COVID vaccine safety. Pfizer trial issues

Clinical trials for vaccines are important not only to test new vaccines for efficacy but also for safety. Source.

The major medical journal BMJ recently published an article on issues with Pfizer’s COVID vaccine trial, reporting: “for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails… A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research… 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”. Source.

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