Supply Updates Announced for Recombivax HB Vaccines

Merck has provided several updates regarding supply issues surrounding its hepatitis B vaccine, Recombivax HB (hepatitis B surface antigen vaccine [recombinant]; Merck).

The information, posted to the Food and Drug Administration (FDA) website, states that both the Recombivax HB adult (10mcg/mL) and dialysis (40mcg/mL) formulations are not expected to be available in 2019. Recombivax HB is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus. It is approved for use in individuals of all ages. Recombivax HB Dialysis Formulation is approved for use in predialysis and dialysis patients 18 years of age and older.

As for the pediatric/adolescent formulation (5mcg/0.5mL), the Company states that the vaccine will not be distributed through the second quarter of 2019. To address the gap in pediatric hepatitis B vaccine supply, GlaxoSmithKline will increase production of both single-component vaccine (Engerix-B) and combination vaccine (Pediarix). Guidance for completing the hepatitis B series during the Recombivax HB shortage can be found here.

For more information visit FDA.gov.