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Investigation Raises Concerns About Poor FDA Oversight of Clinical Trials

COVID-19 vaccines and drugs were developed at "warp speed" and now experts are concerned about the US Food and Drug Administration's (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.

Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its COVID-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected, writes investigative journalist Maryanne Demasi.

Notably, the FDA received a complaint from whistle-blower Brook Jackson, about misconduct at three clinical trial sites that were testing Pfizer's COVID-19 vaccine, while she was employed as a regional director. Jackson observed a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. "I thought that the FDA was going to swoop in and take care of everything," said Jackson. The FDA did not, however, inspect the trial sites in question.