GlaxoSmithKline (GSK) has received the US Food and Drug Administration (FDA) approval for Shingrix (Zoster vaccine recombinant, adjuvanted) to prevent shingles (herpes zoster).
The vaccine is indicated for use in adults aged 18 years and older, at high risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.
Shingrix is a non-live, recombinant sub-unit adjuvanted vaccine, administered intramuscularly in two doses.
It is designed by combining a non-live antigen with a specifically designed adjuvant system to generate a VZV-specific immune response.
Shingrix was initially approved by the US FDA in 2017, for the prevention of shingles in adults aged 50 years and above.
In August last year, Shingrix was granted marketing authorisation in Europe to prevent shingles and post-herpetic neuralgia (PHN) in adults aged 18 years and above.
The current approval expands the Shingrix indication for new age-group, allowing more people to get protection against shingles through access to the vaccine.
GSK claimed that Shingrix is the first vaccine for people at high risk of shingles, due to their immunodeficiency or immunosuppressed due to disease or therapy.
GSK vaccines chief medical officer Thomas Breuer said: “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.
“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.”
Shingles disease is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox and is characterised by a painful, itchy rash on one side of the body.
The clinical development programme at the company evaluated the benefit-risk profile of Shingrix in heterogeneous immunocompromised patient populations.
According to the company, immunocompromised individuals are at increased risk of shingles and their related complications compared to immunocompetent individuals.
The FDA approval for the new age group was based on clinical studies that assessed the safety and efficacy of Shingrix in adults who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for haematological malignancies.
Also, the studies generated additional safety and immunogenicity data in immunodeficient or immunosuppressed adults, due to known disease or therapy.
Breuer added: “In addition to this new patient population, there are more than 100 million adults 50 years and older in the US already recommended to receive Shingrix.
“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.”
Furthermore, the US Centres for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) is in talks to consider recommendations for use of Shingrix in immunocompromised adults.
