The Food and Drug Administration (FDA) has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of herpes zoster (shingles) in adults 18 years of age and older who are or who will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy. Previously, the vaccine was only approved for adults 50 years of age and older.
The approval was based on data from clinical studies that assessed the efficacy and safety of Shingrix in adults 18 years of age and older who previously had an autologous hematopoietic stem cell transplant (auHSCT; N=1721) and in those undergoing treatment for hematologic malignancies (N=515; post-hoc analysis).
Shingrix was found to be 68.2% (95% CI, 55.5-77.6) effective against the development of herpes zoster in immunocompromised adults who received an auHSCT 50 to 70 days prior to the first dose and who were expected to receive prophylactic antiviral therapy for at most 6 months post-transplant. In the hematologic malignancy study, post hoc analysis showed Shingrix was 87.2% (95% CI, 44.2-98.6) effective against herpes zoster development.
The approval was further supported by safety and immunogenicity data in adults who were, or were anticipated to be immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.
Shingrix is supplied as 2 components: a single-dose vial of lyophilized gE antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid). The recombinant subunit vaccine is intended for intramuscular injection in 2 doses separated by 2 to 6 months.
In adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose may be administered 1 to 2 months after the first dose.
“We’re proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease,” said Thomas Breuer, Chief Medical Officer, GSK Vaccines.
- Shingrix approved in the US for prevention of shingles in immunocompromised adults. News release. GlaxoSmithKline. Accessed July 26, 2021. https://us.gsk.com/en-us/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/.
- Shingrix [package insert]. Triangle Park, NC: GlaxoSmithKline. 2021.