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Results Wire: US FDA Advisory Committee Unanimously Supports Shingrix, a Shingles Vaccine Proposed by GlaxoSmithKline – SEP 13, 2017 (VRBPAC)

Background

On Wednesday, September 13, 2017, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) supported, by unanimous votes of 11-Yes to 0-No, with no abstentions, the safety and effectiveness of Zoster Vaccine Recombinant, Adjuvanted, by GlaxoSmithKline Biologicals (GSK). The proposed trade name is Shingrix.

Key Outcomes of Advisory Meeting

The Committee voted unanimously (11 of 11 members) that the available data are adequate to support the efficacy and the safety of Shingrix in adults 50 years of age and older.

In their discussions of the efficacy data ...

A few representative comments of the Committee members regarding efficacy are show below.

...

The Committee felt that the safety of Shingrix ...

A few representative comments of the Committee members regarding safety are show below.

...

There was one speaker in the open public hearing portion of the meeting, ...

Overall Voting Results

1. VOTE: Are the available data adequate to support the efficacy of Shingrix for prevention of herpes zoster (shingles) in adults 50 years of age and older?

11-Yes

0-No

0-Abstain

2. VOTE: Are the available data adequate to support the safety of Shingrix when administered to adults 50 years of age and older?

11-Yes

0-No

0-Abstain

METADATA: Sponsor: GlaxoSmithKline Biologicals Drug Name: Zoster Vaccine Recombinant, Adjuvanted Drug Class: vaccine Indication: varicella zoster virus


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