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FDA approved GlaxoSmithKline Shingrix: The first shingles vaccine for immunocompromised adults!
FDA approved GlaxoSmithKline Shingrix: The first shingles vaccine. GlaxoSmithKline (GSK) recently announced that the U.S. Food and Drug Administration (FDA) has approved Shingrix (recombinant shingles vaccine, for immunocompromised 18 years and older. Prevent shingles in adults.
The vaccine is specifically applicable to adults aged 18 and over who are at or will have an increased risk of shingles due to immunodeficiency, or immunosuppression caused by known diseases or treatments.
In the European Union, Shingrix was approved in August 2020 for use in adults 18 years of age or older at an increased risk of shingles to prevent shingles and post-herpetic neuralgia (PHN).
Shingrix is a recombinant subunit adjuvant vaccine that is injected intramuscularly in two doses. This product was approved by the US FDA in 2017 for the prevention of shingles in adults aged 50 and above. Shingrix is not suitable for the prevention of primary varicella infection. The approval for immune-compromised people aged 18 years and older expands the number of people who can prevent shingles through Shingrix.
It is worth mentioning that Shingrix is the first shingles vaccine approved for immunocompromised people. Individuals with low immune function are at greater risk of developing shingles and related complications than individuals with normal immune function. In terms of vaccination, Shingrix is divided into 2 doses for adults with normal immune function, with an interval of 2-6 months. However, for immunocompromised adults and adults who will benefit from a shorter vaccination regimen, the second dose can be given within 1-2 months after the first dose.
In China, Shingrix was approved in June 2020 for the prevention of shingles in adults aged 50 and above. It is worth mentioning that Shingrix is one of the country’s first batch of 48 “clinically urgently needed new drugs” that have been marketed overseas quickly introduced by the country, and it is also the first domestically marketed recombinant shingles vaccine, which effectively fills in the prevention of herpes zoster disease in China. The gap in the field has further expanded some countries’s vaccine prevention system.
Thomas Breuer, Chief Medical Officer of GlaxoSmithKline Vaccines, said: “With the approval of this broad indication for the adult population at increased risk of shingles, we are honored to provide Shingrix in the United States for the prevention of zoster in the immune-compromised population. Herpes. Old age and low immune function are the most common risk factors for shingles. GlaxoSmithKline is committed to providing a vaccine option to prevent this important group of adult patients who are at increased risk of herpes zoster disease and its complications. This painful disease.”
The GlaxoSmithKline clinical development project evaluated the benefit and risk of Shingrix in a variety of immunocompromised patient populations.
The FDA’s approval of this new population is based on the safety and effectiveness of Shingrix vaccination for adults (=18 years old) receiving autologous hematopoietic stem cell transplantation (auHSCT) and adults (=18 years old) undergoing treatment for hematological malignancies Clinical research (post-mortem analysis). Further safety and immunogenicity data are generated in adult patients who are already in or are expected to be in an immunodeficiency or immunosuppressive state due to known diseases and treatments, including HIV, solid tumors and kidney transplant patients.
Thomas Breuer said: “In addition to this new patient population, more than 100 million adults aged 50 and over in the United States have been recommended to receive Shingrix vaccination. We know that many of these people missed out during the COVID-19 pandemic. With the recommended vaccine, we hope this will remind them to make up for all immunizations, including Shingrix.”
According to a report recently published by Avalere Health, in the adult population, more than 17 million doses of recommended vaccines, including Shingrix, were missed during the COVID-19 pandemic.
Shingrix is the first shingles vaccine suitable for people who are at increased risk of shingles infection due to immunodeficiency or immunosuppression due to disease or treatment. Shingrix combines a varicella-zoster virus glycoprotein E (gE) with the patented adjuvant system AS01B, which can produce a strong and long-lasting immune response. For adults with normal immune function, Shingrix is given in two doses, 2-6 months apart.
However, for adults who are or will lead to immunodeficiency or immunosuppression due to known diseases or treatments, and adults who will benefit from a shorter vaccination regimen, the second dose can be 1- Vaccination within 2 months.
The American Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization (ACIP) has begun discussing recommendations for the use of Shingrix in immunocompromised adults.
(source:internet, reference only)