Report highlights irregularities in how FDA approved COVID-19 vaccines, drugs

The report was the outcome of a journalist’s investigation of FDA documents.

At Research Centers of America in Hollywood, Florida, on August 18, 2020, during the phase 3 trial of Moderna’s COVID-19 vaccine. | Photo Credit: LEILA MACOR/AFP

An investigation by a journalist, Maryanne Demasi, of official regulatory documents of the US Food and Drug Administration has highlighted irregularities in the agency’s approval of the vaccines and drugs for COVID-19 developed under “Operation Warp Speed”, a public-private partnership initiated by the US government. The report was published by The British Medical Journal (BMJ).

According to the report, only nine out of 153 trial sites for Pfizer-BioNTech’s mRNA vaccine were subject to FDA inspection prior to licensing. Similarly, only 10 out of 99 trial sites for Moderna’s mRNA vaccine and five of 73 trial sites for the drug remdesivir were inspected.

Apparently, the FDA had received a complaint from Brook Jackson, a former FDA regional director, about misconduct at three clinical trial sites that were testing Pfizer’s vaccine. Jackson noticed several 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,” Jackson stated. The FDA did not, however, inspect the trial sites in question.

The FDA told The BMJ that despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, it only had 89 inspectors for its bioresearch monitoring programme, which is responsible for guaranteeing the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications. “I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” Jill Fisher, professor of social medicine at the University of North Carolina, told The BMJ.

“The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she added. Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and carried out only “mission critical” inspections when actually this was the time it should have ramped up its oversight.