New Zoster Vaccine Recommended by FDA Panel Save
Reuters reports that the Food and Drug Administration (FDA) advisory panel has voted 11-0 in favor of the safety and efficacy and ultimate approval of GlaxoSmithKline’s Shingrix shingles vaccine for use in adults aged 50 and over.
The proposed inactive vaccine against H. zoster (HZ) was previously reported to be more effective than the current live vaccine Zostavax made by Merck. (https://buff.ly/2y6zuvg)
The herpes zoster beta subunit vaccine was shown to be more than 90% effective (for 4+ years) in HZ prevention and post-herpetic neuralgia prevention, especially in those over age 70 yrs. - claims that exceed that seen with the current vaccine.
Shingrix has the advantage of being an inactive (non-live) virus vaccine - that can be given to those who are immunosuppressed or receiving TNF inhibitors or other biologic agents. Shingrix has not been studied in those who are immunosuppressed or receiving TNF inhibitors or other biologic agents.
GSK is forecasting sales for this product to reach $1 billion by 2023. In contrast, Zostavax, approved in 2006, is expected to generate sales of about $730 million this year.
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