The snags in the research protocol reported by one of Pfizer’s subcontractors are of a “problematic”, “worrying” or “disturbing” nature, but they do not call into question the efficacy and safety of the vaccine against COVID-19, assure several Quebec experts consulted by Press.
A Pfizer subcontractor, which carried out clinical trials on its vaccine in the fall of 2020, made several breaches of the research protocol, reveals the medical journal British Medical Journal (BMJ) citing a whistleblower.
“For researchers testing Pfizer’s vaccine at multiple sites in Texas, speed may have come at the cost of data integrity and patient safety,” writes the BMJ in a survey released Tuesday.
“It’s always disturbing when you hear about things that haven’t been done properly,” admits Dr.r André Veillette, researcher at the Montreal Clinical Research Institute (IRCM) and member of the federal working group on COVID-19 vaccines.
“The comfort we can have is that the results of Pfizer’s phase II and III studies have been confirmed worldwide,” he recalls. “It is clear that these vaccines are safe and effective. ”
The reported subcontractor is the Ventavia Research Group (VRG), a private company founded in Texas in 2013, which operates research sites in nine cities across the state.
the BMJ quotes a whistleblower with more than 15 years of experience in the management and coordination of clinical research, who worked for two weeks at Ventavia in September 2020. After informing the company of multiple issues, including follow-up of events Too slow junk and gaps in staff training, she filed a complaint with the Food and Drug Administration (FDA), and was fired the same day.
“This is worrying, especially for clinical studies,” notes Alain Lamarre, professor and researcher specializing in immunology, virology and cancer at the National Institute for Scientific Research (INRS).
“On the other hand, does that call into question the entire integrity of the process? I don’t think so, ”he says, pointing out that it’s about 1,000 patients at three sites, while the clinical trial as a whole had about 44,000 at 153 sites.
The fact that there are many other sites than those “identified as problematic” allows regulatory bodies to make a solid assessment, also believes Dr Denis Leclerc, professor of medical biology at the Faculty of Medicine of Laval University. “It’s reassuring,” he said. You can do a strong statistical analysis and make good recommendations. ”
Two other former employees with long experience in clinical trials have also indicated that they have never seen a work environment as messy as at Ventavia, reports the BMJ.
5 to 11 year olds
These denunciations come as the vaccination of 28 million Americans aged 5 to 11 has just received the green light. The FDA granted emergency clearance for the Pfizer-BioNTech vaccine last Friday, and the Centers for Disease Control and Prevention (CDC) recommended it on Tuesday, saying administration could begin “as soon as possible.”
Canada has yet to vote on the petition submitted by Pfizer-BioNTech on October 18.
Health Canada should seek an explanation from Pfizer of the claims published by the BMJ, estimates the Dr Night watch.
“I have no doubt that they are going to cover it all, but it would be good if the public were as sure as they are going to do it. It is their responsibility. ”
Health Canada was unable to answer questions from Press about it Wednesday.
The Ministry also had to rectify the situation after sowing concern with a tweet evoking months of waiting for 5 to 11 years.
Tuesday night’s post, which was withdrawn, was a mistake, admitted a spokesperson, who said he was “sorry for any confusion this may have caused.”
“The request will in fact be reviewed in the coming weeks,” said the first in a series of tweets published Wednesday on the Twitter account of Health Canada and the Public Health Agency of Canada.
SCREENSHOT, THE PRESS
A tweet from the Ministry sowed concern on Tuesday evening before being withdrawn.
It will still be necessary to wait “a few weeks” before the approval, had for its part indicated the chief medical adviser of Health Canada, Supriya Sharma, in press conference Friday.
“I don’t see a decision before the middle or the end of November, at the earliest,” she said. It depends on the data and back and forth [pour les valider]. ”
The Quebec government has already declared that it will be ready to give a first dose to children aged 5 to 11 by Christmas. But once Health Canada approval is granted, it will also have to wait for the recommendation of the Quebec Immunization Committee to move forward.
– With Mylène Crête, Press