By NewsDesk @bactiman63
GlaxoSmithKline announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) and its complications in adults 19 years of age and older who are or will be immunodeficient or immunosuppressed due to disease or therapy.
The vote means that millions of adults in the US aged 19 years and older who are at increased risk of shingles due to immunodeficiency or immunosuppression are now recommended to receive Shingrix.
“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, GSK. “The ACIP’s vote helps to address an existing unmet need as individuals who are immunocompromised are at an increased risk of the disease.”
This approval and recommendation for a new population was based on clinical studies examining the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies (post-hoc analysis). 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 combines a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant system to generate a Varicella Zoster Virus (VZV)-specific immune response. Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
For immunocompetent adults, Shingrix is intended to be administered in two doses, 2 to 6 months apart. However, 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 second dose can be administered 1 to 2 months after the first dose.
The ACIP recommendations will be forwarded to the director of the CDC and the US 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 (MMWR).