CAMBRIDGE, Mass.--(BUSINESS WIRE)--VBI Vaccines Inc. (VBI) 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.

马萨诸塞州剑桥市。-（商业新闻短讯）--VBI疫苗公司（VBI）正在全国范围内自愿召回所有剩余的PreHevbrio®[乙型肝炎疫苗（重组）；NDC 75052-001-10]（“PreHevbrio”），原因是该公司破产并终止运营。

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

医疗保健提供者或其他人必须立即停止进一步分发或使用任何剩余的PreHevbrio疫苗。

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”).

VBI疫苗公司及其附属公司于2024年7月29日在加拿大安大略省高等法院（商业清单）根据加拿大《公司债权人安排法》（R.s.C.1985，C.C-36）及其修订案（“CCAA程序”）提起诉讼。2024年7月30日，VBI Vaccines（Delaware）Inc.和某些其他附属公司根据《破产法》第15章向美国特拉华州破产法院提交了申请和动议，以承认加拿大程序为外国主要程序（连同CCAA程序，简称“重组程序”）。

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..

关于重组程序，2024年10月25日，该公司向医疗保健提供者和FDA发布了一份初步通信，内容涉及其自愿从美国市场撤回PreHevbrio的意图。该公司正在迅速关闭所有美国业务，并已永久停止分发PreHevbrio，这是一种用于预防成人乙型肝炎病毒感染的疫苗。。

PreHevbrio vaccine was distributed nationwide to distributors and healthcare providers.

PreHevbrio疫苗已在全国范围内分发给分销商和医疗保健提供者。

COMMUNICATION AND REQUEST FOR DESTRUCTION OF INVENTORY:

通信和销毁库存的请求：

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..

VBI疫苗通过直邮通知其分销商、客户和医疗保健提供者，并要求他们进一步通知或重新通知任何可能受影响的客户、消费者和/或患者此次召回。VBI疫苗要求根据适用法律立即销毁所有现有的PreHevbrio小瓶，并将产品处置通知prehevbrio@vbivaccines.com..

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

美国食品和药物管理局知道VBI已永久停止分发PreHevbrio。

ADVERSE EVENT REPORTING:

不良事件报告：

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.

与使用PreHevbrio有关的不良反应或可能的副作用可能会通过在线，传真或定期邮件报告给疫苗不良事件报告系统（“VAERS”）。

Complete and submit the report Online: https://vaers.hhs.gov/

在线填写并提交报告：https://vaers.hhs.gov/

Regular Mail or Fax: Download PDF form (https://vaers.hhs.gov/) and fax to 1-877-721-0366, or mail the completed form to:

普通邮件或传真：下载PDF格式(https://vaers.hhs.gov/)并传真至1-877-721-0366，或将填写好的表格邮寄至：

VAERS

阀门

P.O. Box 1100

P、 邮政信箱1100

Rockville, MD, 20849-1100

马里兰州罗克维尔，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.

如果您需要报告方面的帮助，可以通过电子邮件联系VAERSinfo@vaers.org或致电1-800-822-7967。

INTERCHANGEABILITY AND SERIES COMPLETION:

互换性和系列完成：

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 (CDC) Hepatitis B vaccination guidelines at https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/.

对于不再提供原始疫苗时需要完成乙型肝炎疫苗接种系列的医疗保健提供者，请参阅疾病控制中心（CDC）乙型肝炎疫苗接种指南https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/.

HOW TO IDENTIFY PREHEVBRIO:

Please visit www.prehevbrio.com for vial and carton labels as well as information about unexpired lots of PreHevbrio.

请访问www.prehevbrio.com获取小瓶和纸箱标签以及未过期的prehevbrio批次信息。

ADDITIONAL QUESTIONS:

其他问题：

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..

医疗保健提供者和分销商如对此次召回有疑问，请联系VBI疫苗prehevbrio@vbivaccines.com.接受PreHevbrio的消费者应向其医生或其他合格的医疗保健提供者咨询与使用PreHevbrio有关的任何问题或担忧。。