Heplisav-B Vaccine Approved for Hepatitis B
November 9, 2017 – The U.S. FDA has approved Heplisav-B™ [hepatitis B vaccine, recombinant (adjuvanted)], manufactured by Dynavax, for the prevention of all subtypes of hepatitis B in adults.
The vaccine contains a hepatitis B surface antigen, and stimulates an increased immune response to the antigen by incorporating a Toll-like receptor (TLR) 9 agonist. Compared to other available hepatitis B vaccines, Heplisav-B requires fewer injections delivered over a shorter amount of time to be effective. Recommended dosing is two intramuscular injections given one month apart. Clinical studies demonstrated a higher rate of efficacy for Heplisav-B when compared to other hepatitis B vaccines.
Hepatitis B is a highly contagious virus that infects the liver. It is typically spread through sexual transmission or contact with blood or other bodily fluids that carry the virus. The majority of people infected with chronic hepatitis B do not experience symptoms. The disease is incurable, and can lead to cancer, liver damage such as cirrhosis, and death.
The first vaccine for hepatitis B became available in 1982. Since most children in the United States receive a hepatitis B vaccine, the majority of new hepatitis B cases diagnosed in the U.S. are found in adults. To help prevent the spread of hepatitis B, the U.S. Centers for Disease Control and Prevention (CDC) recommends that adults who have diabetes or a high risk of contracting hepatitis B (due to lifestyle, occupation, or travel abroad) receive hepatitis B vaccinations.
Heplisav-B is expected to launch during the first quarter of 2018. It is the first new hepatitis B vaccine to become available in the United States in over 25 years.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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