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FDA Violated Own Safety Standards In Approving Covid-19 Vaccines For Children


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Issues & Insights

The FDA recently authorized Pfizer’s and Moderna’s Covid-19 vaccines for children as young as six months. Troublingly, the evidence the FDA used for those decisions violates at least three safety and efficacy standards from earlier FDA publications about Covid-19 vaccines:

  1. In 2021, the FDA warned that “antibody tests should not be used to evaluate a person’s level of immunity or protection from Covid-19 at any time, and especially after the person received a Covid-19 vaccination.” Yet, antibody tests are the main evidence the FDA cited when approving these vaccines for young children.
  2. In 2021, the FDA declared, “We know from our vast experience with other pediatric vaccines that children are not small adults,” and thus, a “comprehensive evaluation of clinical trial data” is necessary to “support of the safety and effectiveness” of vaccines before they are “used in a younger pediatric population.” Yet, the FDA used small studies with narrow data and claimed these vaccines are effective and safe for children by extrapolating from studies done on adults.
  3. In 2021, the FDA wrote that “the primary study objective” is that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19. Yet, none of the studies on young children met this threshold, and some were negative, meaning that the vaccine could increase the chances of catching Covid-19 :snip:
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