18 June 2020 — Telesur English
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
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.
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.
Some manufacturers might pretend that their endpoint is a demonstration that the volunteers have produced “neutralizing antibodies” against the virus, as determined from assays of their serum in test tubes. If so, then people are being deceived, and the supposed vaccines may offer no protection at all in a real encounter with a virus. In vitro results quite often do not hold up to their promise. After all, every drug that has failed in animal and human trials would not have been tried if it had not first worked in vitro.
The three major potential anti-COVID-19 vaccines that are in the run right now and zipping right along to phase two or three, are arguably Moderna’s mRNA-1273, Astra Zeneca’s AZD1222 (previously ChAdOx1 nCoV-19), and Sinopharm’s BBIBP-CorV.
Moderna’s project is a much-touted mRNA vaccine, for which a phase one trial began in mid-March with 45 human volunteers, and a phase two trial with 600 volunteers was approved a mere six weeks after the start of phase one. The company enjoys US$483 million from BARDA, an apparent blank check from CEPI to get its drug to phase two, plus funds from DARPA and Anthony Fauci’s NIAID. During the phase one trial, three healthy volunteers who received 250 micrograms of mRNA-1273 developed “grade three adverse effects,” meaning that they became so sick that they could not function for one day or more. One 29-year-old man vomited, fainted, and developed a more than 103 F fever that lasted about five hours. The phase two trial will presumably use 50 or 250 micrograms of mRNA-1273. It gives little confidence to know that Moderna’s top executives have cashed out US$89 million of their shares of stock as its value has climbed from US$20 in early January to US$87 on May 22. Currently, the public is being prepared for a flare-up of COVID-19 in Seattle and Atlanta, presumably because of massive anti-racism Black Lives Matter protests. No one is asking about the Moderna vaccine trials in Seattle and Atlanta that have potentially created many asymptomatic carriers of SARS-CoV-2.
Astra Zeneca has developed its potential vaccine, called AZD1222, together with the University of Oxford, although the company controls about eight percent of Moderna’s stock. Astra Zeneca got a whopping US$1.2 billion from BARDA on May 21, 2020, and is a darling of U.S. President Donald Trump’s Operation Warp Speed, which has promised to deliver hundreds of millions of doses of a supposedly efficacious vaccine to Americans by January 2021. Their immunization approach is to administer an injection of 50 billion particles of a chimpanzee adenovirus that has been engineered to make the SARS-CoV-2 spike protein. In an initial animal study, five out of six supposedly immunized monkeys developed COVID-19 symptoms: specifically, they became infectious, with viral RNA in their nasal passages, after they were exposed to SARS-CoV-2 four weeks “post-vaccination.” Such results would normally kill a project, but not for Astra Zeneca. They spun their damning results by boasting that their injections had prevented illness because the monkeys did not get pneumonia. They are plowing through a 1,000-volunteer phase one study in southern England that started on April 23 and pushing phase 2/3 trials with more than 10,000 volunteers. Interestingly, about 10,000 protesters marched through Brighton, on the southern coast of England, on June 13 in solidarity with the Black Lives Matter movement. Might we expect a COVID-19 surge there too?
Last but not least is Sinopharm, a Chinese State project that involves the China National Pharmaceutical Group, together with the Beijing Institute of Biological Products, the Chinese Center for Disease Control and Prevention, and other major health concerns based in Beijing. Sinopharm has been secretive about its plans and merely announced that it was working on a potential vaccine based on the inactivated virus, with promising results in animals and “early human tests” underway. But the group just published a paper in the journal Cell that describes the animal studies. Their potential vaccine is called BBIBP-CorV, and some aspects of it should have raised more questions with Cell. For example, the same dosage is reported to work on mice, rats, rabbits, and monkeys. Sinopharm also claims to have observed no Antibody-Dependent Enhancement of disease (ADE). In other words, it is among the first to assert that the supposedly immunized animals did not become gravely ill – worse than the controls — after they were exposed to SARS-CoV-2. Considering that ADE has routinely been observed in laboratories that have attempted to vaccinate animals against coronaviruses, the paper should have explained how Sinopharm met this challenge. Coincidentally, Beijing has so far had a surge of about 80 new COVID-19 cases. Chinese health authorities are mandating extreme lockdown and blaming the cases on the Xinfadi market, the city’s largest wholesale food market. Conveniently, all the tests of recent visitors to the market have turned up positive, though this is actually an impossibility.
We have been promised a second wave of COVID-19, and we will surely get one. I propose that it will not happen because of the popular uprisings, winter cold, or any of the other hypotheses that have been put forward to prepare us for it. Instead, it will probably be due to the free circulation of tens of thousands of volunteers from various failed vaccine trials. In the U.S., China, and several Western countries, pharmaceutical concerns are becoming an arm of the military-industrial complex. In the West, the main motivation is a desire for a piece of the large pie of military budget. In China, it is an aspiration for greater prestige in the world and conquest of the hearts and minds of citizens of other countries, particularly the global south. The supposedly greater race consciousness that has erupted from the Black Lives Matter protests could soon turn into a racist call for the mandatory vaccination of mostly black and brown low-wage workers, for their own good. Racism is alive and well, and the Vaccine Cold War is on. What we are experiencing is analogous to the fallout from the atmospheric nuclear tests of the first Cold War. We are being played like fish near a hook.
Dr. Dady Chery is an Associate Professor of Biology, Co-Editor-In-Chief of News Junkie Post, and the author of We Have Dared to Be Free: Haiti’s Struggle Against Occupation.