FDAnews Drug Daily Bulletin

FDA Committee Gives Thumbs Up to Shingrix

Sept. 20, 2017

An FDA advisory committee unanimously endorsed GlaxoSmithKline’s Shingrix as a safe and effective vaccine for herpes zoster (shingles) in adults 50 and over.

The decision, by the Vaccines and Related Biological Products Advisory Committee, is non-binding but boosts the chances the FDA will approve the pending application for the vaccine.

Shingrix is a non-live, recombinant subunit vaccine for shingles and its complications, such as postherpetic neuralgia, GSK says.

Herpes zoster is the same virus that causes chicken pox. It can lay dormant for years after childhood and then cause shingles, a painful rash with blisters, in older individuals or those with weakened immune systems.

Merck’s Zostavax is the only FDA-approved shingles vaccine.

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