Novel Pediatric Hexavalent Vaccine Now Under FDA Review

The FDA is reviewing a Biologics License Application for the first pediatric combination vaccine designed to help protect against 6 diseases.

Sanofi’s vaccines division and Merck jointly announced today that the FDA is reviewing their Biologics License Application for the first pediatric combination vaccine designed to help protect against 6 diseases.

The investigational hexavalent vaccine includes antigens for diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), Haemophilus influenzae type b, and hepatitis B.

In their application for the drug’s FDA review, Merck and Sanofi Pasteur included data from a phase 3 study presented at IDWeek 2014 that evaluated the safety and immunogenicity of their investigational pediatric hexavalent vaccine administered at 2, 4, and 6 months of age. The results of the trial demonstrated similar immune responses to the antigens covered by the 2 companies’ DTaP5-IPV-Hib-HepB vaccine compared with those included in licensed comparator vaccines.

The most common adverse events following any dose of the investigational hexavalent vaccine were irritability (83%), crying (75%), and drowsiness (74%).

“We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against 6 important diseases,” said Robin Isaacs, MD, vice president of vaccine clinical research for Merck Vaccines, in a statement.