GlaxoSmithKline (NYSE:GSK) received permission from FDA to expand the use of its Shingrinx shingles vaccine to include immunocompromised and immunosuppressed adults 18 years old or older.
Having won initial FDA approval in 2017 for individuals 50 and older, the shingles (herpes zoster) vaccine is a non-live, recombinant subunit adjuvanted vaccine. Shingrix is the first shingles vaccine to win an indication for people who are immunodeficient or immunosuppressed.
Approximately 1 million people develop shingles in the U.S. each year, according to the CDC.
GSK has gained shingles vaccine market share since November 2020, when Merck (NYSE:MRK) discontinued Zostavax, a rival shingles vaccine. Zostavax initially won approval in 2017 and was previously the only shingles vaccine available in the U.S.
The FDA decided based on clinical studies involving adults 18 or older who had undergone an autologous hematopoietic stem cell transplant (auHSCT). Additionally, it reviewed a posthoc analysis from vaccine recipients who had received treatment for hematological malignancies. The agency also reviewed safety and immunogenicity data in adults likely to be immunodeficient or immunosuppressed due to HIV, solid tumors or kidney transplants.
The COVID-19 pandemic has resulted in slowing shingles vaccination rates. A recent report from Avalere Health that received support from GSK concluded that the pandemic forced more adults to miss more than 17 million vaccine doses.