A paper has revealed that the Food and Drug Administration (FDA) exhibited a lax attitude toward safety concerns about the Wuhan coronavirus (COVID-19) vaccines, which the agency later approved.
- The paper by Australian investigative journalist Maryanne Demasi was published Nov. 16 in BMJ Investigation.
- She revealed the FDA exhibited lax attitude regarding the oversight of COVID vaccine and drug trials
- Only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine
- Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir vaccine sites were inspected
Former FDA advisor accuses agency of ‘endangering public health’
- David Gortler, a former senior advisor to the FDA commissioner, remarked that the regulator is “endangering [public health] by not being candid about the violations uncovered during clinical trial site inspections.”
- The FDA paused site inspections during the peak of COVID-19 pandemic restrictions between March and July 2020, with only “mission-critical inspections” being carried out.
- During a pandemic, the FDA could’ve put inspectors in hazmat suits if they wanted to, but they didn’t.
No comments:
Post a Comment