Paul D. Thacker: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial, in: BMJ 375 (November 2, 2021) n2635, online in: https://doi.org/10.1136/bmj.n2635.
In the fall of 2020, chairmann and chief executive Albert Bourla stated in an open letter that accurately predicting an approval date for a Pfizer vaccine in the U.S. would be difficult. He reminded the audience that they were “operating at the speed of science”. Researchers who participated in Pfizer’s vaccine trials complained that the picked up speed might be detrimental to data integrity and patient safety. Allegations were made that data had been falsified and that the blind studies had been cancelled. In addition, inadequately trained vaccinators had been employed and adverse outcomes had been followed up slowly. The regional director of the research organization Ventavia Research Group, Brook Jackson, sent a complaint to the US Food and Drug Administration (FDA) after repeatedly pointing out the overbuirdening workload of the staff performing the quality controls. She was subsequently fired the same day and provided dozens of internal company documents, photos, audio recordings and emails to the BMJ.