The change from 60+ to 50+ occurred because the company did a study with over 22,000 people in it (half getting the vaccine) and showed that it was safe and effective in a patient population between the ages of 50-59. The approval initially was based on a study in people over 60. The way drug approvals work is, you only get approval for the patient population you studied. So the company had to do another study in order to get approval for the vaccine in patients between 50-59. It wasn't pressure from Merck but actual data that got them the change in the label to include younger patients.
The FDA website contains information about the approval of drug and biologic products that the public can read.
http://www.fda.gov/downloads/Biologi.../UCM249230.pdf
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Thread: Shingles PSA
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06-25-2011, 11:23 AM #1
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Last edited by Possegal; 06-25-2011 at 02:45 PM.
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