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Little refresher: according to the CDC, an adverse reaction is an undesirable medical condition that has been demonstrated to be caused by a medical product. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site (if applicable), or recurrence of the condition with repeated dosage. Adverse reactions are synonymous with “side effect” or “adverse effect.”
Two types of adverse reactions are listed in an insert. The first are adverse reactions identified from Clinical Trials Experience. Typically Section 6.1, the manufacturer will most likely have a lengthy section dedicated to their clinical trials.
Per the FDA, here’s a quick look at the three phases of clinical trials.
The average person would assume a control group is a placebo which is a supposedly inert substance such as a sugar pill or injection of sterile water, given under the guise of effective treatment. However, that is not the case with all clinical trials. Let’s continue with our DTAP example:
Because of this, I personally do not spend much time in this section. Many do not have confidence in the clinical trial findings when placebos are anything but sterile water or sugar pills.
Head to the next lesson to learn about the second type of adverse reactions listed in manufacturer inserts.