The Food and Drug Administration (FDA) inspected only a small handful of clinical trial sites where the COVID-19 vaccines were being tested, according to a Wednesday report from the British Medical Journal. FDA documents show the agency inspected only 9 out of 153 Pfizer trial sites, 10 out of 99 Moderna trial sites and five out of 73 Remdesivir trial sites.
The FDA paused its site inspections for the COVID-19 vaccines between March-July 2020 ostensibly due to COVID-19 and related restrictions. Only “mission critical” inspections were conducted.
BMJ reports that the FDA adapted its guidelines to travel restrictions and now allows for “remote regulatory assessments,” i.e., virtual inspections using video conferencing and live streaming.
The senior adviser to the FDA Commissioner during the rollout of the shots mocked the idea of “remote inspections”.
“You can’t do a remote inspection,” he said. “That’s like saying I’m going to arrest somebody remotely. You have to be there on site and look at every nuance such as cleanliness, organisation, staff coordination—even their body language. During a pandemic, the FDA could’ve put inspectors in hazmat suits if they wanted to, there’s no excuse for not going onsite.”
The report comes amid a high-profile lawsuit against Pfizer and clinical site inspection company Ventavia for numerous FDA regulatory violations during the vaccine trials.
Ventavia whistleblower Brook Jackson, who was a clinical site reviewer for two of the vaccine’s trial sites, was fired after reporting “blatant” and “widespread” misconduct she witnessed to the FDA, including “numerous violations of the U.S. Food and Drug Administration (FDA) Code of Federal Regulations every, single day.”
Jackson alleges that Pfizer, Ventavia and ICON, another clincial research group, “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”
According to the suit, the companies also “concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.”
In June, America’s Frontline News reported that Pfizer moved to dismiss the lawsuit because even if the allegations are true, the U.S. government endorsed it by purchasing 100 million doses for $1.95 billion.
“Pfizer has moved to dismiss the case, and their grounds to dismiss as they repeated in the scheduling conference we had this week is that it doesn’t matter if they had submitted fraudulent certifications to the government,” said Jackson’s attorney Robert Barnes. “It doesn’t matter if they submitted false statements under penalty of perjury to the government. It doesn’t matter if they lied about the safety and efficacy of these drugs mislabeled, in my opinion, as vaccines, because the government was in on it with them! The government knows what’s going on and the government still would have given them the check anyway! So is it really fraud if the government’s their co-conspirator? That is in essence Pfizer’s defense so far to the case.”