The U.S. Food and Drug Administration has issued a warning letter to Dr. Americo F. Padilla and the Miami Dade Medical Research Institute for failing to adhere to regulatory requirements in a clinical trial involving pediatric patients.

According to the FDA, Dr. Padilla’s research, which involved testing a COVID-19 vaccine on children, violated federal regulations by enrolling two pediatric subjects without obtaining legally effective parental or guardian consent. The agency cited these infractions as serious breaches of human protection guidelines.

The FDA inspected a research site and found that the trial did not meet the required ethical and procedural standards. Under U.S. regulations, investigators must ensure that parents or legal guardians provide consent before minors participate in clinical trials. The failure to comply with this requirement raises ethical and legal concerns about the integrity of the study and patient safety.

"We are particularly concerned about the severity of the violations and their potential effect on subjects’ rights, since pediatric subjects are considered a vulnerable population," noted the FDA in the warning letter.

Dr. Padilla and his research institute have been instructed to address these deficiencies and provide corrective actions. The FDA has warned that failure to comply with federal regulations could result in further enforcement actions, including potential disqualification from conducting clinical trials in the future.

For further details, refer to the full FDA warning letter: FDA Official Website.