FDA expanded the approval of Shingrix, an adjuvanted recombinant zoster vaccine, for adults at increased risk of shingles due to immunosuppression, manufacturer GlaxoSmithKline (GSK) on Monday.
The expanded indication is for adults ages 18 and older at a greater risk of shingles due to "immunodeficiency or immunosuppression caused by known disease or therapy." The most common risk factors for shingles are older age and being immunocompromised, according to GSK.
Shingrix in 2017 for adults ages 50 and older, and in 2018 received a preferential recommendation by the CDC's Advisory Committee on Immunization Practices (ACIP) over live vaccine, Zostavax. ACIP is currently discussing recommending Shingrix for immunocompromised adults, as well, GSK noted.
Shingrix is a two-dose intramuscular vaccine, where the second dose is administered 2 to 6 months later. However, GSK said adults who "are or will be immunodeficient or immunosuppressed due to known disease or therapy" or who would benefit from a shorter vaccination schedule can have the second dose as early as 1 month after the first dose.
Primary support for the expanded indication came from a phase III randomized trial of adults who had undergone autologous hematopoietic stem cell transplant, . Participants received a transplant 50 to 70 days prior to dose 1 of the vaccine and were expected to receive antiviral therapy for an additional 6 months afterwards. Overall vaccine efficacy was 68.2% (95% CI 55.5-77.6), defined as those who did not develop herpes zoster within 1 month after the second dose.
A post-hoc analysis of adults with hematologic malignancies showed 87.2% vaccine effectiveness (95% CI 44.2-98.6), with GSK noting additional safety and immunogenicity data from patients with HIV, solid tumors, and renal transplants.
The FDA label noted safety data from six studies of immunocompromised participants. Pain, fatigue, myalgia, and headache were common among this group. New-onset potential immune-related diseases and other medically relevant events, including relapse or progression, were comparable between vaccine and placebo groups.
Shingrix is contraindicated for immunocompromised adults with a history of severe allergies, anaphylaxis, or those with prior vaccine-related adverse reactions, according to the vaccine's label.
GSK added that the vaccine is not approved for preventing chickenpox (primary varicella), and that pregnancy and lactation data are lacking.
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Primary Source
FDA Release