FDA approves Shingrix for prevention of shingles in immunocompromised adults
The FDA this week approved Shingrix for the prevention of shingles in immunocompromised adults, GlaxoSmithKline announced.
Shingrix (recombinant zoster vaccine; RZV), is a nonlive, recombinant sub-unit adjuvanted vaccine that was initially approved by the FDA in 2017 for the prevention of shingles in adults aged 50 years or older.
The vaccine, which is administered intramuscularly in two doses, is now approved for adults aged 18 years or older who are or will be at an increased risk for shingles because of immunodeficiency or immunosuppression caused by known disease or therapy, GlaxoSmithKline said.
“We’re proud to offer Shingrix in the United States for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease,” Thomas Breuer, MD, MSc, the chief medical officer for GlaxoSmithKline vaccines, said in a press release. “Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition.”
The approval is based on positive data from clinical trials that examined the safety and efficacy of RZV among adults who had undergone an autologous hematopoietic stem cell transplant or were undergoing treatment for hematological malignancies. Additionally, further safety and immunogenicity data were generated in adults who were — or were anticipated to be — immunodeficient or immunosuppressed because of known disease or therapy, including patients with HIV, solid tumors and renal transplants.
“In addition to this new patient population, there are more than 100 million adults 50 years and older in the U.S. already recommended to receive Shingrix,” Breuer said. “We know many of these individuals missed recommended vaccines during the pandemic and we hope this can be a reminder to them to catch up on all their immunizations, including Shingrix.”
GSK. Shingrix approved in the US for prevention of shingles in immunocompromised adults. https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/. Accessed on July 29, 2021.