WASHINGTON (Pakistan Point News / Sputnik - 03rd November, 2021) Researchers involved with the clinical trials for Pfizer's COVID-19 vaccine engaged in poor scientific practices that compromised the integrity of the data, The BMJ reported, citing a former employee of the research organization.
The Ventavia Research Group falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial, former regional director Brook Jackson said, according to the report on Tuesday.
Jackson emailed a complaint to the US food and Drug Administration (FDA) following complaints from fellow employees who were overwhelmed by the volume of problems they were finding during the research. She was later fired by Ventavia later that same day, the reports said.
Ventavia, which bills itself as the largest privately owned clinical research company in Texas, reportedly discarded used needles in plastic bags instead of dedicated sharps containers and left materials with trial participants' personal information out in the open, according to photos reportedly given to The BMJ by Jackson.
Jackson said that she received a call from an FDA inspector to discuss the report she emailed the organization, but heard nothing further following the call.
Two other former Ventavia employees spoke to The BMJ on condition of anonymity and confirmed broadly aspects of Jackson's allegations of poor scientific research practices by the company, adding that they persisted after Jackson was fired.
One of the former employees said they had worked on over four dozen clinical trials in their career, but that none had the sort of "helter skelter" work environment that the Pfizer trial at Ventavia had.
Pfizer has hired Ventavia as a research subcontractor for four other vaccine clinical trials since Jackson reported the alleged problems to the FDA: a trial for COVID-19 vaccines in children and young adults, in pregnant women and as a booster dose, as well as a Respiratory Syncytial Virus vaccine.
