PREHEVBRIO

FDA is informing healthcare providers and vaccine recipients that PreHevbrio (Hepatitis B Vaccine, Recombinant) has been voluntarily withdrawn from the market by the company, VBI Vaccines Inc., due to the bankruptcy of the company and the termination of its operations. The market withdrawal of PreHevbrio by VBI Vaccines Inc. is not due to safety or effectiveness concerns with the vaccine.

Because of the company’s discontinuation of operations, any remaining PreHevbrio should not be used or further distributed, and any existing vials of vaccine should be destroyed immediately in accordance with applicable law. The company has requested notification of vaccine disposition to prehevbrio@vbivaccines.com. For those who have initiated the three-dose series of PreHevbrio, but have not completed the series, please refer to the CDC recommendations for guidance on completing the series.

Potential adverse reactions or possible side effects experienced with the use of PreHevbrio may be reported to the Vaccine Adverse Event Reporting System (VAERS).

STN: 125737
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: PREHEVBRIO
Manufacturer: VBI Vaccines (Delaware) Inc.
Indication:

For prevention of infection caused by all known subtypes of the hepatitis B virus in adults 18 years and older.

Product Information

Package Insert - PREHEVBRIO
Demographic Subgroup Information – Hepatitis B Vaccine (Recombinant) - PREHEVBRIO
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents