Dynavax Technologies Corporation (Nasdaq: DVAX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
EMERYVILLE, Calif., Feb. 28, 2023 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing innovative vaccines, today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials. The approval was issued to Dynavax’s affiliate Dynavax GmbH via the European Commission Decision Reliance Procedure (ECDRP).
Dynavax Announces Great Britain Marketing Authorization for HEPLISAV B®, a 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 Ryan Spencer, Chief Executive Officer of Dynavax. “We are very pleased that HEPLISAV B has received this latest approval and look forward to continuing on-going discussions with potential commercial partners for Great Britain. This approval highlights the capabilities and continued successful execution of the organization.” Please see Important Safety Information below. About Hepatitis B About HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Important Great Britain/MHRA Product Information HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of HEPLISAV B should be in accordance with official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue. Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine. The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness. Immunocompromised persons may have a diminished immune response to HEPLISAV B. Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases. There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine. As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus. The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever. Important U.S. Product Information For full U.S. Prescribing Information for HEPLISAV-B, click here. Important U.S. Safety Information (ISI) 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%). About Dynavax Forward-Looking Statements Contacts: Derek Cole, President
SOURCE Dynavax Technologies | ||
Company Codes: NASDAQ-SMALL:DVAX |
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