FDA Rejects Heplisav Hepatitis B Vaccine Seeking More Safety Data
- Details
- Category: HBV Vaccines
- Published on Thursday, 28 February 2013 00:00
- Written by Liz Highleyman
The U.S. Food and Drug Administration (FDA) has declined to approve Dynavax Technologies' experimental hepatitis B virus (HBV) vaccine candidate with a toll-like receptor 9 adjuvant, stating it wants to see further data on safety in adults including seniors, the company announced this week.

HIV+ Less Likely to Respond to Hepatitis B Vaccine, but More Shots Increase Protection
- Details
- Category: HBV Prevention
- Published on Friday, 15 February 2013 00:00
- Written by Liz Highleyman
Adults in Kenya responded as well overall to hepatitis B vaccination as people in high-income countries. People with HIV had poorer response, but this could be mostly overcome with repeated doses, according to a study described in the February 1, 2013, Journal of Infectious Diseases.

ICAAC 2012: Hepatitis B Vaccine Effective Long-term, but Some Lose Protection after 15 Years
- Details
- Category: HBV Vaccines
- Published on Tuesday, 11 September 2012 00:00
- Written by Liz Highleyman
Nearly all children who received 3 doses of the Engerix-B hepatitis B vaccine achieved protective immunity, but about 20% fell below the protective antibody threshold by year 15 and could benefit from a booster shot, Canadian researchers reported at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2012) this week in San Francisco. 
Teens Vaccinated Against Hepatitis B as Infants May Lose Immunity
- Details
- Category: HBV Prevention
- Published on Friday, 11 January 2013 00:00
- Written by NIH
Adolescents who received combined active-passive hepatitis B virus (HBV) immunization soon after birth may lose "immunological memory" that protects them from future infection, with the HBeAg status of the mother playing a key role, researchers reported in the January 2013 issue of Hepatology.

Hepatitis B Rates Higher than Expected among Gay Men, Drug Users, Vaccinated Babies
- Details
- Category: HBV Vaccines
- Published on Tuesday, 04 September 2012 00:00
- Written by Liz Highleyman
An unexpectedly high proportion of gay/bisexual men and injection drug users develop chronic hepatitis B rather than clearing the infection, Amsterdam researchers reported in the September 2012 Journal of Hepatology. Other recent studies found that more than one-quarter of children born to mothers with hepatitis B showed evidence of "occult" HBV infection despite vaccination at birth, and that some individuals vaccinated as children may still show evidence of infection as adults.
FDA Committee Says Heplisav Hepatitis B Vaccine Is Effective, but Safety Data Inadequate
- Details
- Category: HBV Vaccines
- Published on Friday, 21 December 2012 00:00
- Written by Dynavax
A U.S. Food and Drug Administration (FDA) committee last month concurred that Dynavax's investigational hepatitis B virus (HBV) vaccine Heplisav was effective in preventing infection, but a majority thought there was not enough data to show whether the vaccine is safe.

Lack of Sleep May Compromise Hepatitis B Vaccine Response
- Details
- Category: HBV Vaccines
- Published on Tuesday, 14 August 2012 00:00
- Written by Liz Highleyman
People who got less than 6 hours of sleep per night showed significantly reduced antibody responses after hepatitis B virus (HBV) vaccination, a finding that may shed light on the well-known association between poor sleep and increased susceptibility to infectious disease, researchers reported in the August 1, 2012, issue of Sleep.
More Articles...
- FDA Will Review New Dynavax Hepatitis B Virus Vaccine
- U.S. Agencies Recommend Blunt Suture Needles to Reduce Risk of Viral Hepatitis and HIV
- CDC Advisory Committee Recommends Hepatitis B Vaccine for People with Diabetes
- ICAAC: Double Dose of Hepislav Works as Well as 3 Doses of Standard HBV Vaccine
- Additional HBV Vaccine Dose Offers More Protection for People with HIV
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