CDC Recommends GSK’s Shingrix for Immunocompromised Adults Aged 19 and Older
Oct 29, 2021 11:44
CST Updated
11:44
GSK
Pharmaceutical R&D Manufacturer
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is an agency under the U.S. Department of Health and Human Services, with its headquarters located in Atlanta, Georgia. As a federal government administrative agency, the CDC provides reliable information to protect public health and safety. Through strong partnerships with national health departments and other organizations, it aims to enhance health-related decision-making and promote the well-being of citizens.
Herpes zoster (herpes zoster; Image source: medicalnewstoday.com)
October 28, 2021 /BioonBIOON/ --GlaxoSmithKline(GSK) recently announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend:2 doses of Shingrix (recombinant zoster vaccine; Chinese trade name: Xinganlishi), indicated for the prevention of herpes zoster and its complications in adults aged 19 years and older who are immunocompromised. Specifically: adults aged 19 years and older who are or will be immunodeficient or immunosuppressed due to disease or therapy.
This vote means that in the United States, millions of adults aged 19 years and older who are at increased risk of herpes zoster due to immunodeficiency or immunosuppression are now recommended to receive the Shingrix vaccine.
Sabine Luik, Chief Medical Officer and Senior Vice President of GSK's Global Medical Affairs and Quality, said: "Today's recommendation represents a significant clinical advance in protecting immunodeficient or immunosuppressed adults against herpes zoster and its complications. The ACIP vote helps address an existing unmet need, as immunocompromised individuals are at an increased risk of developing herpes zoster disease."
This approval and recommendation for the new patient population is based on patients receiving autologous hematopoieticStem CellsTransplantation (auHSCT) and Hematologic MalignanciesTumorClinical study data (post-hoc analysis) evaluating the safety and efficacy of Shingrix conducted in adult patients (aged ≥18 years). Additional safety and immunogenicity data were generated from adult populations with known diseases or treatments that cause or are expected to cause immunodeficiency or immunosuppression, including patients with HIV, solid tumors, and kidney transplant recipients.
Regarding vaccination,For immunocompetent adults, Shingrix is administered as a 2-dose series with an interval of 2 to 6 months between doses. However, for adults who are or will be immunodeficient or immunosuppressed due to a known disease or therapy, and for adults who would benefit from a shorter dosing interval, the second dose may be administered 1 to 2 months after the first dose.
ACIP recommendations will be submitted to the CDC Director and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a forthcoming issue of the Morbidity and Mortality Weekly Report (MMWR).
Shingrix is a recombinant subunit adjuvanted vaccine that combines varicella-zoster virus glycoprotein E (gE) with the proprietary adjuvant system AS01B, capable of eliciting a strong and sustained immune response.
Shingrix was approved by the U.S. FDA in 2017 for the prevention of herpes zoster in adults aged 50 years and older. In July 2021, the U.S.FDAApproval of Shingrix for an Expanded Indication: for the prevention of herpes zoster in immunocompromised adults aged 18 years and older. Specifically, the vaccine is indicated for: adults aged 18 years and older who are at increased or potentially increased risk of herpes zoster due to immunodeficiency or immunosuppression resulting from a known disease or therapy. In the European Union, Shingrix was approved in August 2020 for the prevention of herpes zoster and postherpetic neuralgia (PHN) in adults aged 18 years or older at increased risk of herpes zoster.
Shingrix is not indicated for the prevention of primary varicella infection. This approval for individuals aged 18 years and older who are immunocompromised expands the eligible population for herpes zoster prevention with Shingrix.
It is worth noting that,Shingrix is the first herpes zoster vaccine approved for use in immunocompromised individuals. Immunocompromised individuals are at a higher risk of developing herpes zoster and related complications compared to immunocompetent individuals.。
In China, Shingrix (Xinanlishi) was approved in June 2020 for the prevention of herpes zoster in adults aged 50 years and older. Notably, Shingrix is among the first batch of 48 overseas-marketed "new drugs urgently needed for clinical use" rapidly introduced by national authorities, and it is also the first recombinant zoster vaccine currently marketed in China. It has effectively filled a gap in the field of herpes zoster prevention in China, further expanding China's vaccine-preventable disease system. (Bioon.com)