The anonymous guest in this interview has previously worked alongside Health Canada for pharmaceutical regulation and review as it pertains to marketing and pricing of market drugs. She holds a Doctor of Pharmacy and Bachelor of Science in Pharmacy, and together we dissect the recent British Medical Journal whistleblower publication regarding regulatory misconduct at the lab in Texas responsible for conducting one of Pfizer’s clinical trials.
We also going to discuss potentially deadly integrity issues and inconsistent manufacturing process that can occur, such as that which led to three lots of the Moderna COVID-19 vaccine being suspended in Japan due to stainless steel contaminants. Back in March, Health Canada went ahead with nearly two thirds of all total AstraZeneca imports coming from a lab accused by the FDA to have quality-control issues. The US FDA didn’t release any of the vaccines made at this lab to the US market — but Health Canada did.
Given some of this background, we also delve into the Pfizer leaked documents from March 2021 which showed manufacturing concerns and quality control issues. These issues with quality may help explain why some are more prone to vaccine adverse reactions than others. My guest also mentions the European Medical Association’s (EMA) review from December 2020, updated in February 2021, which delineated all the issues regarding the quality of the finished product — purity, truncated species, batch-to-batch standards, etc. On pages 36-41 of the EMA document are specific obligations that must be met, then there are recommendations.
We end the interview with my guest urging for a pause, a thorough review of regulatory issues, and for indiscriminate mandates to be stopped for such an uncertain and complicated product.