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FDA Approves Two-Dose Hep B Vaccine

Dynavax news release; 2017 Nov 9

The US Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B vaccine, recombinant (adjuvanted)] for the prevention of hepatitis B infection in adults.

Indications: HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. It is approved for use in adults aged ≥18 years.

Dosage and administration: Administer 2 doses (0.5 mL each) intramuscularly 1 month apart.

Safety/efficacy: The approval of HEPLISAV-B was based on data from 3 phase 3 noninferiority trials of nearly 10,000 adult participants who received HEPLISAV-B showing a protection rate of 95%.

Adverse reactions: The most common local reaction was injection site pain (23%-39%). The most common systemic reactions were fatigue (11%-17%) and headache (8%-17%).

Citation:

Dynavax announces FDA approval of HEPLISAV-B for prevention of hepatitis B in adults. [news release]. Berkeley, CA: Dynavax Technologies Corp. November 9, 2017. http://files.shareholder.com/downloads/DVAX/5565233375x0x963690/63F50A98.... Accessed November 14, 2017.