GSK's Shingrix Shingles Vaccine Awaiting Final Labeling Tweaks

US advisory committee unanimously impressed by the 90% plus efficacy; FDA says label may note lack of data in those who've previously had shingles.

The US FDA's Vaccines and Related Biological Products Advisory Committee enthusiastically recommended approval of GlaxoSmithKline PLC 's shingles vaccine Shingrix, saying they were impressed by the efficacy data and that an "imbalance" in certain adverse events could be addressed in ongoing monitoring and evaluation.

During the panel's Sept. 13 meeting, several members praised GSK and FDA for the thorough analysis of the clinical data....