Dynavax’s Heplisav-B vaccine is a recombinant hepatitis B vaccine that also contains an adjuvant for stimulating a better response. Image Credit: eamesBot / Shutterstock.

The US Food and Drug Administration (FDA) has declined to approve a supplemental biologics licence application (sBLA) for Dynavax Technologies’ recombinant hepatitis B vaccine, Heplisav-B.

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The agency cited insufficient efficacy and safety data due to the “destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial”. The company did not disclose additional details regarding the destruction of trial documents.

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The complete response letter (CRL) issued by the US FDA also went on to state that the “total number of subjects in the single-arm HBV-24 study was deemed to be insufficient to evaluate the safety of the four-dose regimen”.

The sBLA was based on clinical immunogenicity and safety data from the open-label, single-arm Phase I trial (NCT03934736). The study enrolled 119 participants with end-stage renal disease who were undergoing haemodialysis. The sBLA also included data from five other clinical trials for the Heplisav-B vaccine in patients with either chronic kidney disease or undergoing haemodialysis.

Dynavax is no stranger to receiving FDA rejections. The agency rejected Heplisav-B twice due to safety concerns – in 2013 and 2016 – before granting approval for preventing hepatitis B infection in adults in 2017.

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The company’s chief medical officer Rob Janssen said: “We remain confident in the data generated to support HEPLISAV-B vaccination for adult haemodialysis patients. All key data collected in HBV-24 were verified against original source documents during the conduct of the trial.”

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Adding that the company will request a meeting with the FDA to “evaluate options” for additional data needed to support the label expansion for the Heplisav-B vaccine.

Heplisav-B, which is Dynavax’s only marketed vaccine, generated $43.5m in sales in Q1 2024, as per the company’s financials. GlobalData expects the vaccine sales to increase, with the vaccine raking in $700m in 2030.

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Other vaccines in Dynavax’s investigational pipeline include Z-1018, a shingles vaccine, CpG 1018, a plague vaccine being developed in collaboration with the US Department of Defense; and Tdap, a triple immunisation vaccine against tetanus, diphtheria, and pertussis. The company plans to start a Phase I/II trial for the shingles vaccine in Q2. The plague vaccine is being evaluated in a Phase II trial (NCT05506969), with topline data expected in Q4 this year.