The Advisory Committee on Immunization Practices (ACIP) of the American Centers for Disease Control and Prevention (CDC) voted unanimously to recommend 2 doses of the Shingrix vaccine * for the prevention of Herpes Zoster and its complications in adults aged 19 years and beyond who are or will be immunodeficient or immunosuppressed due to disease or treatment. GlaxoSmithKline announces it.
Shingrix, a non-live, recombinant adjuvanted Zoster vaccine administered intramuscularly in 2 doses – the company recalls – was initially approved by the American Drug Agency Fda in 2017 for the prevention of Herpes Zoster in adults aged 50 or older. more. The Food and Drug Administration therefore approved the vaccine last July for the prevention of Shingles in adults 18 years of age and older who are or will be at increased risk of Shingles due to immunodeficiency or immunosuppression caused by a disease. or known therapy. “Today’s recommendation is an important clinical advance in providing protection from Herpes Zoster and its complications to adults with immunodeficiency or immunosuppression,” said Sabine Luik, Chief Medical Officer & Svp Global Medical Regulatory & Quality, Gsk. helps address an existing unmet need, as immunocompromised individuals are at increased risk of the disease. “
ACIP’s recommendations – the British company explains in a note – will be forwarded to the director of the CDC and to the United States Department of Health and Human Services for review and approval. Once authorized, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (Mmwr).
This approval and recommendation for a new population was based on clinical studies that examined the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone autologous hematopoietic stem cell transplantation and in those being treated for malignant haematological tumors. Additional safety and immunogenicity data were generated in adults who were, or were expected to be, immunodeficient or immunosuppressed due to known diseases or therapies, including patients with HIV, solid tumors and kidney transplants.
Shingrix combines a non-live antigen, to trigger a targeted immune response, with an adjuvant system specifically designed to generate a Varicella Zoster virus-specific immune response. It is not indicated for the prevention of primary chickenpox infection, it is specified in the note.
For immunocompetent adults – it says – Shingrix is intended to be administered in 2 doses, 2-6 months apart. However, for adults who are or will be immunodeficient or immunosuppressed due to a known disease or therapy, and who would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the first dose.
#CDC #USA #green #light #Gsk #Herpes #Zoster #vaccine #immunocompromised #19s