Dear Editor
Maryanne Demasi describes the low-key approach to the FDA’s supervision of covid-19 vaccine trials.
The Pfizer trial had in fact 130 research sites in the USA, but still less than 7% of these sites were inspected by the FDA (1).
Worldwide there were 153 sites. Pfizer conducted their own audits (2), but only in 23 sites (15%).
Seven of these audits were described as “non-routine”. These included the sites in Fort Worth (five weeks after Brook Jackson’s complaint to the FDA (3)) and in Argentina, which contributed 13% of the total trial participants and was the only centre to be audited twice by Pfizer.
The requirements for an internal non-routine audit are not specified.
The trial sponsors should have a duty to disclose the outcomes of these audits.
1. Polack FP, Thomas SJ et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine. 2020;383(27):2603-15.
2. https://phmpt.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-…
3. BMJ 2021;375:n2635
Clinical Trials and “Oversight”