GSK’s Shingrix shingles vaccine clears an FDA hurdle
GlaxoSmithKline (GSK) said its Shingrix vaccine, indicated for the prevention of herpes zoster (commonly known as shingles) in older adults, recently attained unanimous preliminary approval from a U.S. Food and Drug Administration (FDA) advisory committee.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) came to consensus regarding the efficacy and safety for the vaccine's use by individuals age 50 and over, a GSK release said. The panel's recommendations are non-binding as the final approval must come from the FDA itself. The interim endorsement comes less than year after an application was submitted in October 2016.
“Shingles is a painful and potentially serious condition,” Dr. Emmanuel Hanon, senior vice president and head of vaccine research and development for GSK, said in the release. “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.”
Caused by the same virus that brings on chickenpox, shingles usually surfaces as a blistering and painful rash. Approximately 1 million cases are reported in the U.S. annually with comparable numbers elsewhere in North America as well as in Europe and the Asia-Pacific, the release said.
The candidate vaccine contains an antigen (glycoprotein E) and an adjuvant system AS01B to compensate for the immune system’s decline in ability to respond to infection as people age.
“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,” Hanon said in the release.
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