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# FDA Sets Panel Meeting for Dynavax Resubmission
- URL: https://www.fdaweb.com/fda-sets-panel-meeting-for-dynavax-resubmission/
- Published: 2017-04-03T12:00:00.000Z
- Updated: 2026-09-14T22:15:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138363

FDA has told Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the company’s BLA for Heplisav-B \[hepatitis Bb vaccine, recombinant (adjuvanted)\], a vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The agency has set a user fee review target of 8/10 for the submission.

Earlier this year, FDA accepted the submission after it addressed an 11/2016 Complete Response Letter (CRL) on the product. The letter ([see earlier story](https://www.fdaweb.com/fda-rejects-dynavax-bla-on-heplisav-b/)) had sought clarification about “specific adverse events of special interest” (AESIs), and a numerical imbalance in a small number of cardiac events in a single study, according to the company. It also asked for new analyses of the integrated safety data base across different time periods, and post-marketing commitments. “In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events,” the company said at the time.

  
In 2013, the agency issued Dynavax a CRL on the BLA, which specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group, according to the company. “The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events,” it said at the time. In 2012, FDA’s Vaccines and Related Biological Products Advisory Committee voted (13 to 1) that the vaccine adequately demonstrated immunogenicity. However, the panel voted 8 to 5 with one abstention that there were insufficient data to adequately support the product’s safety.