Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

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%).


Dynavax announces FDA approval of HEPLISAV-B for prevention of hepatitis B in adults. [news release]. Berkeley, CA: Dynavax Technologies Corp. November 9, 2017. Accessed November 14, 2017.

This Week's Must Reads

Must Reads in FDA Actions

FDA Approves Firvanq for C.diff-associated Diarrhea, CutisPharma news release; 2018 Jan 29

FDA Expands Indication for Influenza Vaccine, GSK news release; 2018 Jan 11

FDA Approves Isentress for Tx of HIV in Newborns, Merck news release; 2017 Nov 29

FDA Approves First 2-Drug Regimen for HIV, FDA news release; 2017 Nov 21

FDA Approves Two-Dose Hep B Vaccine , Dynavax news release; 2017 Nov 9