Dynavax and Times Pharmacy Announce Partnership to Offer HEPLISAV-B® Hepatitis B Vaccine to Customers Throughout Oahu, with a Focus on People with Diabetes

Berkeley, California, UNITED STATES

-   People with diabetes are two times more likely to become infected with the hepatitis B virus (HBV) and up to four times as likely to get HBV-related liver cancer

-   Hawaii has one of the highest rates of liver cancer in the U.S. and hepatitis B is a leading cause

EMERYVIILLE, Calif., July 10, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation, a biopharmaceutical company focused on developing and commercializing novel vaccines, and Times Pharmacy, have partnered with Hep Free Hawaii to provide HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] at pharmacy locations on Oahu, with a focus on people living with diabetes. Through this partnership, pharmacy customers will have access to HEPLISAV-B, the only FDA-approved two-dose hepatitis B vaccine for adults that is completed in one month. HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

“Our goal is to eliminate hepatitis B in Hawaii, which includes vaccinating at-risk populations, such as people with diabetes,” said Thaddeus Pham, co-Founder and co-Director of the Hep Free Hawaii Coalition. “Preventing hepatitis B through immunization is an important part of preventive care and is critical to slowing the spread of hepatitis B, which will also help protect against new cases of liver cancer.”

It is estimated that half of the adults in Hawaii have type 2 diabetes or prediabetesi, which lowers the efficiency of the immune system and can make people more susceptible to viral infections, such as hepatitis B. Hepatitis B is also one of the leading causes of liver cancer and Hawaii has the second highest number of cases of liver cancer and deaths in the U.S.ii

“At Times Pharmacy, our customers are relying on us more than ever, and this partnership further demonstrates our commitment to providing them the best care possible,“ said Melissa Machida, Clinical Pharmacy Manager at Times Pharmacy. “One way to help protect our customers from the long-term consequences of this vaccine-preventable disease, such as cirrhosis and liver cancer, is to provide immunization from hepatitis B. HEPLISAV-B is a two-dose vaccination series spaced apart by only one month, providing higher protection rates than previous hepatitis B vaccination options.”

Hepatitis B is a liver infection caused by the hepatitis B virus (HBV). In the U.S., it is estimated that 15 to 25 percent of patients with chronic hepatitis B develop chronic liver disease, including cirrhosis, liver failure, or liver cancer.iii People living with diabetes are at increased risk for hepatitis B since the hepatitis B virus can be spread through everyday disease management activities such as sharing blood glucose meters, fingerstick devices or other diabetes-care equipment including syringes or insulin pens.iv The CDC recommends HBV vaccination for all adults with diabetes who are younger than 60 years old.v

“Community pharmacists see their patients regularly and, as such, they play such a critical role when it comes to vaccinating patients in their neighborhood,” said Donn Casale, Vice President, Commercial of Dynavax. “We are pleased Times Pharmacy recognized that HEPLISAV-B can provide the fastest and highest rates of protection for their customers at risk.”

Vaccination with HEPLISAV-B will be available at four Times Pharmacy locations including Times Koolau, Times Waimalu, Times Kunia, and Times Kamehameha Shopping Center locations during normal business hours and no appointments are necessary. Private insurers, Medicare and Medicaid are required to cover preventative HBV testing and vaccines, usually without a deductible or co-pay. Payer coverage for HEPLISAV-B has been established for 100% of Medicare lives, more than 95% of Commercial lives, and 90% of Medicaid fee-for-service lives. Times Pharmacy is practicing COVID 19 safety measures.

Please see Important Safety Information below. 

For more information about HEPLISAV-B, visit http://heplisavb.com/.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,vi and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.vii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.viii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.ix

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use 
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also further developing CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19 and pertussis. For more information, visit www.dynavax.com and follow the company on LinkedIn.

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i Hawaii State Department of Health. https://www.healthyhawaii.com/prevent-diabetes-2/
ii CDC. https://gis.cdc.gov/Cancer/USCS/DataViz.html
iii CDC. https://www.cdc.gov/hepatitis/abc/index.htm
iv CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf
v CDC. https://www.cdc.gov/hepatitis/populations/diabetes.htm
vi CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm
vii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm
viii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf
ix CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf