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Shingrix Shingles Vaccine Submitted for FDA Review
GlaxoSmithKline (GSK) has submitted a biologics license application for its candidate shingles vaccine Shingrix to the FDA, seeking approval for the prevention of herpes zoster (shingles) in people 50 years of age or over.
The nonlive recombinant vaccine is designed to help prevent shingles and its complications. Phase 3 data showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with shingles. Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses, with a two- to six-month interval between doses.
The regulatory submission for Shingrix was based on a comprehensive phase 3 clinical trial program evaluating the vaccine’s efficacy, safety, and immunogenicity in more than 37,000 subjects. This includes the ZOE-50 and ZOE-70 studies, which were published in the New England Journal of Medicine in April 2015 and September 2016, respectively.
The candidate vaccine combines glycoprotein E, a protein found on the varicella zoster virus (VZV) that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunologic response to the antigen. GSK intends to register the product as Shingrix, subject to approval by the FDA.
Shingles typically presents as a painful, itchy rash that develops on one side of the body as a result of reactivation of latent VZV. Data from many countries indicate that more than 90% of adults have been infected with VZV during childhood. The individual lifetime risk of developing shingles is approximately one in three for people in the United States; however, this increases to one in two people 85 years of age or older. A person’s risk for shingles increases sharply after the age of 50 because of a natural age-related decline in immune system function, or as a consequence of an underlying immunocompromising condition.
The most common complication from shingles is PHN, defined as localized pain of significant intensity persisting at least 90 days after the appearance of the acute shingles rash. Other complications of shingles include ophthalmologic, neurologic, and cutaneous disease, which can result in severe disability.
A clinical study is under way to evaluate revaccination with Shingrix in subjects who have previously been vaccinated against shingles with the currently available live-attenuated vaccine. Additional trials are being conducted in patients with solid or hematologic cancers, in hematopoietic stem-cell and renal-transplant recipients, and in people infected with human immunodeficiency virus (HIV). According to GSK, these studies will provide additional information on the candidate vaccine’s safety and ability to stimulate immune responses in populations at high risk of shingles because of the weakening of their immune systems.
Source: GlaxoSmithKline; October 24, 2016.