FDA allowed safety of Covid vaccines to be authorized with 2 months of safety data
5 months ago
22
Dr. Peter Marks, FDA: "In order to get vaccines to people in need when thousands of people were dying, we actually allowed the safety to be authorized with just 2 months of medium follow-up rather than the normal 6-12, but we were confident that that would capture adverse events. So we had good safety data and then when we went to finally do the biologics license application we go through very large data sets...The safety of the Covid-19 vaccines includes that there are some initial discomfort potentially in the arm, fatigue...there are rarely more serious side effects. We identified myocarditis and rare allergic reactions and thankfully by putting mitigation strategies in place both of those have been decreased in occurrence."
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