Posted by Michael Wonder on 15 Dec 2020
European CHMP adopts positive opinion for Heplisav-B, Dynavax's two dose adult hepatitis B adjuvanted vaccine
10 December 2020 - If approved, Heplisav-B will be the only two dose adult hepatitis B vaccine offering protection in just one month.
Dynavax Technologies today announced that the EMA CHMP has issued a positive opinion on the company's marketing authorisation application, recommending the granting of marketing authorisation for Heplisav-B [Hepatitis B Vaccine (recombinant), adjuvanted] for the active immunisation against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
The CHMP recommendation was based on the assessment of Heplisav-B demonstrated by the safety and immunogenicity results from three Phase 3 clinical trials and post-marketing safety results.
