Brook Jackson, an employee at Ventavia Research Group, one of the clinical research companies contracted by Pfizer for phase III clinical trials of its coronavirus vaccine, reported “Irregularities” and the performance of “bad practices” during the tests. Based on a series of statements and the presentation of robust evidence, he called into question some aspects of the procedure and the performance of the FDA (Food and Drug Administration) that should have been in charge of monitoring the situation, especially in a pandemic context. The disseminated data acquire greater relevance because they were published in the journal British Medical Journal.
“The documents show that the problems occurred for weeks,” the article states at the beginning. What happened specifically? In 2020, a group of employees of Ventavia, in Texas (USA), began to notice irregularities in the phase III procedure of the anticovid vaccine developed by Pfizer. Jackson, after repeated conversations with his superiors about the anomalies that he detected, compiled a series of tests and sent them directly to the FDA, the regulatory body of that country (equivalent to Anmat in Argentina), so that they would be aware of what it happened.
In her testimony, the complainant described – through photos, recordings, emails and other evidence – that the volunteers of the vaccine at that site were placed in a corridor and were not monitored by medical staff, I affirm that no follow-up opportune of those people who presented adverse effects and who the blind man was not respected (Thus, the confidentiality of who received the placebo and who the active substance was violated). He also assured that protocol deviations were not reported correctly that the professionals did, that poorly trained vaccinators were employed so whatThe vaccines were not stored at the correct temperatures. In parallel, he included photos showing discarded needles in a biohazard plastic bag instead of using a box of sharps containers. Following the complaint, the company employee who worked for Pfizer she was fired.
Lack of transparency
“The British Medical Journal is a very respectable journal in the field, it is an excellent publication to which we must pay attention. If it is a transparency complaint, it must of course be given place. The work does not question either the efficacy or the safety of the vaccineInstead, it concentrates on describing some irregularities in the testing procedure. The fact that situations like this are known can function as an alert for the companies themselves that, in many cases, being so large, do not control the process in all its links ”, he says. Jorge Geffner, biochemist and senior researcher at Conicet.
In this sense, from a more critical perspective, the virologist from Conicet expresses it Mario Lozano placeholder image: “The Ventavia company was in charge of the tests of a thousand people. If all the contractors who worked with Pfizer were handled in the same way it would be extremely serious. This does not seem to be the situation because the vaccine did not generate major problems, “he says. And then he underlines: “I can’t help but think about the scandal that would have caused if these data had been made public in state-owned companies such as those that make Sinopharm or Sputnik V. Some media would be spitting hours of speech in order to describe how bad these vaccines are. On the contrary, an event like this does not tarnish the quality of Pfizer, but it must be taken into account ”, says the former rector of the National University of Quilmes.
Pfizer’s vaccine trials were conducted on more than 40,000 people around the globe. In fact, one of the main locations where they took place was the Military Hospital of Argentina. In local territory, the tests were conducted by the infectious disease doctor Fernando Polack and the Fundación Infant team.
A controller that does not control
In September 2020, a few days after submitting the evidentiary material, Jackson received a call from an FDA inspector to discuss his report. However, after listening to her, they told her that they “could not provide her with further information” on how the matter would proceed. Days later, he heard nothing more in relation to his complaint. In August 2021, following the full approval of Pfizer’s vaccine, the FDA released a summary of its trial inspections. In summary, nine of the 153 centers were monitored. The Ventavia center in Texas, of course, was not included among the nine. This event brings to the surface the role of regulatory authorities, who must control this type of situation and, in many cases, do not do so in a relevant way.
“They are serious flaws in the procedure that obviously were not analyzed and reviewed by the United States health authority. There is a geopolitical approach with an order from the federal government to get a vaccine as soon as possible and for his agency to look the other way when there are problems, ”says Lozano. Then he continues: “The vaccine is still good because of a situation like this. However, I think you have to keep an eye on this type of event because it is clear that Pharmaceuticals are commercial companies whose main criteria are to obtain profit, financial return before health. And if the control body does not control well, it represents a real risk ”.
Its safety and efficacy are not in doubt
The speed with which pharmaceutical and biotech companies launched themselves into the race for the production of vaccines that could somehow slow the spread of covid, the quoted text suggests, may have had some effect on the integrity of the data and the volunteer safety. “In history, pharmaceutical companies have paid multimillion-dollar compensation for irregularities in other investigations involving volunteers. The power they have is impressive, they fight head to head with very powerful industries such as the military. Ensuring transparency and publicity of their actions must be a standard that all laboratories comply with equally ”, says Geffner. And he concludes: “In any case, vaccines work very well and the reality is that Pfizer’s technology is excellent. There is half the planet immunized and there is no doubt that millions of lives have been saved”.