VBI Vaccines Inc. has announced the receipt of positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medical Agency (EMA) regarding the company’s development path for its Sci-B-Vac vaccine in Europe.
Sci-B-Vac is a third-generation hepatitis B vaccine with demonstrated safety and efficacy in more than 300,000 patients in currently licensed markets.
In its letter, the CHMP expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac.
The CHMP also agreed that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorisation application (MAA) for Sci-B-Vac.
“Sci-B-Vac has an extensive safety and efficacy track record in more than 22 clinical studies in more than 4000 children and adults,” said Francisco Diaz-Mitoma, MD, PhD, VBI’s Chief Medical Officer. “We are encouraged by the feedback received by the CHMP at EMA, and believe VBI is now well-positioned to advance its pivotal studies in Europe to obtain registration and licensure of Sci-B-Vac.”
In parallel, VBI is evaluating plans for the pivotal Phase III clinical studies with the US Food and Drug Administration (FDA) and Health Canada. VBI plans to provide additional information about the clinical studies upon completion of further regulatory agency discussions.
About Sci-B-Vac: Sci-B-Vac is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in more than 300,000 patients. Sci-B-Vac™ is currently approved for use in Israel and in 14 other countries.
In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac may prove to be more immunogenic in subjects that currently do not respond optimally to second-generation vaccines.