FDA Advisory Committee recommends Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization against hepatitis B.- Dynavax Technologies.

Dynavax Technologies Corporation announced that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that the safety data for Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] support licensure for immunization against hepatitis B infection in adults 18 years of age and older. Three members of the panel abstained. Additionally, the Committee provided commentary on the design of Dynavax's proposed post-marketing pharmacovigilance plan for Heplisav-B. The FDA did not ask this VRBPAC panel to vote on the immunogenicity of Heplisav-B. A prior VRBPAC panel voted 13 to 1 that the data from Phase III clinical trials supports the immunogenicity of Heplisav-B.

Heplisav-B has a Prescription Drug User Fee Act (PDUFA) date of August 10, 2017. If the FDA approves Heplisav -B, Dynavax will seek a recommendation from the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) during its October 2017 meeting. Dynavax plans to launch the vaccine commercially in the U.S. in early 2018 on its own or through a commercial partner.