At a recent meeting, an important question was raised during a meeting of the Advisory Committee on Immunization Practices (ACIP).

The group that advises the CDC asked, "Should adults ³19 years of age who are or will be immunodeficient or immunosuppressed due to disease or therapy be recommended to receive two doses of recombinant zoster vaccine for the prevention of herpes zoster and its complications?"

The ACIP said that those conditions included but were not limited to:

• Hematopoietic stem cell transplant (HSCT) recipients

• Hematologic malignancies

• Renal or other solid organ transplants

• Solid tumor malignancies

• HIV  

• Primary immunodeficiencies, autoimmune conditions, and use of immunosuppressive medications/therapies

The result of the discussion was a unanimous recommendation for two doses of zoster vaccine recombinant adjuvanted, marketed as Shingrix, for the prevention of shingles (herpes zoster) and its complications in adults aged 19 years and older who are or will be immunodeficient or immunosuppressed due to disease or therapy.

"Today's recommendation is an important clinical advancement in providing protection from shingles and its complications to adults with immunodeficiency or immunosuppression," said Sabine Luik, chief medical officer & SVP Global Medical Regulatory & Quality, GlaxoSmithKline plc. "The ACIP's vote helps to address an existing unmet need as individuals who are immunocompromised are at an increased risk of the disease.

In July, the FDA approved Shingrix (for the prevention of shingles [herpes zoster] in adults aged 18 years and older who are or who will be at increased risk for shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. The FDA noted that immunocompromised persons are at greater risk for shingles and associated complications than immunocompetent individuals.

In a recent press release, GSK points out that the approval and ACIP recommendations for a new population were based on clinical studies examining the safety and efficacy of Shingrix in adults (age >18 years) who had undergone an autologous HSCT and those undergoing treatment for hematological malignancies (post hoc analysis). GSK adds, "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, including patients with HIV, solid tumors, and renal transplants."

Shingrix, which is not indicated for prevention of primary varicella infection (chickenpox), combines a nonlive antigen to trigger an immune response targeted to the varicella zoster virus.

GSK advises that, for immunocompetent adults, Shingrix is intended to be administered in two doses, 2 to 6 months apart. The second dose may be administered 1 to 2 months after the first dose, however, 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 ACIP recommendations have been forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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