European Commission Issues Marketing Authorization for an Adult Hepatitis B Adjuvanted Vaccine
Emeryville-based Dynavax Technologies Corporation announced that the European Commission (EC) had granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
On February 19, 2021, the EC marketing authorization approval is valid in all EU and EEA-European Free Trade Association states (Norway, Iceland, and Liechtenstein). It was issued following the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) positive opinion on its marketing authorization application.
Ryan Spencer, CEO of Dynavax, stated in a press release, "With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine."
"We are pleased that HEPLISAV B has received this latest approval and look forward to its launch in Europe expected later in 2021."
The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B, as demonstrated by three Phase 3 clinical trials' safety and immunogenicity results. HEPLISAV-B is now approved in the USA and EU.