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WASHINGTON – The U.S. Food and Drug Administration (FDA) announced it plans to soon release a report with data that, according to its own analysis, shows a possible association between the COVID-19 vaccine and 25 deaths in children. The revelation has sparked intense debate in the medical, scientific, and political communities regarding the safety of vaccines administered during the pandemic.

According to a preview of the document, the FDA emphasized that the identified cases are still under review and do not constitute definitive evidence of causality. “These data are preliminary and should be interpreted with caution,” said an agency spokesperson, who insisted that the vaccines are still considered safe and effective in preventing severe COVID-19 and associated mortality.

The announcement comes at a time when various sectors of American society are demanding greater transparency regarding the adverse effects of biologics approved during the health emergency. Public health experts warned that the release of the report could fuel misinformation and provide new ammunition for anti-vaccine movements, despite the fact that the vast majority of international studies continue to confirm a positive balance of safety and efficacy.

Meanwhile, Republican lawmakers have demanded congressional hearings to evaluate the FDA's findings and question the accelerated approval processes used during the pandemic. For its part, the White House called for calm and reaffirmed its confidence in regulatory agencies, while highlighting that childhood vaccination has contributed to reducing hospitalizations and deaths from COVID-19 in children.

The full FDA report will be presented in the coming weeks to an independent advisory committee, tasked with evaluating the available evidence and issuing updated recommendations on the use of vaccines in the pediatric population.