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Abstract
Biological products must meet specifications defined by clinical studies. The product release model for vaccines details product specifications related to potency, stability, safety, and efficacy. The number of doses children receive in one administration of the product is highly variable based on manufacturing variability, stability, and shelf life. Changes to the vaccine product, including overfilling, are not detailed in the package insert and are granted regulatory approval prior to clinical safety testing. The product label is missing key information required for informed consent.