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VBI Vaccines Issues Voluntary Nationwide Recall of All PreHevbrio® Vaccine Within Expiry Due to Discontinuation of Company Operations

VBI Vaccines is initiating a voluntary nationwide recall of all remaining PreHevbrio® [Hepatitis B Vaccine (Recombinant); NDC 75052-001-10] (“PreHevbrio”) due to the bankruptcy of the company and termination of operations.

Further distribution or use of any remaining PreHevbrio vaccine by healthcare providers or others must cease immediately.

VBI Vaccines Inc. and its affiliates commenced a proceeding under Canada’s Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the “CCAA Proceeding”) on July 29, 2024, in the Superior Court of Justice (Commercial List) in Ontario, Canada.  VBI Vaccines (Delaware) Inc. and certain other affiliates filed petitions and a motion under chapter 15 of the Bankruptcy Code for recognition of the Canadian Proceeding as a foreign main proceeding on July 30, 2024, in the United States Bankruptcy Court for the District of Delaware (together with the CCAA Proceeding, the “Restructuring Proceedings”). In connection with the Restructuring Proceedings, on October 25, 2024, the company issued an initial communication to healthcare providers and the FDA regarding its intent to voluntarily withdraw PreHevbrio from the U.S. market. The company is rapidly winding down all U.S. operations and has permanently ceased distribution of PreHevbrio, a vaccine indicated for the prevention of infection caused by hepatitis B virus in adults.

PreHevbrio was distributed nationwide to distributors and healthcare providers.

COMMUNICATION AND REQUEST FOR DESTRUCTION OF INVENTORY:

VBI Vaccines is notifying its distributors, clients, and healthcare providers by direct mail and is requesting that they further notify or re-notify any potentially affected customers, consumers, and/or patients of this recall. VBI Vaccines is requesting immediate destruction of all existing vials of PreHevbrio in accordance with applicable law, and notification of product disposition to prehevbrio@vbivaccines.com.

The U.S. Food and Drug Administration is aware that VBI Vaccines has permanently discontinued distribution of PreHevbrio.

ADVERSE EVENT REPORTING:

Adverse reactions or possible side effects experienced in connection with the use of PreHevbrio may be reported to Vaccine Adverse Event Reporting System (“VAERS”) either online, by fax, or by regular mail.

VAERS
P.O. Box 1100
Rockville, MD, 20849-1100

If you require assistance with reporting, you can contact VAERS by email at info@vaers.org or by phone at 1-800-822-7967.

INTERCHANGEABILITY AND SERIES COMPLETION:

For healthcare providers needing to complete a Hepatitis B vaccination series when the original vaccine administered is no longer available, please refer to the Centers for Disease Control and Prevention (CDC) Hepatitis B vaccination guidelines at https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/.

HOW TO IDENTIFY PREHEVBRIO:

Name NDC Numbers Label & Additional Information
PreHevbrio NDC 75052-001-01, 75052-001-10 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36e9a878-d6c2-4808-9915-294f47b1fe3d

PreHevbrio Lots & Expiration Dates:

Lot Code Expiry Date
B2201V1 3/31/2025
B2211V1 4/30/2025
B2321V1A 2/28/2026
B2281V1 12/31/2025
B2461V1A 12/31/2026
B2451V1B 11/30/2026
B2251V1 9/30/2025

Carton and Vial Photo:

HOW TO IDENTIFY PREHEVBRIO:

PreHevbrio Lots & Expiration Dates:

Lot Code Expiry Date
B2201V1 3/31/2025
B2211V1 4/30/2025
B2321V1A 2/28/2026
B2281V1 12/31/2025
B2461V1A 12/31/2026
B2451V1B 11/30/2026
B2251V1 9/30/2025

Carton and Vial Photo:

ADDITIONAL QUESTIONS:

Healthcare providers and distributors with questions regarding this recall can contact VBI Vaccines at prehevbrio@vbivaccines.com. Consumers who received PreHevbrio should reach out to their physicians or other qualified healthcare providers with any questions or concerns related to the use of PreHevbrio.

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Indication & Important Safety Info
INDICATION

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

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.

INDICATION

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

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 medinfo@vbivaccines.com or call 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.

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ENROLLMENT2

Demographic and baseline characteristics were similar in both vaccine groups.

CONSTANT STUDY DESIGN3

STUDY OBJECTIVES

The primary objective was to demonstrate consistency of immune response as measured by geometric mean concentration of antibodies across three consecutively manufactured lots of PreHevbrio 10 μg. The secondary objective was to demonstrate non-inferiority of SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) of PreHevbrio (pooled) compared to Engerix-B at Day 196.

ENROLLMENT3

Demographic and baseline characteristics were similar in both vaccine groups.

PROTECT STUDY DESIGN3

STUDY OBJECTIVES

The two co-primary objectives of comparing SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) at 4 weeks after receiving the third dose of PreHevbrio or Engerix-B were non-inferiority in adults ≥18 years of age and superiority in adults ≥45 years of age for PreHevbrio 10 μg compared to Engerix-B 20 μg. Key secondary endpoints included SPRs for PreHevbrio at days 56 and 168 and for Engerix-B at day 196; local and systemic solicited adverse events; and unsolicited adverse events. Key exploratory endpoints included SPRs for both study groups at days 0, 28, 56, 168, and 336; geometric mean concentration of anti-HBs antibody titers; and the proportion of participants having anti-HBs titers ≥100 mIU/mL at days 28, 56, 168, 196, and 336.