09:59 AM EDT, 05/14/2024 (MT Newswires) -- Dynavax Technologies ( DVAX ) said Tuesday that it has been notified by the US Food and Drug Administration that its supplemental biologics license application to include a four-dose HEPLISAV-B hepatitis B vaccine did not provide sufficient data to support its full evaluation.

The commercial-stage company said the response from the FDA has no impact on the approved indication for HEPLISAV-B in the US, the EU, and Great Britain. The vaccine is intended to prevent infection caused by all known subtypes of hepatitis B virus in adults.

Shares of Dynavax ( DVAX ) were down nearly 2% in recent trading.

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