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# FDA Approves Dynavax BLA for Hepatitis B Vaccine
- URL: https://www.fdaweb.com/fda-approves-dynavax-bla-for-hepatitis-b-vaccine/
- Published: 2017-11-10T12:00:00.000Z
- Updated: 2026-09-14T23:01:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140105

FDA has approved a Dynavax Technologies BLA for Heplisav-B \[hepatitis b vaccine, recombinant (adjuvanted)\] for immunization against hepatitis B infection in adults 18 years of age and older. Approval was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adults who received Heplisav-B. Pivotal studies compared the vaccine administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule, according to the company. “Results from the largest Phase 3 trial, which included 6,665 participants, showed that Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B,” it says.