The US Food and Drug Administration (FDA) has approved Shingrix (Zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older, who are, or who will be at an increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immuno-compromised individuals are at greater risk of shingles and associated complications than immuno-competent individuals, the company said in a statement.
It also said that Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix.
“We’re proud to offer Shingrix in the US 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,” said Thomas Breuer, Chief Medical Officer, GSK Vaccines.
He also said, “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 GSK Clinical Development Program evaluated the benefit-risk profile of Shingrix in heterogeneous immuno-compromised patient populations, added the statement.
It also said that the approval 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 tumours and renal transplants.
“In addition to this new patient population, there are more than 100 million adults aged 50 years and older in the US already recommended to receive Shingrix,” said Breuer.
He added, “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 immunisations, including Shingrix.”
According to a recently published report from Avalere Health and supported by GSK, over 17 million doses of recommended vaccines, including Shingrix, were missed by adults during the pandemic, mentioned the statement.