European CHMP Adopts Positive Opinion for HEPLISAV-B®, Dynavax's Two Dose Adult Hepatitis B Adjuvanted Vaccine
"Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it can be prevented with effective vaccination," commented
Please see Important Safety Information below.
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, 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.
About HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with
Indication and Use in Approved
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%).
This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to be approved for marketing in the EU in the first quarter of 2021. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, whether and when HEPLISAV-B will be approved for marketing in the EU, and if approved, whether we will successfully commercialize it in the EU, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
In the EU, HEPLISAV-B is investigational and not approved. Its efficacy and safety have not been established. More information about clinical trials with HEPLISAV-B is available at www.clinicaltrials.gov.
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