VBI Vaccines Proclaims PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] Advisable by CDC Advisory Committee on Immunization Practices for the Prevention of Hepatitis B in Adults

Article content material

– PreHevbrio™ is the one authorized 3-antigen hepatitis B vaccine for adults within the U.S.

– Vaccine availability is predicted to start later in Q1 2022

CAMBRIDGE, Mass. — VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical firm pushed by immunology within the pursuit of highly effective prevention and remedy of illness, as we speak introduced that, following dialogue at this afternoon’s assembly of the Facilities for Illness Management and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] now joins the listing of advisable merchandise for prophylactic grownup vaccination in opposition to hepatitis B (HBV) an infection. This advice follows the approval of PreHevbrio by the U.S. Meals and Drug Administration (FDA) on November 30, 2021.

Article content material

“In the present day’s ACIP advice, in-line with our expectation, will considerably assist our efforts to offer broad entry to PreHevbrio as this achievement is a stage gate for reimbursement and protection,” mentioned Jeff Baxter, President and CEO. “Just lately, the ACIP has made significant adjustments within the suggestions and pointers for grownup HBV vaccination, notably with the transfer to a common advice for adults age 19-59. We echo the sentiment from as we speak’s presentation that the inclusion of PreHevbrio within the ACIP listing of advisable merchandise could possibly be a helpful adjunct in reaching HHS objectives of eliminating hepatitis B as a public well being risk within the U.S. by 2030. We look ahead to persevering with to assist the efforts of the CDC, the ACIP, and different public well being and advocacy companions on this endeavor.”

The inclusion of PreHevbrio within the ACIP suggestions can be mirrored in a future CDC publication and is a notable milestone as many insurance policy and establishments require an ACIP advice earlier than a vaccine is ready to be reimbursed or is made obtainable to sufferers. Moreover, PreHevbrio can be included within the subsequent annual replace of the ACIP Grownup Immunization Schedule in 2023, which is able to summarize adjustments that happen all through the approaching yr. VBI expects to commercially launch PreHevbrio within the U.S. by the top of the primary quarter of 2022. As soon as obtainable, PreHevbrio can be obtainable for buy by a community of distribution companions.

Indication and Use

PreHevbrio is indicated for prevention of an infection attributable to all recognized subtypes of hepatitis B virus. PreHevbrio is authorized to be used in adults 18 years of age and older.

Essential Security Data (ISI)

Don’t administer PreHevbrio to people with a historical past of extreme allergic response (e.g. anaphylaxis) after a earlier dose of any hepatitis B vaccine or to any element of PreHevbrio.

Applicable medical remedy and supervision should be obtainable to handle attainable anaphylactic reactions following administration of PreHevbrio.

Immunocompromised individuals, together with these on immunosuppressant remedy, might have a diminished immune response to PreHevbrio.

PreHevbrio might not stop hepatitis B an infection, which has a protracted incubation interval, in people who’ve an unrecognized hepatitis B an infection on the time of vaccine administration.

The commonest unintended effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ have been ache and tenderness on the injection web site, myalgia, fatigue, and headache.

Article content material

There’s a being pregnant publicity registry that displays being pregnant outcomes in girls who acquired PreHevbrio throughout being pregnant. Ladies who obtain PreHevbrio throughout being pregnant are inspired 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 Data.

About Hepatitis B

Hepatitis B is without doubt one of the world’s most important infectious illness threats with greater than 290 million folks contaminated globally. HBV an infection is the main reason for liver illness and, with present therapies, it is rather tough to remedy, with many sufferers occurring to develop liver cancers. An estimated 900,000 folks die annually from issues of continual HBV reminiscent of liver decompensation, cirrhosis, and hepatocellular carcinoma.

About PreHevbrio™

VBI’s vaccine candidate is the one 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 floor antigens of the hepatitis B virus, and is authorized to be used in the USA beneath the title PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and in Israel beneath the title Sci-B-Vac®. This vaccine candidate just isn’t but authorized in Canada or Europe, the place the regulatory submissions are nonetheless beneath assessment.

To be taught extra about VBI’s 3-Antigen Hepatitis B vaccine candidate go to: https://www.vbivaccines.com

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical firm pushed by immunology within the pursuit of highly effective prevention and remedy of illness. By way of its progressive strategy to virus-like particles (“VLPs”), together with a proprietary enveloped VLP (“eVLP”) platform expertise, VBI develops vaccine candidates that mimic the pure presentation of viruses, designed to elicit the innate energy of the human immune system. VBI is dedicated to focusing on and overcoming important infectious ailments, together with hepatitis B, coronaviruses, and cytomegalovirus (CMV), in addition to aggressive cancers together with glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with analysis operations in Ottawa, Canada, and a analysis and manufacturing web site in Rehovot, Israel.

Web site Residence: http://www.vbivaccines.com/
Information and Assets: http://www.vbivaccines.com/news-and-resources/
Buyers: http://www.vbivaccines.com/traders/

Article content material

Cautionary Assertion on Ahead-looking Data

Sure statements on this press launch which can be forward-looking and never statements of historic reality are forward-looking statements inside the which means of the secure harbor provisions of the Non-public Securities Litigation Reform Act of 1995 and are forward-looking info inside the which means of Canadian securities legal guidelines (collectively, “forward-looking statements”). The Firm cautions that such statements contain dangers and uncertainties that will materially have an effect on the Firm’s outcomes of operations. Such forward-looking statements are primarily based on the beliefs of administration in addition to assumptions made by and data at present obtainable to administration. Precise outcomes might differ materially from these contemplated by the forward-looking statements because of sure components, together with however not restricted to, the affect of common financial, trade or political situations in the USA or internationally; the affect of the continuing COVID-19 pandemic on our scientific research, manufacturing, marketing strategy, and the worldwide economic system; the power to efficiently manufacture and commercialize PreHevbrio; the power to determine that potential merchandise are efficacious or secure in preclinical or scientific trials; the power to determine or keep collaborations on the event of pipeline candidates and the commercialization of PreHevbrio; the power to acquire acceptable or needed regulatory approvals to market potential merchandise; the power to acquire future funding for developmental merchandise and dealing capital and to acquire such funding on commercially cheap phrases; the Firm’s potential to fabricate product candidates on a industrial scale or in collaborations with third events; adjustments within the dimension and nature of opponents; the power to retain key executives and scientists; and the power to safe and implement authorized rights associated to the Firm’s merchandise. A dialogue of those and different components, together with dangers and uncertainties with respect to the Firm, is ready forth within the Firm’s filings with the SEC and the Canadian securities authorities, together with its Annual Report on Type 10-Ok filed with the SEC on March 2, 2021, and filed with the Canadian safety authorities at sedar.com on March 2, 2021, as could also be supplemented or amended by the Firm’s Quarterly Studies on Type 10-Q. Given these dangers, uncertainties and components, you might be cautioned to not place undue reliance on such forward-looking statements, that are certified of their entirety by this cautionary assertion. All such forward-looking statements made herein are primarily based on our present expectations and we undertake no responsibility or obligation to replace or revise any forward-looking statements for any motive, besides as required by regulation.

View supply model on businesswire.com: https://www.businesswire.com/information/house/20220223006272/en/

Contacts

VBI Contact
Nicole Anderson
Director, Company Communications & IR
Cellphone: (617) 830-3031 x124
Electronic mail: IR@vbivaccines.com

#distro