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Exhibit 99.1 VBI Press Release VBI Vaccines Announces FDA Approval of PreHevbrio ™ for the Prevention of Hepatitis B in Adults PreHevbrio ™ is the only approved 3 - antigen hepatitis B vaccine for adults in the U.S. Shareholder conference call to be held today , December 1 , at 8:30 AM ET CAMBRIDGE , Mass . ( December 1 , 2021 ) – 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 U.S. Food and Drug Administration ( FDA ) has approved PreHevbrio ™ [ Hepatitis B Vaccine ( Recombinant ) ] for the prevention of infection caused by all known subtypes of hepatitis B virus ( HBV ) in adults age 18 years and older . PreHevbrio contains the S , pre - S2 , and pre - S1 HBV surface antigens , and is the only approved 3 - antigen HBV vaccine for adults in the U.S. " As we work to implement the ACIP's new universal hepatitis B vaccine recommendation for all adults ages 19-59 , as voted on in November , we benefit from having more tools , including this newly approved 3 - antigen hepatitis B vaccine , " said Chari Cohen , DrPH , MPH , Senior Vice President of the Hepatitis B Foundation . “ Having more vaccine options will help us effectively expand vaccine uptake , ensure more people are protected from hepatitis B infection , and reach the 2030 goal of eliminating hepatitis B in the U.S. ” Jeff Baxter , VBI's President and CEO , commented : " We are proud to announce the approval of PreHevbrio , VBI's first FDA - approved vaccine . This is a substantial achievement that demonstrates the VBI team's ability to progress vaccine candidates from the clinic through to approval . This approval , however , is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections . We would like to thank the study participants , clinical site investigators , our employees , and all who contributed to this achievement , and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B. " The approval of PreHevbrio was based on the results from two Phase 3 clinical studies , PROTECT and CONSTANT , data from which were published , respectively , in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. The pivotal studies compared PreHevbrio to Engerix - B , a single - antigen HBV vaccine . Data from the PROTECT study showed that PreHevbrio 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 expects to make PreHevbrio available in the U.S. in the first quarter of 2022 , and has partnered with Syneos Health for the past two years to ensure commercial readiness . Outside of the U.S. , VBI continues to support the European Medicines Agency's ( EMA ) ongoing review of the marketing authorization application for VBI's 3 - antigen HBV vaccine . VBI expects to complete regulatory submissions to the United Kingdom's Medicines and Healthcare products Regulatory Agency ( MHRA ) and to Health Canada in 2022 . Conference Call Details VBI Vaccines will host a conference call on Wednesday , December 1 at 8:30 AM ET . The live call can be accessed via the Events / Presentations page in the investors section of the Company's website , or by clicking this link : https://viavid.webcasts.com/starthere.jsp?ei=1517423&tp_key=00a076a769 . A replay of the conference call will be archived on the Company's website following the live call . To listen to the live conference call , please dial : Toll - free U.S. & Canada Dial - In : 877-705-6003 International Dial - In : 201-493-6725 Conference ID : 13725342 Indication and Use PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus . PreHevbrio is approved for use in adults 18 years of age and older . Important Safety Information ( ISI ) Do not administer PreHevbrio 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 PreHevbrio . Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio . Immunocompromised persons , including those on immunosuppressant therapy , may have a diminished immune response to PreHevbrio . PreHevbrio may not prevent hepatitis B infection , which has a long incubation period , in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration . The most common side effects ( > 10 % ) in adults age 18-44 , adults age 45-64 , and adults age 65+ were pain and tenderness at the injection site , myalgia , fatigue , and headache . There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy . Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 ( toll - free ) . To report SUSPECTED ADVERSE REACTIONS , contact VBI Vaccines at 1-888-421-8808 ( toll - free ) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov Please see full Prescribing Information . 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 .