Hepatitis B vaccine(Takeda Pharmaceutical Co., Ltd.)

Safe vaccination, testing and treatment options widely availableJEFFERSON CITY, Mo., May 17, 2024 (GLOBE NEWSWIRE) -- May is Hepatitis Awareness Month, the perfect time for individuals to talk to their health care providers about hepatitis vaccinations. Hepatitis is an inflammation of the liver caused by a virus. The liver is a vital organ that processes nutrients, filters the blood and fights infections. When the liver is inflamed or damaged, its function can be affected. In many cases, people who contract hepatitis do not show any symptoms and do not know they are infected. Receiving a hepatitis vaccination is the most effective way to protect oneself from contracting and spreading the virus. There are three common strains of hepatitis in the United States: hepatitis A, hepatitis B and hepatitis C. Vaccines are available for both hepatitis A and hepatitis B, whereas hepatitis C is generally curable with treatment. Hepatitis A: Is spread when someone ingests the virus through close, personal contact with an infected person, or by eating contaminated food or drink. The hepatitis A vaccine is available and requires two doses, given six months apart. Receiving both doses provides the best protection. Hepatitis B: Is spread when bodily fluids from a person infected with the hepatitis B virus enter the body of someone who is not infected. The hepatitis B vaccine is available for all age groups, given as a series of two, three or four doses. There is also a vaccine available that protects adults from both hepatitis A and hepatitis B. This combined vaccine is usually given as three separate doses over a six-month period. Both the hepatitis A and hepatitis B vaccines are safe and proven effective. Hepatitis C: Is spread when blood from a person infected with the hepatitis C virus enters the body of someone who is not infected. Although there is no vaccine, it is curable in more than 95% of cases. Individuals are encouraged to talk to their health care provider about testing for hepatitis C. For those ages 18 and up in the Jefferson City area, the Missouri Department of Health and Senior Services is hosting a free hep C testing event from 11 a.m. to 1 p.m. CST on Monday, May 20 on the South Lawn of the Capitol. Most health insurance plans cover these vaccines. Families should check with their insurance provider on potential costs and where to get the vaccines. The Vaccines for Children Program, funded by the CDC, provides free vaccines to children who qualify. Parents or guardians can talk with a provider to determine eligibility. Additionally, most local public health agencies throughout the state of Missouri offer vaccinations at affordable rates. To find a local public health agency near you and schedule an appointment, visit the Local Public Health Agency Directory. Mission of the Missouri Department of Health and Senior Services (DHSS): To promote health and safety through prevention, collaboration, education, innovation and response. MEDIA CONTACT:Lisa CoxMissouri Department of Health and Senior ServicesMedia Inquiry Form

Dynavax’s Heplisav-B vaccine is a recombinant hepatitis B vaccine that also contains an adjuvant for stimulating a better response. Image Credit: eamesBot / Shutterstock. The US Food and Drug Administration (FDA) has declined to approve a supplemental biologics licence application (sBLA) for Dynavax Technologies ’ recombinant hepatitis B vaccine, Heplisav-B. The agency cited insufficient efficacy and safety data due to the “destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial”. The company did not disclose additional details regarding the destruction of trial documents. The complete response letter (CRL) issued by the US FDA also went on to state that the “total number of subjects in the single-arm HBV-24 study was deemed to be insufficient to evaluate the safety of the four-dose regimen”. The sBLA was based on clinical immunogenicity and safety data from the open-label, single-arm Phase I trial (NCT03934736). The study enrolled 119 participants with end-stage renal disease who were undergoing haemodialysis. The sBLA also included data from five other clinical trials for the Heplisav-B vaccine in patients with either chronic kidney disease or undergoing haemodialysis. Dynavax is no stranger to receiving FDA rejections. The agency rejected Heplisav-B twice due to safety concerns – in 2013 and 2016 – before granting approval for preventing hepatitis B infection in adults in 2017. See Also: FDA clears IND for Verismo Therapeutics’ CAR-T therapy Circular RNA: Vaccines, therapeutics and biomarkers could be revolutionised The company’s chief medical officer Rob Janssen said: “We remain confident in the data generated to support HEPLISAV-B vaccination for adult haemodialysis patients. All key data collected in HBV-24 were verified against original source documents during the conduct of the trial.” Adding that the company will request a meeting with the FDA to “evaluate options” for additional data needed to support the label expansion for the Heplisav-B vaccine. Heplisav-B, which is Dynavax’s only marketed vaccine, generated $43.5m in sales in Q1 2024, as per the company’s financials. GlobalData expects the vaccine sales to increase, with the vaccine raking in $700m in 2030. GlobalData is the parent company of Pharmaceutical Technology. Other vaccines in Dynavax’s investigational pipeline include Z-1018, a shingles vaccine, CpG 1018, a plague vaccine being developed in collaboration with the US Department of Defense; and Tdap, a triple immunisation vaccine against tetanus, diphtheria, and pertussis. The company plans to start a Phase I/II trial for the shingles vaccine in Q2. The plague vaccine is being evaluated in a Phase II trial (NCT05506969), with topline data expected in Q4 this year.