Merck and Sanofi Pasteur have received approval for review from US Food and Drug Administration (FDA) for investigational paediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB.
The FDA accepted the biologics licence application (BLA) for the vaccine, which is being developed to treat six diseases such diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Merck Vaccines clinical research vice-president Robin Isaacs said: "We are excited about reaching another key milestone in the development of this investigational paediatric vaccine against six important diseases."
According to Merck, the treatment would be the first paediatric combination vaccine in the US to help protect against six diseases, if approved.
The Phase III trial data for the investigational paediatric hexavalent vaccine was recently presented at IDWeek in Philadelphia.
The trial included more than 400 infants at multiple centres across the US, which assessed the safety and immunogenicity of the vaccine against licenced comparator vaccines.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSanofi Pasteur research and development senior vice-president John Shiver said: "Leading organizations including 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."
Image: Haemophilus influenzae bacteria cultured on blood. Photo: courtesy of MarcoTolo.
