VBI Vaccines Announces European Commission Marketing Authorisation for PreHevbri™, a 3-Antigen Adult Hepatitis B Vaccine
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the European Commission (EC) has granted Marketing Authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can also be expected that hepatitis D will be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations. PreHevbri contains the full antigenic composition of the hepatitis B virus surface antigen, including the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the European Union (EU) and in the European Economic Area (EEA) countries – Iceland, Liechtenstein, and Norway.
“We are excited to be able to announce the approval of PreHevbri in Europe, marking our second major approval for this differentiated HBV vaccine in five months, following the U.S. FDA approval at the end of November last year,” said Jeff Baxter, VBI’s President and CEO. “Hepatitis B is a highly infectious, under-reported, persistent public health problem in Europe and we believe PreHevbri has the potential to be a meaningful new tool for healthcare providers as they endeavor to fight it. We are committed to being part of this fight and are working hard to make PreHevbri available in different European countries as quickly as possible.”
The European Commission’s centralized marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway). VBI expects to make PreHevbri available in certain European countries beginning at the end of 2022.
The approval follows a positive opinion granted in February 2022 by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which was based on the positive results from two pivotal, randomized, double-blind, controlled Phase 3 clinical studies, PROTECT and CONSTANT. Data from these studies were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. Both studies compared PreHevbri to Engerix-B, a single-antigen HBV vaccine. Results from the PROTECT study showed that PreHevbri elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.
VBI continues to support the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) review as part of the EC Decision Reliance Procedure (ECDRP), which was initiated upon receipt of the positive CHMP opinion in February.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United States, and Israel. The brand names for this vaccine are : PreHevbri™ (EU/EEA), PreHevbrio™ (US), and Sci-B-Vac® (Israel).
Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu.
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, visit www.vbivaccines.com.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005250/en/
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FIFA Announces AB InBev as Official Beer Sponsor of FIFA Women’s World Cup 2023™ and FIFA World Cup 2026™8.6.2023 14:00:00 EEST | Press release
AB InBev (Euronext: ABI) (MEXBOL: ANB) (JSE: ANH) (NYSE: BUD), the world’s leading brewer, has extended its nearly 40-year partnership with FIFA as the official beer sponsor of the FIFA Women’s World Cup 2023™ and the FIFA World Cup 2026™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005239/en/ (Graphic: Business Wire) The two tournaments will make history with notable firsts, providing AB InBev and its leading brands with new opportunities to brew excitement for fans all around the world. The FIFA Women’s World Cup™ will make its debut in the southern hemisphere in Australia and Aotearoa New Zealand next month, with 32 teams also taking part in the competition for the first time. The FIFA World Cup 2026™, meanwhile, will be the first to be hosted by three countries, with 48 participating teams and 104 matches in 16 cities across Canada, Mexico and the United States. “FIFA World Cup tournaments are the most popular s
The IKEA Foundation Pledges More Than €11 Million in Emergency Humanitarian Aid for Sudan8.6.2023 13:23:00 EEST | Press release
The IKEA Foundation has donated €5 million to Médecins Sans Frontières - Doctors Without Borders (MSF) to provide urgent medical care and supplies to people affected by the recent fighting in Sudan. It has also donated €6.7 million to Better Shelter to deploy 3,000 units to meet the immediate shelter needs of people displaced by the deadly conflict. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005375/en/ Illustration of fighting in Khartoum, Sudan Copyright: MSF/Atsuhiko Ochiai Countries: Sudan Date taken / Date Recorded: 04 May, 2023 Caption / Description: Aerial view captures the fighting and violence that erupted in Khartoum, Sudan. (Photo: Business Wire) Intense fighting broke out in Khartoum, Sudan on 15 April and has since spread to other parts of the country. Local hospitals have been overwhelmed as people arrive with serious injuries caused by gunshots, explosions and airstrikes. The country’s health system,
Digital Water Saves Millions for Communities, According to Leading Utilities8.6.2023 13:00:00 EEST | Press release
Leading water utilities are increasingly embracing data analytics and digital technology to optimize their operations, save millions for communities and increase water networks’ resilience to climate change. Insights from 18 global water utility leaders and experts that are influential in early-stage digital adoption are featured in a new paper from water technology leader Xylem (NYSE: XYL) and Bluefield Research. These utility experts share perspectives on how “going digital” is helping them to solve big water challenges in their communities. Their shared expertise provides a blueprint to accelerate the modernization of 400,000 water, wastewater, and stormwater systems worldwide. Utilities that participated in the paper implemented digital technology to save billions of gallons of water, prevent millions of gallons of sewer overflow pollution, and save millions of dollars in energy costs. For example, in Cincinnati, Ohio, the Metropolitan Sewer District of Greater Cincinnati used data
LTIMindtree and SNP Partner To Launch “Fast Forward” For BLUEFIELD™ Implementation8.6.2023 12:45:00 EEST | Press release
LTIMindtree [NSE: LTIM, BSE: 540005], a global technology consulting and digital solutions company, in collaboration with SNP Schneider-Neureither & Partner SE (ISIN: DE0007203705), a world-leading provider of software solutions for digital transformation processes, automated data migrations and data management in the SAP environment, today announced the launch of “Fast Forward” for BLUEFIELD™ implementation, powered by SNP’s proprietary approach. The joint offering – “Fast Forward” – is a full lifecycle solution built to accelerate an enterprise’s migration to the SAP S/4HANA platform with minimal risk, while retaining the golden nugget of existing ERP. It combines LTIMindtree’s global S/4HANA capability and industry knowledge with SNP’s CrystalBridge® platform and Rapid Empty Shell Creation technology to transform existing SAP investments without having to fully redesign their legacy systems. As part of the partnership, LTIMindtree and SNP will also set up a joint innovation center t
SAP S/4HANA is Driving Nordics in a Digital Direction8.6.2023 11:00:00 EEST | Press release
Enterprise demand for SAP transformation services in the Nordics has grown exponentially over the past 12 months, as companies seek industry-specific solutions and accelerate their cloud transformations, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2023 ISG Provider Lens™ SAP Ecosystem report for the Nordics finds the planned phase-out of support for SAP’s ERP Central Component (ECC) in 2027 has led to increased adoption of SAP S/4HANA. In the Nordic region, RISE with SAP, a unified ERP-as-a-service offering, has played a major role in enterprises embracing SAP in the cloud. “There is a rising call in the Nordics for increased SAP cloud services,” said Anthony Drake, ISG director, North Europe. “Providers have responded by extending their partnerships both with SAP and with hyperscalers.” Expansion of the SAP market has led to a growing focus on certification and trainin
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom