FDA Approves Expansion of Shingrix for Prevention of Herpes Zoster in Immunocompromised Adults

Zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline) has been approved by the FDA for the prevention of herpes zoster in adults 18 years of age and older who are, or will be, at an increased risk of shingles because of immunodeficiency or immunosuppression. Such an immunocompromised state can occur due to known disease or therapy, leading to individuals in this state being at an increased risk of herpes zoster and associated complications.

A non-live sub-unit vaccine, zoster vaccine recombinant, adjuvanted was previously approved by the FDA in 2017 for the prevention of herpes zoster in adults 50 years of age or older. However, the vaccine is not indicated for the prevention of primary varicella infection, or chickenpox.

Administered intramuscularly in 2 separate doses, the vaccine was previously approved to be administered 2 to 6 months apart among immunocompetent adults. For 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 FDA approved the administration of the second dose in this patient population 1 to 2 months after the first dose.

Additionally, by expanding the population who can be protected against herpes zoster with the vaccine to those who are immunodeficient or immunosuppressed, this approval expansion makes zoster vaccine recombinant, adjuvanted the first vaccine for use in this patient population.

“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, in a press release. “Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition.”

During clinical studies examining the safety and efficacy of zoster vaccine recombinant, adjuvanted in adults 18 years of age or older, the study investigators evaluated the benefit-risk profile of the vaccine in heterogeneous immunocompromised patient populations who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and in those undergoing treatment for hematological malignancies in a post-hoc analysis.

Additionally, further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, such as for patients with HIV, solid tumors, and renal transplants.

“In addition to this new patient population, there are more than 100 million adults 50 years and older in the US already recommended to receive Shingrix,” Breuer said in the press release. “We know many of these individuals missed recommended vaccines during the pandemic and we hope this can be a reminder to them to catch up on all their immunizations, including Shingrix.”

A recent report from Avalere Health found that in total, 17 million doses of recommended vaccines, including zoster vaccine recombinant, adjuvanted, were missed by adults during the pandemic. In light of this increased need for protection against disease among the US population as COVID-19 persists throughout the country, ongoing vaccinations among eligible US adults remains critical.

REFERENCE

Shingrix approved in the US for prevention of shingles in immunocompromised adults. Philadelphia, PA: GlaxoSmithKline; July 26, 2021. https://us.gsk.com/en-us/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/. Accessed July 26, 2021.