FDA
22nd November 2017

FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine

The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster.

FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine

The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) -Shingrix™, manufactured by GlaxoSmithKline Biologicals (GSK). The committee voted unanimously (11 Yes, 0 No, 0 Abstain) that the data was adequate to support both the safety and efficacy of Shingrix for the prevention of herpes zoster (shingles) in adults 50 years of age and older.

In clinical trials, Shingrix showed greater protection against shingles among older recipients than that demonstrated by Zostavax, the currently available shingles vaccine. Four years after injection, the GSK vaccine remained about 90% effective in people over age 70, while the efficacy of Zostavax declined noticeably over time. Shingrix was also found to reduce the incidence of nerve pain following a shingles outbreak. In two pivotal Phase III studies, which included more than 29,000 subjects, serious side effects were similar for Shingrix and a placebo.

Committee members had concerns about a small increase in some reported adverse events among Shingrix subjects, such as gout and stroke. However, the sponsor has proposed a post-approval safety monitoring plan to investigate whether Shingrix is the cause of these adverse health issues. Panelists also stated that it would have been valuable to see more data from other populations, since the vast majority of trial subjects were white.

The committee commented that they were impressed with the efficacy data presented, and encouraged the sponsor wherever possible to broaden future clinical trials to include a more diversified population.  In addition, the committee was also satisfied with the comprehensive analysis of the safety data presented, and supported GSK’s post licensure pharmacovigilance plan. While the FDA is not required to follow the advice of its expert panels, it normally does so, and Shingrix was granted approval for prevention of shingles in adults aged 50 and over on October 20th, 2017 by the Agency.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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