Biologics

FDA Oversight of Pfizer Covid Contractor Questioned

David McFarland

— 2 min read
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A regional director at Ventavia Research Group, which provides Covid-19 vaccine research services to Pfizer, says she had many concerns about problems at Ventavia that she raised with FDA the same day she was fired after two weeks on the job. The whistleblower, Brook Jackson, told the BMJ (formerly British Medical Journal) the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in the Pfizer Phase 3 pivotal trial. Jackson provided the journal with internal company documents, photos, audio recordings, and e-mails.

Among the concerns Jackson listed in an e-mail to FDA were: 

  •          participants placed in a hallway after injection and not 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;
  •          mislabeled laboratory specimens; and
  •          targeting of Ventavia staff for reporting these types of problems. 

The article reports that Jackson received a return e-mail from FDA thanking her for her concerns and notifying her that the agency could not comment on any investigation that might result. A few days later she received a call from an agency inspector to discuss her report but was told that no further information could be provided.

The journal says that a briefing document submitted by Pfizer to an FDA 12/10/2020 advisory committee meeting on a request for emergency use authorization (EUA) for the Covid-19 vaccine did not reference any problems at Ventavia sites and the EUA was approved the next day.

In an FDA summary of its inspections of Pfizer’s pivotal trial published 8/2020, the agency said it inspected nine of the company’s 153 trial sites. None of the Ventavia sites were among those inspected.

The BMJ says it spoke with other former Ventavia employees who confirmed “broad aspects” of Jackson’s complaint. It says one former employee described the data Ventavia generated for the Pfizer trial as “a crazy mess” and “not good clean data.”

Since Jackson reported her concerns to FDA in 9/2020, the journal says, Pfizer has hired Ventavia as a research subcontractor on four other vaccine trials, including three with the Covid-19 vaccine.

In response to an FDA Webview request for comments on the report, the agency said it was an “ongoing matter” and could not formally comment. FDA did, however, say it has full confidence in the data that were used to support the Pfizer-BioNTech Covid-19 vaccine authorization.

 

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