In the fast-track system, a pharmaceutical company hardly examines the results of a phase one trial before moving on to phases two and three. | Photo: NIAID
By Dady Chery
An FDA “fast-track” designation has essentially accorded a carte blanche to a set of vaccines that are financed by CEPI, an alliance of Bill Gates with the six biggest pharmaceutical companies
If the English-language press had done its job, and not parroted press releases that promote vaccination as the only escape from the social isolation we’ve endured the last three months, the public would be asking many questions about the ongoing protests and their relation to the logistics of vaccine trials. To test a vaccine, typically a pharmaceutical company recruits healthy volunteers for several phases of a clinical trial with a defined endpoint.
I have previously noted that an FDA “fast-track” designation has essentially accorded a carte blanche to a set of vaccines that are financed by CEPI, an alliance of Bill Gates with the six biggest pharmaceutical companies, and in many cases also by the U.S. Homeland Security and Department of Defense concerns BARDA and DARPA.
In the fast-track system, a pharmaceutical company hardly examines the results of a phase one trial before moving on to phases two and three, even though phase one is supposed to identify the best dose for safety on a small group of 15 to 50 healthy volunteers, and phase 2/3 is supposed to follow up with a test of efficacy and an expansion of the test for safety to a larger group. For any vaccine worth its name, the endpoint is a dose that is not only safe in the short and long term but also protects the volunteers from the infectious agent.
Yes, this does imply that the volunteers get exposed to the infectious agent as part of the trial, even though I would challenge you to find this fact being spelled out anywhere in the news. Since the volunteers are typically young and healthy, the expectation for a vaccine candidate against COVID-19 is that, if it fails, as most vaccine candidates do, the volunteers will not become deathly ill on exposure to the virus but will merely turn into asymptomatic carriers. Enter the WHO, which declares on June 8, 2020, without any obvious prompting, that asymptomatic transmission of SARS-CoV-2 appears to be “very rare.” The WHO “doth protest too much, methinks.” This is much too convenient a discovery right now.
The WHO statement contradicts numerous observations and at least one recent review of the coronavirus literature. The review states that “asymptomatic persons seem to account for approximately 40 to 45 percent of SARS-CoV-2 infections, and they can transmit the virus to others for an extended period, perhaps longer than 14 days.” It is actually 21 days but never mind all that. The WHO has found another paper, not yet in the press, that says what it likes. A CDC-approved vaccine typically guarantees over US$1 billion in profit for its manufacturer. When it comes to that kind of money, it appears that any report may be concocted. One important reason for the WHO to make this declaration is probably to absolve from liability the manufacturers that are, as I write this article, injecting their potential vaccines into volunteers and then exposing them to SARS-CoV-2, without any provision whatsoever for a quarantine period or the facilities for one […]