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news.GlaxoSmithKline’s (GSK) Shingrix (Zoster Vaccine Recombinant, Adjuvanted) vaccine has been approved by the US Food and Drug Administration (FDA) for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
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The non-live, recombinant subunit vaccine has been indicated to be given intramuscularly in two doses.
Shingrix, which combines glycoprotein E antigen with the AS01B adjuvant system, works by developing a strong and long lasting immune response in the body.
Glycoprotein E is a protein identified on the shingles-causing varicella zoster virus while AS01B aims to boost the immunological response to the antigen. Their combination in Shingrix is claimed to compensate for the loss of immunity related to age.
GSK Vaccines senior vice president and chief medical officer Dr. Thomas Breuer said: “Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States.
“The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity.”
GSK secured the FDA approval of Shingrix based on a phase 3 trial in over 38,000 people where efficacy was registered in a majority of them by the vaccine in all age groups.
Shingrix, by preventing shingles, also decreased the overall incidence of postherpetic neuralgia (PHN), a type of chronic nerve pain and the most common complication related to the painful skin rash condition.
Shingrix has now been approved in Canada and the US for shingles prevention in people of 50 years or more. GSK is pursuing approval for the shingles vaccine across the European Union, Australia and Japan.
The company plans to make Shingrix available shortly in the US pending a recommendation from the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).
Image: GSK House in Brentford, London. Photo: courtesy of GlaxoSmithKline plc.
