FDA Committee Gives Thumbs Up to New Shingles Vaccine Shingrix
The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee has voted unanimously in support of the approval of Shingrix, a non-live, recombinant subunit vaccine for the prevention of herpes zoster in adult patients ≥50 years old.
"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,” said Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GlaxoSmithKline.
Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response.
While not bound by the Advisory Committee's recommendation, the FDA takes its guidance into consideration. The FDA's decision on the approval of Shingrix is expected in October 2017.
For more information visit GlaxoSmithKline.com.