Who licenses, recommends and requires vaccines?
Vaccines, like prescription drugs, are only given to children after a long and careful review by a number of different groups. These different groups either license, recommend or require vaccines. Licensure The first of three processes, licensure, involves gaining approval from the Food and Drug Administration (FDA). As a result, it is the longest of these processes. It can take years, even decades, before pharmaceutical companies can actually start providing the vaccine. For example, the varicella vaccine took about 11 years to be licensed by the FDA. Vaccines are usually made by first showing that they are safe and effective in experimental animals. Once this is established, the vaccine becomes an Investigational New Drug (IND) and the company is given an IND license to further study the safety and effectiveness of the vaccine in adults, and eventually, children. Again, these trials can take years, giving companies ample time to provide the FDA with proof of long-term safety and effe
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