PreHevbri™ (Sci-B-Vac) Vaccine Description For 2022
VBI Vaccines Inc.'s PreHevbri™ (Sci-B-Vac) is a 3rd generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S, of the hepatitis B virus ("HBV"). Sci-B-Vac has demonstrated safety and efficacy in over 500,000 patients. In addition, VBI's enveloped virus-like particle (eVLP) platform technology enables the development of eVLPs that closely mimic the target virus to elicit a potent immune response.
And the PreHevbri (Sci-B-Vac) vaccine is U.S. FDA authorized (STN: 125737) and commercially available in Israel and 14 other countries. PreHevbrio is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.
In Dec. 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study. During an Aug. 2020 presentation, Adam Finn, M.D., Ph.D., Professor of Paediatrics at the University of Bristol, UK, and principal investigator of the CONSTANT Phase 3 clinical study, discussed the successfully-met primary endpoint of CONSTANT – demonstration of the consistency of immune response as measured by the geometric mean concentration (GMC) of hepatitis B antibodies (anti-HBs titers) across three consecutively-manufactured lots of Vaccine.
Additional data highlighted included: High anti-HBs titers: GMC of anti-HBs for Sci-B-Vac was more than 7.5x compared to Engerix-B after two vaccinations (day 168) and more than 3x after three vaccinations (day 196); Rapid Onset of Seroprotection: After two vaccinations, Sci-B-Vac elicited a 90.4% seroprotection rate (SPR) compared to 51.6% with Engerix-B, increasing to 99.3% vs. 94.8% after the 3rd dose.
On Feb. 2, 2021, the U.S. FDA accepted the Biologics License Application filing. Then, on Dec. 1, 2021, the FDA approved PreHevbrio to prevent infection caused by all known subtypes of HBV in adults. On Jan. 12, 2022, Francisco Diaz-Mitoma, M.D., Ph.D. – Chief Medical Officer, VBI, presented 'Safety & Immunogenicity of a 3-Antigen Hepatitis B Vaccine, PreHevbri during the U.S. CDC's Advisory Committee on Immunization Practices meeting. On Feb. 23, 2022, LCDR Mark K. Weng, MD MSc, CDC Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices, presented PreHevbrio for adult hepatitis B vaccination Evidence to Recommendation and GRADE. Following a positive vote, PreHevbrio is now recommended for prophylactic adult vaccination against HBV infection.
On May 2, 2022, the Company announced that the European Commission granted Marketing Authorisation for PreHevbri for active immunization against infection caused by all known subtypes of HBV in adults. And on Sept. 8, 2022, Valneva SE and VBI Vaccines Inc. announced a partnership in select European markets for the marketing and distribution of PreHevbri®. The brand names for this vaccine are PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).
Massachusetts-based VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. Through its innovative approach to VLPs, including a proprietary enveloped VLP platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.
As of Sept. 21, 2022, PreHevbrio was available in Europe, the USA, and the U.K. under the Sci-B-Vac® brand in Israel. PreHevbri was approved by the European Commission and the United Kingdom Medicines and Healthcare products Regulatory Agency in the second quarter of 2022 for active immunization against infection caused by all known subtypes of HBV in adults. Valneva SE will lead marketing activities in the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in early 2023.
Please visit www.PreHevbrio.com for U.S. Safety Information for PreHevbrio, or please see U.S. Full Prescribing Information. In addition, a full European Summary of Product Characteristics for PreHevbri is available from the European Medicines Agency website.
HBV infection is the leading cause of liver disease, and, with current treatments, it is challenging to cure, with many patients developing liver cancers. An estimated 900,000 people die each year from complications of chronic HBV, such as liver decompensation, cirrhosis, and hepatocellular carcinoma. The U.S. CDC. Sci-B-Vac is indicated to prevent hepatitis B in adults 18 and older. It can also be expected that hepatitis D will be controlled by immunization with PreHevbri, as hepatitis D does not occur without hepatitis B infection.
On Oct. 12, 2021, the JAMA Network published an Original Investigation: Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs. a Single-Antigen Hepatitis B Vaccine, phase 3 study. It found the 3-antigen HBV vaccine had higher seroprotection rates after the second and third vaccinations than the single-antigen HBV vaccine.
It is administered 10ug, IntraMuscular injection as a solution on Days 0, 28, and 168. Sci-B-Vac is currently in two Phase 3 clinical trials to support Sci-B-Vac licensure in the U.S., Europe, and Canada. In addition, it can be administered at lower doses than competing hepatitis B vaccines, says the Company.
PreHevbri Side Effects
The safety and tolerability seen in a phase 3 study support the safety profile of VBI's 3-antigen vaccine candidate – with no safety signals observed in either study arm and no new safety risks identified. However, do not administer PreHevbrio to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or any component of PreHevbrio.
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.
VBI Vaccines Inc. Financial News (Nasdaq: VBIV) 2021 - 2022
September 15, 2022 - VBI Vaccines Inc. entered into a debt facility of up to $100 million.
September 8, 2022 - Under the terms of a new agreement, Valneva will promote and distribute PreHevbri throughout select European countries.
March 7, 2022 - VBI Vaccines Inc. reported financial results for 2021. Revenue for 2021 was $0.6 million compared to $1.1 million for 2020. The decrease in revenue was due to a reduction in the R&D services revenue earned as part of the License Agreement with Brii Bio in 2021 compared to 2020. And VBI announced that PreHevbrio's U.S. commercial launch is expected at the end of March 2022. Through a partnership with Syneos Health, PreHevbrio is expected to generate revenue in Q2 2022.
November 8, 2021 - VBI Vaccines Inc. reported financial results for the third quarter ending September 30, 2021, and provided a corporate update. VBI ended the third quarter of 2021 with $137.5 million in cash, cash equivalents, and short-term investments compared with $93.8 million as of December 31, 2020.
March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter and twelve months that ended December 31, 2020.
PreHevbri News For 2020 - 2022
September 21, 2022 - VBI Vaccines Inc. announced that data from the physician-initiated compassionate use of VBI’s 3-antigen hepatitis B vaccine in four adults chronically infected with the HBV were presented in a poster session at the 2022 International HBV Meeting in France.
September 8, 2022 - Jeff Baxter, President, and CEO of VBI, commented: "This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries where we expect to launch, which will be of critical value as we work collectively to provide broad access to this differentiated 3-antigen HBV vaccine in Europe. Strategically, VBI and Valneva are two companies aligned by a shared mission to reduce the burden of infectious disease, and this new collaboration will build upon that meaningful synergy."
June 28, 2022 - Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies of VBI's 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated the duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI's 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI's 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.
June 1, 2022 - VBI Vaccines Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency granted marketing authorization for PreHevbri™ for active immunization against infection caused by all known subtypes of HBV in adults.
May 9, 2022 - The Company confirmed PreHevbrio™ vaccine is available in the U.S. and is now approved in the European Union/European Economic Area as PreHevbri™.
May 2, 2022 - VBI Vaccines Inc. announced that the European Commission had granted Marketing Authorisation for PreHevbri™ for active immunization against infection caused by all known subtypes of HBV in adults.
March 29, 2022 - VBI Vaccines Inc. announced that PreHevbrio™ is now available in the U.S. at a Wholesale Acquisition Cost (WAC) set at $64.75/dose.
February 25, 2022 - VBI announced that the European Medicines Agency's vaccine committee adopted a positive opinion for VBI's 3-antigen hepatitis B vaccine, under the brand name PreHevbri™, for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.
February 23, 2022 - VBI announced that, following a discussion at this afternoon's U.S. CDC Advisory Committee meeting on Immunization Practices, PreHevbrio joined the list of recommended products for prophylactic adult vaccination against HBV infection.
December 9, 2021 - VBI Vaccines Inc. filed a New Drug Submission to Health Canada for the Company's PreHevbrio hepatitis B vaccine candidate, seeking approval in Canada to prevent infection caused by all known subtypes of the hepatitis B virus in adults.
December 1, 2021 - VBI announced that the U.S. FDA had approved PreHevbrio™ to prevent infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.
November 1, 2021 - VBI Vaccines Inc. announced that its abstract highlighting data from PROTECT, the pivotal Phase 3 immunogenicity and safety study of its 3-antigen prophylactic hepatitis B vaccine, was accepted for e-poster presentation (#706) at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®, to be held November 12-15, 2021.
October 13, 2021 - VBI Vaccines Inc. announced that results from the pivotal Phase 3 study, CONSTANT, of VBI's prophylactic 3-antigen HBV vaccine candidate in adults aged 18-45 were published in The Journal of the American Medical Association Network Open on Oct. 12, 2021. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI's 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.
August 2, 2021 - VBI Vaccines Inc.'s financial results for the second quarter ended June 30, 2021, and a corporate update was provided. FDA and EMA regulatory review of VBI's 3-antigen prophylactic HBV vaccine candidate ongoing – U.S. PDUFA target action date November 30, 2021.
July 1, 2021 - VBI Vaccines Inc. reported that the American Medical Association Current Procedural Terminology Panel had established a unique CPT code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine. If approved, VBI's 3-antigen HBV vaccine candidate will be reported using the new code, differentiating it from other single-antigen HBV vaccines.
February 2, 2021 - VBI Vaccines Inc. announced that the U.S. FDA accepted its filing of the Biologics License Application for the Company's 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The FDA has set a Prescription Drug User Fee Act target action date of November 30, 2021. The BLA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – and other relevant data. Additionally, in the filing notification letter, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
January 15, 2021 - VBI Vaccines Inc. announced that results from a Phase 4 study of VBI's prophylactic 3-antigen Hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier. The study was designed to evaluate VBI's 3-antigen HBV vaccine's immunogenicity in support of that batch's qualification as a new reference standard for vaccine release to the Israeli market, where VBI's Vaccine is available as Sci-B-Vac®.
January 13, 2021 - Study: Results from a Phase IV study: Rapid and high seroprotection rates achieved with a tri-antigenic Hepatitis B vaccine in healthy young adults. Highlights; Peak immune response was achieved one month after the third vaccination; TAV may enhance immunogenicity in adults with typically poor or delayed response to second-generation vaccines.
December 7, 2020 - VBI Vaccines Inc. and Syneos Health announced a partnership to commercialize VBI's 3-antigen prophylactic hepatitis B (HBV) vaccine in the United States, Europe, and Canada, pending regulatory approvals.
December 1, 2020 - VBI Vaccines Inc. announced the submission of a Biologics License Application to the U.S. FDA seeking approval of the Company's 3-antigen prophylactic hepatitis B vaccine candidate prevention infection caused by all known subtypes of the hepatitis B virus in adults.
November 23, 2020 - VBI Vaccines Inc. submitted a Marketing Authorization Application to the European Medicines Agency for the Company's 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval to prevent infection caused by all known subtypes of the hepatitis B virus in adults.
November 13, 2020 - VBI announced the presentation of its abstract featuring data from one of the pivotal Phase 3 studies (PROTECT) evaluating Sci-B-Vac®, the Company's 3-antigen prophylactic hepatitis B vaccine, in an e-poster presentation at the American Association for the Study of Liver Diseases – The Liver Meeting.
October 26, 2020 - VBI Vaccines announced the presentation of two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the Company's 3-antigen prophylactic hepatitis B (HBV) Vaccine, in e-poster presentations at ID Week 2020. Across the PROTECT and CONSTANT registrational Phase 3 studies, Sci-B-Vac safely elicited higher anti-HBs titers in all study subjects than Engerix-B, a single antigen HBV vaccine, regardless of age, gender, or underlying comorbidity.
August 31, 2020 - VBI Vaccines Inc. announced the presentation of abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the Company's tri-antigenic prophylactic hepatitis B (HBV) Vaccine, in a late-breaker oral presentation and a poster presentation, which took place on August 27-29, 2020.
January 9, 2020 - VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints; op-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®, the Company's trivalent hepatitis B (HBV) vaccine, and comparing safety and immunogenicity of Sci-B-Vac® to GlaxoSmithKline's currently-marketed HBV vaccine, Engerix-B®. The Phase 3 study, which enrolled 2,838 adults aged 18-45, met primary and secondary endpoints.
October 16, 2018 - VBI Vaccines Completes Vaccination in PROTECT Phase 3 Clinical Study for Sci-B-Vac® Hepatitis B Vaccine.
December 2017 - VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the Company to seek marketing authorization in the U.S., Europe, and Canada.
Sci-B-Vac Vaccine Clinical Trials
Sci-B-Vac Vaccine has been tested in several clinical trials and a Phase 4 post-marketing clinical trial.