Dynavax Technologies (NASDAQ:DVAX) announces that the Centers for Disease Control and Prevention (CDC) published the Advisory Committee of Immunization Practices’ Recommendations for the use of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for adults in the US in the Morbidity and Mortality Weekly Report (MMWR) dated April 19.
Publication in the MMWR represents the final endorsement that many policies require before reimbursement. HEPLISAV-B was commercially launched in the U.S. in January.
BERKELEY, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) — Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) on November 9, 2017. It is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
“Dynavax is prepared and proud to launch our first product, HEPLISAV-B, in the United States,” said Eddie Gray, chief executive officer of Dynavax. “We believe the increase in the rate of infections and poor compliance with current three-shot regimens has the medical community eager for access to HEPLISAV-B for adults. Given its two-dose schedule and delivery of high rates of protection, HEPLISAV-B is an important tool for preventing hepatitis B in the United States.”
HEPLISAV-B can now be ordered through a network of distributors, which will broaden over the next few weeks. The Wholesale Acquisition Cost (WAC) for HEPLISAV-B of $115 per dose, or $230 per regimen, reflects the value HEPLISAV-B brings to the healthcare system. Dynavax is currently working with an extensive network of group purchasing organizations and government entities to ensure all patients have access to HEPLISAV-B. A list of the current distributors in the Dynavax network can be accessed by calling 1-84-HEPLISAV (1-844-375-4728).
Healthy newborns should receive their first dose of hepatitis B vaccine within the first 24 hours of birth to improve their protection against the enduring and potentially fatal disease, according to an updated policy statement from the American Academy of Pediatrics (AAP).
Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. Chronic infection over the course of a lifetime can lead to liver damage, liver failure, liver cancer, or even death.
Newborns can acquire this infection at birth if a mother is infected with hepatitis B virus. Hepatitis B vaccine administered after birth is highly effective in preventing newborn infection. Yet, approximately 1,000 new cases in infants are identified annually in the United States.
Collaboration to combine Janssen’s vaccine technologies with MVA-BN® technology from Bavarian Nordic to advance potential new vaccine regimens
RARITAN, NJ – July 26, 2017 – Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide exclusive license and collaboration agreement with Bavarian Nordic to leverage their MVA-BN® technology with Janssen’s own AdVac® and DNA-based vaccine technologies in the development and commercialization of potential new vaccine regimens against hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1). This agreement stems from successful and ongoing collaborations between the companies to develop vaccines to address Ebola and Human Papillomavirus (HPV).
Abstract #1766 Hepatitis A and B Vaccination Rates in Patients with Chronic Liver Disease: A Quality Improvement Project – Mooz Sial, et al.
Vaccination against hepatitis A and B is recommended for people with chronic liver disease (CLD). This retrospective study examined medical records of 300 people with CLD from 2013 through 2014. They identified patients who did not appear to be immune to hep A and/or hep B. Hep A vaccine was recommended in 35%; hepatitis B vaccine in 36% patients. Of these, 12% forgot to get it, 33% didn’t recall being advised, and 55% gave no specific reason as to why they didn’t get vaccinated.
Conclusion: The rate of hepatitis A and B immunization in patients with chronic liver disease needs to be improved.
Editorial Comments: Immunization is a basic, cost-effective, and necessary way to protect people from diseases. It’s discouraging to think that people with CLD aren’t getting their hep A and B vaccinations.
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com
Biotech Dynavax Technologies (NASDAQ:DVAX) soared Thursday, even as the market overall crashed, after its hepatitis B vaccine beat GlaxoSmithKline’s (NYSE:GSK) standard product in a late-stage clinical trial.
Dynavax said that its vaccine, Hepislav-B, showed a 95.4% rate of peak seroprotection, in contrast with only 81.3% for Glaxo’s Engerix-B. Dynavax focused especially on patients with diabetes mellitus, who don’t respond well to current vaccines and treatments. In the study, the seroprotection rate for Hepislav-B was 90%, as opposed to Engerix-B’s 65.1%.
The study also showed that the two vaccines had similar safety profiles. A number of adverse events occurred in both arms, mostly autoimmune-related, but Dynavax said that they were not related to vaccinations.