The U.S. Food and Drug Administration (FDA) is planning to add the most serious “Black Box” warning to Covid-19 vaccines. This decision, which has not yet been finally approved, is seen as an attempt by the administration of U.S. President Donald Trump to fuel distrust in vaccines.
The “Black Box” warning is the FDA’s strictest regulatory measure. It alerts consumers to risks of death, life-threatening events, or permanent disability, which must be carefully weighed against the benefits of the vaccine. Similar warnings are currently applied to opioids (due to the risk of addiction) and the smallpox vaccine (due to the risk of heart inflammation). Industry experts are shocked, stating that the imposition of this warning has no scientific basis.
The initiator of the plan has been identified as FDA Chief Medical Officer Dr. Vinay Prasad, known for his criticism of vaccination policies during the Covid-19 pandemic. Last month, Prasad circulated an internal memo claiming that FDA staff had “found at least 10 children died after and because of Covid-19 vaccination,” although he has not publicly released the data to support this.
Besides Prasad, the administration’s vaccine skeptic, Secretary of Health and Human Services Robert F. Kennedy Jr., is actively supporting critical positions regarding vaccine safety.
The safety of Pfizer and Moderna vaccines is being monitored globally by more than 90 regulatory bodies, which both companies confirm, noting that the latest data have not revealed any new safety concerns. According to CDC data, the Covid-19 vaccine prevented nearly 20 million deaths globally in its first year of use and significantly reduced the risk of virus-related emergency hospitalizations in children last season.
The previously existing risk included in the vaccine labeling was myocarditis, a rare side effect primarily seen in males aged 12 to 24, although the majority of cases resulted in recovery.
Health specialists express concern over the lack of public disclosure in the process and the scarcity of scientific data. Experts at Harvard University note that no public review by independent experts has been conducted, which is essential for decisions of this kind. They warn that such actions, dictated by political goals instead of science, could potentially undermine public trust in life-saving vaccines.
