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Dynavax's hepatitis B vaccine gets EU approval

Published on 23/02/21 at 10:29am

The European Commission (EC) has granted marketing authorisation Dynavax Technologies Corporation’s HEPLISAV B vaccine for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of the virus in adults 18 years of age and older.

The approval was issued following a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the company's marketing authorisation application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B, as demonstrated by the safety and immunogenicity results of three Phase III clinical trials.

Hepatitis B, the world’s most common serious liver infection, is a global public health threat. The virus is up to 100 times more infectious than the HIV/AIDS virus, and is also the primary cause of liver cancer (also known as hepatocellular carcinoma), which is the second leading cause of cancer deaths in the world.

The EC’s marketing authorisation approval is valid in all EU member states, as well as the EEA-European Free Trade Association states Norway, Iceland, and Liechtenstein. HEPLISAV-B is now approved in the US and the EU.

Ryan Spencer, Chief Executive Officer of Dynavax, said: “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.

“With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.  We are pleased that HEPLISAV B has received this latest approval and look forward its launch in Europe expected later this year.”

Darcy Jimenez

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