January 1, Pfizer whistleblower reveals data integrity issues in COVID vaccine trial

Brook Jackson, a former regional director of Ventavia Research Group, which tested Pfizer’s COVID-19 vaccine at several sites in Texas in autumn 2020, is blowing the whistle on data integrity and patient safety issues during the pivotal phase III trial.

Jackson said Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. According to The British Medical Journal (BMJ), quality control staff were overwhelmed by the number of problems they found.

Problems with laboratory management

After Jackson repeatedly informed Ventavia about the problems, she emailed a complaint to the Food and Drug Administration (FDA). Later that same day, Ventavia fired her. Jackson provided dozens of internal company documents, photos, audio recordings, and emails to The BMJ.

In her September 25 email to the FDA, Jackson listed concerns she’d witnessed, including:

• Participants placed in a hallway after injection and not being monitored by clinical staff
• Lack of timely follow-up of patients who experienced adverse events
• Protocol deviations not being reported
• Vaccines not being stored at proper temperatures
• Mislabelled laboratory specimens
• Targeting of Ventavia staff for reporting these types of problems

One photo showed needles improperly discarded in a plastic biohazard bag instead of a sharps container. Another image showed vaccine packaging with trial participants’ identification numbers left out in the open, potentially unblinding the participants.

Ventavia, which has won awards for its contract work, was not keeping up with data entry queries. ICON, the contract research organization that partnered with Pfizer on the trial, emailed Ventavia in September 2020. “The expectation for this study is that all queries are addressed within 24hrs,” ICON wrote.

ICON then highlighted more than 100 outstanding queries older than three days in yellow, including the following: “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.”

Ventavia and the FDA

In August 2021, after the full approval of Pfizer’s vaccine, the FDA published its inspections of the pivotal phase III trial. Nine of the 153 sites were inspected — none of which were Vantavia’s sites.

“The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug],” the FDA’s inspection officer wrote.

Other employees weigh-in

Two other former Ventavia employees spoke to The BMJ on the condition of anonymity over fear of repercussions, confirming the broad aspects of Jackson’s complaint.

One said she’d worked on more than four dozen clinical trials in her career but had never encountered such a “helter skelter” work environment.

“I’ve never had to do what they were asking me to do, ever,” she said. “It just seemed like something a little different from normal—the things that were allowed and expected.”

After Jackson left Ventavia, the problems persisted, according to the employee. The company didn’t have enough employees to swab all trial participants who reported COVID-like symptoms. An FDA memo from August 2021 said swabs were not taken from 477 people with suspected cases of symptomatic COVID-19.

“I don’t think it was good, clean data,” the employee said of the Ventavia data. “It’s a crazy mess.”

Since Jackson contacted the FDA in September 2020, Pfizer has hired Ventavia as a subcontractor on four other vaccine clinical trials: COVID-19 vaccine in children and young adults, pregnant women, a booster dose, and an RSV vaccine trial.

Source:

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial