What was done on the 44,000 subjects was best described as a Phase IA trial, and for an immunological intervention, it was far too short for even purposes of determining short term safety profile. This is the main reason I refused to take this vaccine.
With the disclosures that the main trial arm was conducted with the development batches…
What was done on the 44,000 subjects was best described as a Phase IA trial, and for an immunological intervention, it was far too short for even purposes of determining short term safety profile. This is the main reason I refused to take this vaccine.
With the disclosures that the main trial arm was conducted with the development batches and not with the process batches is stunning to me, and I worked in drug development for 20 years.
Joe juice maker has to comply to GMP regulations through the FDA but the FDA allowed these pharma companies (which are on a waaaay higher level of regulation) to do things Joe juice maker would never get away with.
What was done on the 44,000 subjects was best described as a Phase IA trial, and for an immunological intervention, it was far too short for even purposes of determining short term safety profile. This is the main reason I refused to take this vaccine.
With the disclosures that the main trial arm was conducted with the development batches and not with the process batches is stunning to me, and I worked in drug development for 20 years.
I only worked in biologics for about five years and I am stunned the FDA would allow this.
Joe juice maker has to comply to GMP regulations through the FDA but the FDA allowed these pharma companies (which are on a waaaay higher level of regulation) to do things Joe juice maker would never get away with.