> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Panel Backs Dynavax Hepatitis B Vaccine
- URL: https://www.fdaweb.com/fda-panel-backs-dynavax-hepatitis-b-vaccine/
- Published: 2017-07-31T12:00:00.000Z
- Updated: 2026-09-14T22:37:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139263

FDA’s Vaccines and Related Biological Products Advisory Committee has voted 12 to 1 to recommend approval of 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. The positive vote came despite safety concerns from FDA medical reviewers. The reviewers’ assessment, which is in a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM568492.pdf?ref=fdaweb.com) released in advance of the 7/28 meeting, noted that there were more deaths and serious cardiac events in clinical trial patients who received Heplisav than in those who received GlaxoSmithKline’s Energix-B, a comparator product. However, the reviewers also said that overall numbers and rates of adverse events were low, and there were limitations in the evaluation of cardiac events that “limits the causal interpretation of these observations.”

  
If FDA approves the vaccine, Dynavax says it will seek a recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) during its October meeting.