FDA to review application for investigational pediatric hexavalent vaccine

The U.S. Food and Drug Administration (FDA) recently agreed to review a Biologics License Application filed by Merck and Sanofi Pasteur regarding an investigational pediatric hexavalent vaccine.

The vaccine is a pediatric combination vaccine that is intended to protect against diphtheria, tetanus, pertussis, polio, invasive disease caused by Haemophilus influenzae type b and hepatitis B.

A recent Phase III clinical study evaluating the safety and immunogenicity of the pediatric combination vaccine showed encouraging results as similar immune responses against antigens were detected in both the investigational vaccine and licensed comparator vaccines.

Organizations such as the Advisory Committee on Immunization Practices and the American Academy of Pediatrics often recommend the use of combination vaccines instead of individual injections, so the FDA accepting the application for review is promising.

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

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Merck U.S. Food and Drug Administration (FDA)

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