FDA Accepts for Review a BLA for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine

Merck (MSD outside the US and Canada) and Sanofi Pasteur, the vaccines division of Sanofi, have announced that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine,
DTaP5-IPV-Hib-HepB1 , has been accepted for review by FDA. If approved, it would be the first pediatric combination vaccine in the US designed to help protect against six important diseases — diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus
influenzae type b (Hib), and hepatitis B.

“We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases,” said Robin Isaacs,Vice President, Vaccine Clinical Research, Merck Vaccines.

“Leading organisations — the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians — generally recommend the use of combination vaccines instead of individual injections,” said John Shiver, Senior Vice President, Research and Development, Sanofi Pasteur.