Benzinga | Feb 19, 2021 12:22PM EST

Dynavax Announces European Commission Marketing Authorization For HEPLISAV B 2 Dose Adult Hepatitis B Adjuvanted Vaccine

EMERYVILLE, Calif., Feb. 19, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that the European Commission (EC) has 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. The approval was issued following the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company's Marketing Authorization Application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials.