Child C-19 Vaccines
Which of the following FDA standards did the FDA violate when approving mRNA Covid-19 vaccines for children?
Correct Answer
In 2022, the FDA approved Pfizer's and Moderna's m-RNA Covid-19 vaccines for children as young as six months while violating at least three explicit safety and efficacy standards from earlier FDA publications about Covid-19 vaccines: 1) "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." 2) "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 the safety and effectiveness" of vaccines before they are "used in a younger pediatric population." 3) "The primary study objective" is that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19.
DocumentationChild C-19 Vaccines