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The FDA can issue emergency use authorization for vaccines, but only if there is “no adequate, approved, and available alternative to the [vaccine] for diagnosing, preventing, or treating” the illness in question. Any inoculation approved on an emergency basis must also be proven effective in preventing disease – a feat no drug manufacturer had accomplished for a human coronavirus prior to 2020. A number of previous attempts failed to pass the animal stage of trials, as the vaccines ended up causing more severe infections in the test subjects, a phenomenon dubbed “vaccine-associated enhanced respiratory disease” in the FDA’s guidelines.
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