Production & Manufacturing
Process & Production

FDA advisory panel recommends approval of GSK’s shingles vaccine Shingrix

PBR Staff Writer Published 14 September 2017

An advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline’s (GSK) Shingrix vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and over.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) had unanimously voted that the data tabled by GSK supported the efficacy and safety of its shingles candidate vaccine.

FDA’s advisory committees provide the regulator with non-binding recommendations for its considerations. However, the final decision on approval of Shingrix vaccine will be made by the FDA.

GSK senior vice president and vaccines R&D head Dr. Emmanuel Hanon said: “Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles.

“Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.”

Shingrix is a combination of the glycoprotein E antigen and the AS01B adjuvant system. It has been developed to create an immune response in the body that is strong and long lasting to help in making up for the decrease in immunity that is associated with aging.

According to GSK, the non-live, recombinant subunit vaccine has the ability to help in shingles preventions and its complications including postherpetic neuralgia in adults aged 50 years and above.

GSK had submitted the Biologics License Application (BLA) of Shingrix vaccine to the FDA in October 2016.

Currently, Shingrix has not been approved anywhere in the world yet for the prevention of shingles. GSK is the process of regulatory filings of the shingles vaccine candidate in the European Union, Japan, Canada and Australia.

Image: GSK House in Brentford, London. Photo: courtesy of GlaxoSmithKline plc.