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GSK Shingles Vaccine's Next Stop Is CDC Panel After US FDA Approval

 
• By Brenda Sandburg

Shingrix's 90%-plus efficacy and reduction in postherpetic neuralgia gives GSK's vaccine edge over Merck's Zostavax. CDC advisory committee to vote on lower age for vaccination and use in Zostavax recipients.

Shingrix Zoster Vaccine

GlaxoSmithKline PLC leveraged a US FDA advisory committee to help get a strong label for its shingles vaccine Shingrix. Now the company hopes a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) will all but guarantee strong sales for the product.

FDA approved Shringrix on Oct. 20 for prevention of herpes zoster (shingles) in adults aged 50 years and older. In...

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• By Sue Sutter

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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New EU Approvals

 
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