 Attention Immunization Partners,
Please share this widely with all immunizing providers, staff, and colleagues.
The Michigan Department of Health and Human Services (MDHHS) Division of Immunization is notifying all immunization providers to immediately stop using the hepatitis B vaccine PreHevbrio®.
The vaccine manufacturer, VBI Vaccines Inc. (VBI), is initiating a voluntary nationwide recall of all remaining PreHevbrio® [Hepatitis B Vaccine (Recombinant); Adult; SDV; 10-pack: NDCs 75052-001-01, and 75052-001-10] (“PreHevbrio®”) due to the bankruptcy of the company and termination of operations. Distribution or use of any remaining PreHevbrio® vaccine by healthcare providers or others must cease immediately. The U.S. Food and Drug Administration (FDA) is aware that VBI Vaccines has permanently discontinued PreHevbrio®.
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.
Providers enrolled in the Vaccines For Children/Adult Vaccine Program with MDHHS: When noting the reason in the vaccine inventory module within the Michigan Care Improvement Registry (MCIR) please note the return with the reason “recall”.
Clinical Guidance:
- Doses already administered are valid.
- The Centers for Disease Control and Prevention (CDC) Division of Viral Hepatitis is working to develop guidance about what to do for patients who have started but not completed the series with PreHevbrio®. Hepatitis B Vaccine Administration | Hepatitis B | CDC
Additional Questions:
Healthcare providers and distributors with questions regarding this recall can contact VBI Vaccines at prehevbrio@vbivaccines.com.
Sources:
MDHHS will continue to share updates with our immunization partners as we receive them.
Thank you,
Oakland County Health Division, Immunization Action Plan
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