RALEIGH, N.C. (WNCN) — A report in a medical journal is raising questions about the results from one research company that helped with Pfizer’s trials for its COVID-19 vaccine.
But should it make you any less confident in the vaccines themselves?
Short answer: No.
“I think that that could be an unnecessary focus and anxiety about this breaking story,” said Dr. Jill Fisher, a professor of social medicine at the University of North Carolina and an expert on clinical trials.
The story published this week in the British Medical Journal lays out issues raised by a now-former employee of Ventavia Research Group, one of the companies contracted to help run some of Pfizer’s Phase III clinical trials.
The employee, former regional director Brook Jackson, told the publication that some paperwork may have been left out in the open, potentially unblinding some of the participants. Among her other concerns: Participants were not properly monitored by clinical staff after their injections, vaccines not being stored at the right temperature and mislabeling of specimens.
Paul Thacker, the investigative journalist who wrote the story, told CBS 17 that it raised questions about “what was this process like? Was this good data?”
Peter Doshi, the publication’s senior editor, said Thacker’s story was subject to the same rigorous peer review that scientific studies published by The BMJ are.
Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson.
“Ventavia takes research compliance, data integrity, and participant safety very seriously and stands behind its important work supporting the development of lifesaving vaccines and is conducting its investigation accordingly,” she said.
The report was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism.
Even Thacker acknowledged that “people are going to use this to push a political position because that’s what they’re interested in.”
But Fisher — who has authored books on the subject of clinical trials and was quoted in Thacker’s story — says that’s the wrong takeaway.
“I think that’s definitely a narrative that’s out there,” she said. “And I don’t think that’s necessarily a fair narrative.”
With millions of North Carolinians — and billions of people around the globe fully vaccinated — researchers have plenty of real-world data that show the safety and efficacy of the vaccines.
The Pfizer Phase III trial involved 44,000 people and 153 locations. From August 2020 through Sept. 17, 2020 — when she was fired — Jackson told CBS 17 that Ventavia accounted for at least 1,200 of those people and accounted for three sites.
“If all of the clinical trial data were dependent on one particular site, and that site’s data were called into question, I think it would be a much bigger concern,” Fisher said.
The more important takeaway, she said, is the need for improved oversight in clinical trials.
“We’re really interested in the story because it is about COVID-19. And it’s about vaccines. But I think it’s really a much more important story about just how clinical research is done, what kinds of organizations and companies are part of it,” Fisher said. “And really, I think it also points to the fact that the FDA is incredibly under resourced, and they just cannot do the kinds of inspections and investigations that might be required.”
CBS 17’s Joedy McCreary has been tracking COVID-19 figures since March 2020, compiling data from federal, state, and local sources to deliver a clear snapshot of what the coronavirus situation looks like now and what it could look like in the future.