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FDA Approves New Shingles Vaccine for Adults

Accepted submission by takyon at 2017-10-23 18:44:11
Science

https://www.statnews.com/2017/10/20/shingles-vaccine-approval/ [statnews.com]

The Food and Drug Administration on Friday approved a second shingles vaccine, giving pharmaceutical giant GlaxoSmithKline a go-ahead to market Shingrix in the United States.

The FDA approval marks the second regulatory green light for the vaccine in a week's time. Last Friday Shingrix was approved for sale in Canada. Regulatory filings are also in the works for the European Union, Australia, and Japan, GSK said.

The vaccine offered 98 percent protection in the first year and that protection remained at 85 percent or higher three years after vaccination — stronger protection than the only other shingles vaccine on the market, Merck's Zostavax.

GSK has been keenly awaiting the FDA's ruling, eager to get to market a vaccine analysts estimate could reach $1 billion a year in sales by 2022.

Also at FiercePharma [fiercepharma.com] and The Pharma Letter [thepharmaletter.com].


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