history of:
  • fever of ≥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.
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 article was originally published on PharmacyTimes.com 





Current Issue

The Educated Patient

Emily C. Hayes, PharmD Candidate
Colds, coughs, and a relentless influx of sick patients in retail health clinics keep the health care providers who work there very busy.
Kristen Marjama, DNP, APRN-BC
Although the rate of foot and leg amputation has greatly declined over the past 2 decades, increasing awareness for macrovascular and microvascular complications of diabetes is essential because diabetes is the leading cause of lower-limb amputations in the United States.
Kristen Marjama, DNP, FNP-BC
Gluten proteins found in barley, rye, and wheat trigger systemic injury primarily to the small intestine, but they can also affect the joints, liver, skin, uterus, and other organs.
Kristen Marjama, DNP, FNP-BC
It is that time of year again, when health care providers see an increase in patient volume because no one has time to be sick.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
Cure
MD Magazine
ONCLive
OTCGuide
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Advertise
Careers
Contact Us
Feedback
Privacy
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2018
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.