New Delhi: Medical journal The BMJ has reported alleged data integrity issues in the clinical trials of the Covid vaccine manufactured by US pharma giant Pfizer and its German partner BioNtech.
Quoting a whistleblower — a sacked employee of one of firms employed for the conduct of the trial — the journal wrote Tuesday: “… the company 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”.
Despite the fact that Covid was the primary outcome of the trial, operations were so “messy” that sometimes the company allegedly didn’t even have sufficient employees to take swabs of trial participants who had developed Covid-like symptoms, the journal reported.
These could potentially affect the way conclusions were reached in the double blind trial.
Under double blind trials, neither participants nor researchers know who got the vaccine and who got the placebo. As participants develop the infection, their status is noted, and in the final analysis “unblinding” happens when the correlation between the vaccine and infection and the efficacy or lack of it, is calculated using methods of biostatistics.
An estimated 418.41 million doses of the Pfizer vaccine have been administered across the world as of 3 November.
India hasn’t given approval to the vaccine. The company had applied last year for regulatory clearance but withdrew the application earlier this year. One of the sticking points was the unwillingness of the Government of India to give Pfizer indemnity against legal liability in case untoward incidents happened to vaccine recipients.
The allegations in The BMJ have been made quoting emails and communications from an employee of the research organisation Ventavia Research Group, who the article claimed, had approached the US Food and Drug Administration (FDA) to flag the violations in trial protocol and best practices.
The journal also spoke to two other Ventavia employees, who corroborated the accounts of the whistleblower.
ThePrint reached Pfizer for a comment over email. The company confirmed that the query has been received, adding that it would be replied to shortly. However, there was no response until the time of publishing this report. It will be updated when a response is received.
Also read: US authorises Pfizer Covid vaccine for children aged 5 to 11
Ventavia sites were not inspected by FDA
Brook Jackson, the Ventavia employee who flagged the violations she noticed during her 15 days stint in the company — she was fired after she approached the FDA — also spoke to The BMJ about the alleged fear within the company about a possible inspection by the drug regulator.
However, in the end, the sites managed by Ventavia were not inspected.
“In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation,” the journal wrote.
Among the violations Jackson flagged were lack of monitoring of trial participants and timely follow-up of those that reported adverse events following immunisation, non-reporting of protocol deviations, vaccines not being stored at proper temperatures, mislabelling of laboratory specimens and targeting employees who reported these problems.
“A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place,” the journal wrote.
“Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial…)”.
(Edited by Amit Upadhyaya)
Also read: Why Covaxin for kids is stuck despite clinical trial clearing expert committee test