Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.
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