Press Release Details

The U.S. FDA approved vaccine is being provided to help protect critical healthcare workers in emergency medical settings from hepatitis B infections

EMERYVILLE, Calif., April 08, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced it is donating 10,000 doses of HEPLISAV-B adult vaccine to help protect healthcare professionals on the front lines of the COVID-19 response against hepatitis B, a potentially deadly virus that is spread through contact with infected blood and bodily fluids and can live on surfaces for at least seven days.

Direct Relief is administering the donation program on behalf of Dynavax.  Interested healthcare providers and facilities throughout the U.S. who are vaccinating surge healthcare workers and hospital staff can visit DirectRelief.org/apply to learn more about accessing the donated vaccine supply of HEPLISAV-B.

“The risk of deadly, blood borne pathogens, like hepatitis B, are greatly increased due to the strained operational and infrastructure issues and rapid deployment of surge healthcare professionals into a stressed environment. With a heightened focus on the respiratory transmission of COVID-19, there is the potential to overlook typical precautions in the emergency setting,” said Dr. Arun Jesudian, Assistant Professor of Medicine at New York-Presbyterian Hospital - Weill Cornell Medicine. “This donation of HEPLISAV-B to help prevent hepatitis B is an effective protection measure we can implement immediately to help keep our front-line healthcare workforce safe.”

According to the World Health Organization, there are 257 million people worldwide living with chronic hepatitis B leading to more than 887,000 deaths annually. The hepatitis B virus is 100 times more infectious than HIV and there is no cure.

“Thousands are risking their lives by stepping up to join the surge healthcare workforce, many who may not have received a complete hepatitis B vaccine series. We must do our part by protecting them from known, vaccine preventable diseases,” said Ryan Spencer, Chief Executive Officer of Dynavax. “That’s why we are donating 10,000 doses of HEPLISAV-B to healthcare providers on the front lines of the COVID-19 response.  As the only Hepatitis B vaccine that offers rapid protection to adults in one month, compared to other hepatitis B vaccines that can take six months or more, our goal is to protect first responders, physicians, nurses, critical care personnel, and hospital staff who deserve every safety measure we can provide.”

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 up to 100 times more infectious than HIV,ⁱ 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.ⁱⁱ 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.ⁱⁱⁱ Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.^iv

Please see Important Safety Information below.

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

About Direct Relief
Direct Relief is a humanitarian aid organization, active in all 50 states and globally, with a mission to improve the health and lives of people affected by poverty or emergencies – without regard to politics, religion, or ability to pay. Direct Relief is coordinating with public health authorities, nonprofit organizations and businesses in the U.S. and globally to provide personal protective equipment and essential medical items to health workers responding to coronavirus (COVID-19).

For more information about Direct Relief, visit https://www.directrelief.org/

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 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 advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships.  For more information, visit www.dynavax.com and follow the company on LinkedIn.

Media Contact
Elizabeth Fatone
ElizabethFatone@SamBrown.com
310-963-5221

Contacts
Nicole Arndt, Senior Manager, Investor Relations
narndt@dynavax.com
510-665-7264

Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com

ⁱ CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm

ⁱⁱ CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm

ⁱⁱⁱ CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf

^iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

Source: Dynavax Technologies Corporation